MedWatch - August 2007 Safety-Related Drug Labeling Changes

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Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2007

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.

Summary View

Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Actos (pioglitazone hydrochloride) Tablets Prescribing Information See MedWatch Safety Alert posted 08/14/2007 for additional information on recent FDA Press Release and Information for Healthcare Professionals.	BOXED WARNING (new) Congestive Heart Failure CONTRAINDICATIONS WARNINGS Cardiac Failure and Other Cardiac Effects Prospective Pioglitazone Clinical Trial In Macrovascular Events (PROactive) PRECAUTIONS Edema ...Since thiazolidinediones, including Actos, can cause fluid retention, which can exacerbate or lead to congestive heart failure, Actos should be used with caution in patients at risk for heart failure. Patients should be monitored for signs and symptoms of heart failure...	BOXED WARNING: Congestive Heart Failure Thiazolidinediones, including Actos, cause or exacerbate congestive heart failure in some patients (see WARNINGS). After initiation of Actos, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to the current standards of care. Furthermore, discontinuation or dose reduction of Actos must be considered. Actos is not recommended in patients with symptomatic heart failure. Initiation of Actos in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated... CONTRAINDICATIONS Initiation of Actos in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated... WARNINGS: Cardiac Failure and Other Cardiac Effects ...If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of Actos must be considered (see BOXED WARNING). Patients with NYHA Class III and IV cardiac status were not studied during pre-approval clinical trials and Actos is not recommended in these patients... WARNINGS: Prospective Pioglitazone Clinical Trial In Macrovascular Events (PROactive) ...In patients treated with an insulin-containing regimen at baseline, the incidence of serious heart failure was 6.3% (n=54/864) with Actos and 5.2% (n=47/896) with placebo. For those patients treated with a sulfonylurea-containing regimen at baseline, the incidence of serious heart failure was 5.8% (n=94/1624) with Actos and 4.4% (n=71/1626) with placebo.

Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets Prescribing Information See MedWatch Safety Alert posted 08/14/2007 for additional information on recent FDA Press Release and Information for Healthcare Professionals.	BOXED WARNING (new) Congestive Heart Failure CONTRAINDICATIONS WARNINGS Rosiglitazone maleate Cardiac Failure and Other Cardiac Effects	BOXED WARNING: Congestive Heart Failure Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients (see WARNINGS, Rosiglitazone maleate). After initiation of Avandamet, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of Avandamet must be considered. Avandamet is not recommended in patients with symptomatic heart failure. Initiation of Avandamet in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated... CONTRAINDICATIONS Initiation of Avandamet in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated... WARNINGS: Rosiglitazone maleate/Cardiac Failure and Other Cardiac Effects ...If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of rosiglitazone must be considered (see BOXED WARNING). Avandamet should be discontinued if any deterioration in cardiac status occurs...

Avandaryl (rosiglitazone maleate and glimepiride) Tablets Prescribing Information See MedWatch Safety Alert posted 08/14/2007 for additional information on recent FDA Press Release and Information for Healthcare Professionals.	BOXED WARNING (new) Congestive Heart Failure CONTRAINDICATIONS WARNINGS Rosiglitazone Cardiac Failure and Other Cardiac Effects	BOXED WARNING: Congestive Heart Failure Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients (see WARNINGS, Rosiglitazone). After initiation of Avandaryl, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of Avandaryl must be considered. Avandaryl is not recommended in patients with symptomatic heart failure. Initiation of Avandaryl in patients with established NYHA Class III or IV heart failure is contraindicated... CONTRAINDICATIONS Initiation of Avandaryl in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated (see BOXED WARNING)... WARNINGS: Rosiglitazone/Cardiac Failure and Other Cardiac Effects ...If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of rosiglitazone must be considered (see BOXED WARNING)...

Avandia (rosiglitazone maleate) Tablets Prescribing Information See MedWatch Safety Alert posted 08/14/2007 for additional information on recent FDA Press Release and Information for Healthcare Professionals.	BOXED WARNING (new) Congestive Heart Failure CONTRAINDICATIONS WARNINGS Cardiac Failure and Other Cardiac Effects	BOXED WARNING: Congestive Heart Failure Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients (see WARNINGS). After initiation of Avandia, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of Avandia must be considered. Avandia is not recommended in patients with symptomatic heart failure. Initiation of Avandia in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated... CONTRAINDICATIONS Initiation of Avandia in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated (see BOXED WARNING)... WARNINGS: Cardiac Failure and Other Cardiac Effects ...If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of rosiglitazone must be considered (see BOXED WARNING)...

Celexa (citalopram hydrobromide) Tablets and Oral Solution Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Celexa... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Celexa or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Cymbalta... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Cymbalta or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Diovan (valsartan) Tablets Prescribing Information	BOXED WARNING Use in Pregnancy WARNINGS Fetal/Neonatal Morbidity and Mortality PRECAUTIONS Information for Patients Pregnancy Female patients of childbearing age should be told about the consequences of exposure to drugs that act on the renin-angiotensin system. Discuss other treatment options with female patients planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.	BOXED WARNING: Use in Pregnancy When used in pregnancy, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus... WARNINGS: Fetal/Neonatal Morbidity and Mortality ...In addition, first trimester use of ACE inhibitors, a specific class of drugs acting on the renin-angiotensin system, has been associated with a potential risk of birth defects in retrospective data. Healthcare professionals that prescribe drugs acting directly on the renin-angiotensin system should counsel women of childbearing potential about the potential risks of these agents during pregnancy...

Effexor (venlafaxine hydrochloride) Tablets Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Effexor... Drug Interactions Drugs Metabolized by Cytochrome P450 Isoenzymes Metoprolol MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Effexor or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Effexor XR... Drug Interactions Drugs Metabolized by Cytochrome P450 Isoenzymes Metoprolol MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Effexor XR or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Lexapro (escitalopram oxalate) Tablets and Oral Solution Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Lexapro... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Lexapro or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Limbitrol (chlordiazepoxide) (amitriptyline HCI) DS (double strength) Tablets Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Limbitrol... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illness, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Chlordiazepoxide and Amitriptyline Hydrochloride Tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Marplan (isocarboxazid) Tablets Contact Validus Pharmaceuticals at 1-866-9VALIDUS for current prescribing information. Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS TO PHYSICIANS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medications, Depression and other Serious Mental Illness, and Suicidal Thoughts and Actions" is available for Marplan... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Marplan or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS TO PHYSICIANS: Clinical Worsening and Suicide Risk Contact Validus Pharmaceuticals for revised labeling.

Nardil (phenelzine sulfate tablets, USP) Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Nardil... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Nardil or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Parnate (tranylcypromine sulfate) Tablets Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS TO PHYSICIANS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions" is available for Parnate... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Parnate or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS TO PHYSICIANS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Paxil (paroxetine hydrochloride) Tablets and Oral Suspension Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions" is available for Paxil... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or action? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Paxil or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions" is available for Paxil CR... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or action? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Paxil CR or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Pexeva (paroxetine mesylate) Tablets Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Pexeva (paroxetine mesylate)... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Pexeva (paroxetine mesylate) or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Prozac (fluoxetine capsules, USP, fluoxetine oral solution, USP, fluoxetine delayed-release capsules, USP) Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Prozac... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Prozac or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Sertraline Hydrochloride Tablets and Oral Concentrate Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 Serotonin Syndrome PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for sertraline hydrochloride... Drug Interactions Serotonergic Drugs Triptans MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression, and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Zoloft or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS See highlighted prescribing information for revised text.

Sinequan (doxepin HCl) Capsules and Oral Concentrate Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Sinequan... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Sinequan or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Surmontil (trimipramine maleate) Prescribing Information & Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Surmontil... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Surmontil or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Symbyax (olanzapine and fluoxetine HCl capsules) Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 2 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Symbyax... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Symbyax or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Tekturna (aliskiren) Tablets Prescribing Information	BOXED WARNING Use in Pregnancy WARNINGS Fetal Neonatal Morbidity and Mortality PRECAUTIONS Information for Patients Pregnancy Female patients of childbearing age should be told about the consequences of exposure to drugs that act on the renin-angiotensin system. Discuss other treatment options with female patients planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.	BOXED WARNING: Use in Pregnancy When used in pregnancy, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus... WARNINGS: Fetal/Neonatal Morbidity and Mortality ...In addition, first trimester use of ACE inhibitors, a specific class of drugs acting on the renin-angiotensin system, has been associated with a potential risk of birth defects in retrospective data. Healthcare professionals that prescribe drugs acting directly on the renin-angiotensin system should counsel women of childbearing potential about the potential risks of these agents during pregnancy...

Wellbutrin (bupropion hydrochloride) Tablets Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions" and other important information about using Wellbutrin is available for Wellbutrin... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Wellbutrin or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions" and other important information about using Wellbutrin SR is available for Wellbutrin SR... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Wellbutrin SR or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Wellbutrin XL (bupropion hydrochloride extended-release tablets) Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and Other Serious Mental Illness, and Suicidal Thoughts or Actions" and other important information about Wellbutrin XL is available for Wellbutrin XL... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Wellbutrin XL or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Zyban (bupropion hydrochloride) Sustained-Release Tablets Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 4 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and Other Serious Mental Illness, and Suicidal Thoughts or Actions" and other important information about using Zyban is available for Zyban... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Although Zyban is not indicated for treatment of depression, it contains the same active ingredient as the antidepressant medications Wellbutrin, Wellbutrin SR, and Wellbutrin XL. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Zyban or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Reclast (zoledronic acid) Injection Prescribing Information (in new labeling format) Patient Package Insert	CONTRAINDICATIONS Hypersensitivity to zoledronic acid or any components of Reclast WARNINGS & PRECAUTIONS Hypocalcemia and Mineral Metabolism Renal Impairment Osteonecrosis of the Jaw Pregnancy Musculoskeletal Pain Patients with Asthma ADVERSE REACTIONS Clinical Studies Experience Postmenopausal Osteoporosis Table 1 Renal Impairment Acute Phase Reaction Laboratory Findings Injection Site Reactions Osteonecrosis of the Jaw Atrial Fibrillation Ocular Adverse Events Postmarketing Experience DRUG INTERACTIONS Initial Paragraph Nephrotoxic Drugs USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category D Geriatric Use Hepatic Impairment PATIENT COUNSELING INFORMATION Information for Patients ...Most of these side effects occur within the first 3 days following the dose of Reclast... PATIENT PACKAGE INSERT (updated to include osteoporosis indication) What is the most important information I should know about Reclast? What is Reclast? What should I tell my doctor before getting Reclast? Tell your doctor about all the medicines you take... How will I receive Reclast? What are the possible side effects of Reclast? What is Osteoporosis?	CONTRAINDICATIONS: Hypersensitivity to zoledronic acid or any components of Reclast Hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported. WARNINGS & PRECAUTIONS See highlighted prescribing information for revised text.

Risperdal (risperidone) Tablets and Oral Solution Risperdal M-TAB (risperidone) Orally Disintegrating Tablets Prescribing Information (in new labeling format)	CONTRAINDICATIONS WARNINGS & PRECAUTIONS Orthostatic Hypotension Seizures ADVERSE REACTIONS Initial Section Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials - Schizophrenia Adult Patients with Schizophrenia Table 1 Pediatric Patients with Schizophrenia Table 2 Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials - Bipolar Mania Adult Patients with Bipolar Mania Table 3 Table 4 Pediatric Patients with Bipolar Mania Table 5 Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials - Autistic Disorder Table 6 Other Adverse Reactions Observed During the Premarketing Evaluation of Risperdal Discontinuations Due to Adverse Reactions Schizophrenia - Adults Table 7 Schizophrenia - Pediatrics Bipolar Mania - Adults Table 8 Bipolar Mania - Pediatrics Autistic Disorder - Pediatrics Dose Dependency of Adverse Reactions in Clinical Trials Extrapyramidal Symptoms Other Adverse Reactions Changes in Body Weight Changes in ECG Postmarketing Experience USE IN SPECIFIC POPULATIONS Pediatric Use Weight Gain Somnolence Hyperprolactinemia, Growth, and Sexual Maturation	CONTRAINDICATIONS Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been observed in patients treated with risperidone... WARNINGS & PRECAUTIONS Orthostatic Hypotension ...Syncope was reported in 0.2% (6/2607) of Risperdal-treated patients in Phase 2 and 3 studies in adults with schizophrenia... Seizures During premarketing testing in adult patients with schizophrenia, seizures occurred in 0.3% (9/2607) of Risperdal-treated patients, two in association with hyponatremia. Risperdal should be used cautiously in patients with a history of seizures.

Tegretol (carbamazepine, USP) Chewable Tablets and Suspension Tegretol-XR (carbamazepine extended-release tablets) Prescribing Information	CONTRAINDICATIONS WARNINGS Initial Section Usage in Pregnancy PRECAUTIONS General ...Cardiac conduction disturbance, including second and third degree AV heart block... ...AV heart block, including second and third degree block, have been reported following, Tegretol treatment. This occurred generally, but not solely, in patients with underlying EKG abnormalities or risk factors for conduction disturbances. Information for Patients Tegretol may interact with some drugs. Therefore, patients should be advised to report to their doctors the use of any other prescription or non-prescription medications or herbal products. Caution should be exercised if alcohol is taken in combination with Tegretol therapy, due to a possible additive sedative effect. Drug Interactions Agents that May Affect Tegretol Plasma Levels Effect of Tegretol on Plasma Levels on Concomitant Agents	CONTRAINDICATIONS ...Co-administration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Co-administration of carbamazepine with nefazodone is contraindicated. WARNINGS: Initial Section ...The use of Tegretol should be avoided in patients with a history of hepatic porphyria (e.g., acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda). Acute attacks have been reported in such patients receiving Tegretol therapy. Carbamazepine administration has also been demonstrated to increase porphyrin precursors in rodents, a presumed mechanism for the induction of acute attacks of porphyria. As with all antiepileptic drugs, Tegretol should be withdrawn gradually to minimize the potential of increased seizure frequency. WARNINGS: Usage in Pregnancy ...There have also been reports that associate carbamazepine with developmental disorders and congenital anomalies (e.g., craniofacial defects, cardiovascular malformations and anomalies involving various body systems). Developmental delays based on neurobehavioral assessments have been reported...

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Albenza (albendazole) Tablets Prescribing Information	WARNINGS PRECAUTIONS Information for Patients Laboratory Tests White Blood Cell Count Liver Function ADVERSE REACTIONS The following adverse events were observed at an incidence of < 1%: Blood and Lymphatic System Disorders Immune System Disorders Postmarketing Adverse Reactions Blood and Lymphatic System Disorders Hepatobiliary Disorders Skin and Subcutaneous Tissue Disorders Renal and Urinary Disorders	WARNINGS ...Albendazole has been shown to cause bone marrow suppression, aplastic anemia, and agranulocytosis in patients with and without underlying hepatic dysfunction... ...Patients with liver disease, including hepatic echinococcosis, appear to be more at risk for bone marrow suppression leading to pancytopenia, aplastic anemia, agranulocytosis, and leukopenia attributable to albendazole and warrant closer monitoring of blood counts. Albendazole should be discontinued in all patients if clinically significant decreases in blood cell counts occur....

Ceftin Tablets (cefuroxime axetil tablets) Ceftin for Oral Suspension (cefuroxime axetil powder for oral suspension) Prescribing Information	WARNINGS PRECAUTIONS General Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.	WARNINGS Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Ceftin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

NegGram Suspension (nalidixic acid, USP) Oral Suspension Prescribing Information	WARNINGS PRECAUTIONS Information for Patients ...diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.	WARNINGS Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including NegGram, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIED Prescribing Information	WARNINGS Kidney, Liver and Heart Transplant PRECAUTIONS Drug Interactions Drugs That May Potentiate Renal Dysfunction Other Drugs Methotrexate Drugs That Increase Cyclosporine Concentrations Antifungals Voriconazole Drugs/Dietary Supplements That Decrease Cyclosporine Concentrations Other Drugs/Dietary Supplements Oxcarbazepine Bosentan	WARNINGS: Kidney, Liver and Heart Transplant ...Patients taking cyclosporine should be warned to avoid excess ultraviolet light exposure... ...Transplant patients receiving cyclosporine are at increased risk for serious infection with fatal outcome...

Proquin XR (ciprofloxacin hydrochloride) Extended-Release Tablets Prescribing Information Patient Package Insert	WARNINGS Hypersensitivity Reactions PRECAUTIONS Information for Patients ...to discontinue Proquin XR treatment; rest and refrain from exercise; and inform their physician if they experience pain, inflammation, or rupture of a tendon. The risk of serious tendon disorders with quinolones is higher in those over 65 years of age, especially those on corticosteroids. ...diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible. Geriatric Use In general, elderly patients may be more susceptible to drug-associated effects on the QT interval... Patients over 65 years of age are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as ProQuin XR. ADVERSE REACTIONS Reported Postmarketing Adverse Events with Other Formulations of Ciprofloxacin Hepatic Failure (including fatal cases) PATIENT PACKAGE INSERT What are possible side effects of Proquin XR?	WARNINGS: Hypersensitivity Reactions ...Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones, including ciprofloxacin. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following: fever, rash, or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson Syndrome); vasculitis, arthralgia, myalgia, serum sickness; allergic pneumonitis; interstitial nephritis; acute renal insufficiency or failure; hepatitis; jaundice; acute hepatic necrosis or failure; anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities. The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted... Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Proquin XR, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Provigil (modafinil) Tablets Prescribing Information Patient Package Insert	WARNINGS Serious Rash, including Stevens-Johnson Syndrome (SJS) Angioedema and Anaphylactoid Reactions Multi-organ Hypersensitivity Reactions Psychiatric Symptoms PRECAUTIONS Cardiovascular System Patients using Cyclosporine Patients with Severe Renal Impairment Elderly Patients Information for Patients Allergic Reactions Drug Interactions CNS Active Drugs Methylphenidate Dextroamphetamine Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Mutagenesis Impairment of Fertility Pregnancy Pediatric Use PATIENT PACKAGE INSERT (updated)	WARNINGS: Serious Rash, including Stevens-Johnson Syndrome Serious rash requiring hospitalization and discontinuation of treatment has been reported in adults and children in association with the use of modafinil. Modafinil is not approved for use in pediatric patients for any indication... ...Rare cases of serious or life-threatening rash, including SJS, Toxic Epidermal Necrolysis (TEN), and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have been reported in adults and children in worldwide postmarketing experience... ...There are no factors that are known to predict the risk of occurrence or the severity of rash associated with modafinil. Nearly all cases of serious rash associated with modafinil occurred within 1 to 5 weeks after treatment initiation. However, isolated cases have been reported after prolonged treatment (e.g., 3 months). Accordingly, duration of therapy cannot be relied upon as a means to predict the potential risk heralded by the first appearance of a rash. WARNINGS: Angioedema and Anaphylactoid Reactions One serious case of angioedema and one case of hypersensitivity (with rash, dysphagia, and bronchospasm), were observed among 1,595 patients treated with armodafinil, the R enantiomer of modafinil (which is the racemic mixture). No such cases were observed in modafinil clinical trials. However, angioedema has been reported in postmarketing experience with modafinil. Patients should be advised to discontinue therapy and immediately report to their physician any signs or symptoms suggesting angioedema or anaphylaxis (e.g., swelling of face, eyes, lips, tongue or larynx; difficulty in swallowing or breathing; hoarseness). WARNINGS: Multi-organ Hypersensitivity Reactions Multi-organ hypersensitivity reactions, including at least one fatality in postmarketing experience, have occurred in close temporal association (median time to detection 13 days: range 4-33) to the initiation of modafinil... ...If a multi-organ hypersensitivity reaction is suspected, Provigil should be discontinued. Although there are no case reports to indicate cross-sensitivity with other drugs that produce this syndrome, the experience with drugs associated with multi-organ hypersensitivity would indicate this to be a possibility. WARNINGS: Psychiatric Symptoms Psychiatric adverse experiences have been reported in patients treated with modafinil. Postmarketing adverse events associated with the use of modafinil have included mania, delusions, hallucinations, and suicidal ideation, some resulting in hospitalization. Many, but not all, patients had a prior psychiatric history...

Pulmicort Turbuhaler (budesonide inhalation powder) for Oral Inhalation Only Prescribing Information Patient Package Insert	WARNINGS PRECAUTIONS General Information for Patients Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy: Teratogenic Effects Pediatric Use Geriatric Use ADVERSE REACTIONS Adverse Event Reports From Other Sources Glaucoma Cataracts PATIENT PACKAGE INSERT Before using your Pulmicort Turbuhaler What are the possible side effects of Pulmicort Turbuhaler? Storing your Pulmicort Turbuhaler How to know when your Pulmicort Turbuhaler is empty Further information about Pulmicort Turbuhaler	WARNINGS Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to Pulmicort Turbuhaler. Lung function (FEV1 or AM PEF), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids. In addition to monitoring asthma signs and symptoms, patients should be observed for signs and symptoms of adrenal insufficiency such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension. Transfer of patients from systemic corticosteroid therapy to Pulmicort Turbuhaler may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy, eg, rhinitis, conjunctivitis, arthritis, eosinophilic conditions, and eczema...

Rituxan (rituximab) Prescribing Information	WARNINGS Progressive Multifocal Leukoencephalopathy (PML) PRECAUTIONS Pregnancy Category C	WARNINGS: Progressive Multifocal Leukoencephalopathy (PML) JC virus infection resulting in PML and death has been reported in Rituxan-treated patients with hematologic malignancies or with autoimmune diseases for which Rituxan has not been approved. The majority of patients with hematologic malignancies diagnosed with PML received Rituxan in combination with chemotherapy or as part of a hematopoietic stem cell transplant. The patients with autoimmune diseases had a history of prior, and may also have had concurrent, immunosuppressive therapy and were diagnosed with PML within 12 months of their last infusion of Rituxan...

Trileptal (oxcarbazapine) Tablets and Oral Suspension Prescribing Information	WARNINGS Anaphylactic Reactions and Angioedema PRECAUTIONS Information for Patients Anaphylactic reactions and angioedema may occur during treatment with Trileptal. Patients should be advised to report immediately signs and symptoms suggesting angioedema (swelling of the face, eyes, lips, tongue or difficulty in swallowing or breathing) and to stop taking the drug until they have consulted with their physician... ADVERSE REACTIONS Postmarketing and Other Experience Body as a Whole Anaphylaxis...	WARNINGS: Anaphylactic Reactions and Angioedema Rare cases of anaphylaxis and angioedema involving the larynx, glottis, lips and eyelids have been reported in patients after taking the first or subsequent doses of Trileptal. Angioedema associated with laryngeal edema can be fatal. If a patient develops any of these reactions after treatment with Trileptal, the drug should be discontinued and an alternative treatment started. These patients should not be rechallenged with the drug (see WARNINGS, Patients with a Past History of Hypersensitivity Reaction to Carbamazepine subsection).

Tykerb (lapatinib) Tablets Prescribing Information (in new labeling format)	WARNINGS & PRECAUTIONS Interstitial Lung Disease/Pneumonitis ADVERSE REACTIONS Clincial Trials Experience Interstitial Lung Disease/Pneumonitis Lapatinib has been associated with interstitial lung disease and pneumonitis in monotherapy or in combination with other chemotherapies...	WARNINGS & PRECAUTIONS: Interstitial Lung Disease/Pneumonitis Lapatinib has been associated with interstitial lung disease and pneumonitis in monotherapy or in combination with other chemotherapies [see Adverse Reactions (6.1)]. Patients should be monitored for pulmonary symptoms indicative of interstitial lung disease or pneumonitis. Tykerb should be discontinued in patients who experience pulmonary symptoms indicative of interstitial lung disease/pneumonitis which are ≥ Grade 3 (NCI CTCAE).

Viramune (nevirapine) Tablets and Oral Suspension Prescribing Information	WARNINGS Hepatic Events Skin Reactions ADVERSE REACTIONS Postmarketing Surveillance Musculoskeletal Rhabdomyolysis associated with skin and/or liver reactions	WARNINGS: Hepatic Events ...Rhabdomyolysis has been observed in some patients experiencing skin and/or liver reactions associated with Viramune use... WARNINGS: Skin Reactions ...Rhabdomyolysis has been observed in some patients experiencing skin and/or liver reactions associated with Viramune use...

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Brand (Generic) Name	Sections Modified
Clinoril (sulindac) Tablets Prescribing Information Medication Guide	PRECAUTIONS SLE and Mixed Connective Tissue Disease In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease, there may be an increased risk of aseptic meningitis... ADVERSE REACTIONS Nervous System Aseptic meningitis (especially in patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease... NSAID MEDICATION GUIDE Table: NSAID medicines that need a prescription Vicoprofen Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAID, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.

Coumadin Tablets (warfarin sodium tablets, USP) Crystalline Coumadin for Injection (warfarin sodium for injection, USP) Prescribing Information See MedWatch Safety Alert posted 08/16/2007 for additional drug information on warfarin and labeling changes.	PRECAUTIONS Drug/Drug and Drug/Disease Interactions Exogenous Factors (Table) Specific Drugs Reported Ezetimibe Botanical (Herbal) Medicines Table: Botanicals that contain coumarins with potential anticoagulant effects Agrimony (added to list) New footnote, #1: Contains coumarins, has antiplatelet properties, and may have coagulant properties due to possible Vitamin K content. Considerations for Increased Bleeding Risk Coumadin is a narrow therapeutic range (index) drug, and additional caution should be observed when warfarin sodium is administered to certain patients... ADVERSE REACTIONS Potential adverse reactions to Coumadin may include... Adverse reactions reported infrequently include: hypersensitivity/allergic reactions, including anaphylactic reactions...

Diuril (chlorothiazide) Oral Suspension Prescribing Information	PRECAUTIONS Drug Interactions Non-steroidal Anti-inflammatory Drugs Including Selective Cyclooxygenase-2 (COX-2) Inhibitors

Humalog (insulin lispro injection, USP [rDNA origin]), U-100 Prescribing Information Patient Package Insert	PRECAUTIONS Drug Interactions ...Insulin requirements may be decreased in the presence of drugs with hypoglycemic activity, such as oral antidiabetic agents, salicylates, sulfa antibiotics, certain antidepressants (monoamine oxidase inhibitors), angiotensin-converting-enzyme inhibitors, angiotensin II receptor blocking agents, beta-adrenergic blockers, inhibitors of pancreatic function (e.g., octreotide), and alcohol. Beta-adrenergic blockers may mask the symptoms of hypoglycemia in some patients. PATIENT PACKAGE INSERT (updated)

Humalog Mix 50/50 (50% insulin lispro protamine suspension and 50% insulin lispro injection [rDNA origin]), U-100 Prescribing Information Patient Package Insert	PRECAUTIONS Drug Interactions ...Insulin requirements may be decreased in the presence of drugs with hypoglycemic activity, such as oral antidiabetic agents, salicylates, sulfa antibiotics, certain antidepressants (monoamine oxidase inhibitors), angiotensin-converting-enzyme inhibitors, angiotensin II receptor blocking agents, beta-adrenergic blockers, inhibitors of pancreatic function (e.g., octreotide), and alcohol. Beta-adrenergic blockers may mask the symptoms of hypoglycemia in some patients. PATIENT PACKAGE INSERT (updated)

Humalog Mix 75/25 (75% insulin lispro protamine suspension and 25% insulin lispro injection [rDNA origin]), U-100 Prescribing Information Patient Package Insert	PRECAUTIONS Drug Interactions ...Insulin requirements may be decreased in the presence of drugs with hypoglycemic activity, such as oral antidiabetic agents, salicylates, sulfa antibiotics, certain antidepressants (monoamine oxidase inhibitors), angiotensin-converting-enzyme inhibitors, angiotensin II receptor blocking agents, beta-adrenergic blockers, inhibitors of pancreatic function (e.g., octreotide), and alcohol. Beta-adrenergic blockers may mask the symptoms of hypoglycemia in some patients. PATIENT PACKAGE INSERT (updated)

Mycamine (micafungin sodium) for Injection Intravenous Infusion (not for IV bolus injection) Prescribing Information	PRECAUTIONS Carcinogenesis, Mutagenesis and Impairment of Fertility Hepatic carcinomas and adenomas were observed in a 6-month intravenous toxicology study with an 18-month recovery period of micafungin sodium in rats designed to assess the reversibility of hepatocellular lesions...

Renagel (sevelamer hydrochloride) Tablets Prescribing Information	PRECAUTIONS General The safety and efficacy of Renagel in patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders including severe constipation, or major GI tract surgery have not been established... ADVERSE REACTIONS ...and in very rare cases, intestinal obstruction and ileus.

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Brand (Generic) Name	Sections Modified
Astelin (azelastine hydrochloride) Nasal Spray (for Intranasal Use Only) Prescribing Information	ADVERSE REACTIONS Postmarketing Experience Vasomotor Rhinitis Atrial Fibrillation Palpitations

Elidel (pimecrolimus) Cream 1% Prescribing Information	ADVERSE REACTIONS Postmarketing Events General Skin Discoloration

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Brand (Generic) Name	Sections Modified
Arthrotec (diclofenac sodium/misoprostol) Tablets Prescribing Information Medication Guide	MEDICATION GUIDE: Non-Steroidal Anti-Inflammatory Drugs (NSAID) Table: NSAID medicines that need a prescription Vicoprofen Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAID, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.

Coreg CR (carvedilol phosphate) Extended-Release Capsules Prescribing Information Patient Package Insert	PATIENT PACKAGE INSERT (new)

Humulin 50/50 (50% human insulin isophane suspension and 50% human insulin injection [rDNA origin]), U-100 Patient Package Insert	PATIENT PACKAGE INSERT (updated)

Humulin 70/30 (70% human insulin isophane suspension and 30% human insulin injection [rDNA origin]), U-100 Patient Package Insert	PATIENT PACKAGE INSERT (updated)

Humulin N NPH (human insulin [rDNA origin] isophane suspension), U-100 Patient Package Insert	PATIENT PACKAGE INSERT (updated)

Humulin R Regular (insulin human injection, USP [rDNA origin]), U-100 Patient Package Insert	PATIENT PACKAGE INSERT (updated)

Nalfon (fenoprofen calcium capsules, USP) Prescribing Information Medication Guide	MEDICATION GUIDE: Non-Steroidal Anti-Inflammatory Drugs (NSAID) Table: NSAID medicines that need a prescription Vicoprofen Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAID, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.

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