MedWatch - July 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) -- July 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
Anafranil (clomipramine hydrochloride 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 clomipramine hydrochloride. MEDICATION GUIDE (updated) "Antidepressant Medications, 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 clomipramine hydrochloride 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.

Baraclude (entecavir) Tablets and Oral Solution Prescribing Information Patient Package Insert See MedWatch Safety Alert posted 08/16/2007 for additional information on Baraclude labeling revisions.	BOXED WARNING WARNINGS Co-infection with HIV PRECAUTIONS Information for Patients Patients should be offered HIV antibody testing before starting Baraclude therapy. They should be informed that if they have HIV infection and are not receiving effective HIV treatment, Baraclude may increase the chance of HIV resistance to HIV medication (see WARNINGS: Co-infection with HIV). PATIENT PACKAGE INSERT If you have or get HIV (human immunodeficiency virus) infection be sure to discuss your treatment with your doctor...	BOXED WARNING ...Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if Baraclude is used to treat chronic hepatitis B virus infection in patients with HIV infection that is not being treated. Therapy with Barclude is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART)... WARNINGS: Co-infection with HIV Baraclude has not been evaluated in HIV/HBV co-infected patients who were not simultaneously receiving effective HIV treatment. Limited clinical experience suggests there is a potential for the development of resistance to HIV nucleoside reverse transcriptase inhibitors if Barclude is used to treat chronic hepatitis B virus infection in patients with HIV infection that is not being treated. Therefore, therapy with Baraclude is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART). Before initiating Baraclude therapy, HIV antibody testing should be offered to all patients. Baraclude has not been studied as a treatment for HIV infection and is not recommended for this use.

Emsam (selegiline transdermal system) Continuous Delivery for Once-Daily Application 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 Emsam. MEDICATION GUIDE (updated) "Antidepressant Medications, 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 Emsam 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.

EstroGel 0.06% (estradiol gel) Prescribing Information Patient Package Insert	BOXED WARNING Cardiovascular and Other Risks WARNINGS Cardiovascular Disorders Stroke Coronary Heart Disease Venous Thromboembolism (VTE) Malignant Neoplasms Endometrial Cancer Breast Cancer Dementia PRECAUTIONS General Ovarian Cancer Geriatric Use ADVERSE REACTIONS Miscellaneous Arthralgias Urticaria Angioedema PATIENT PACKAGE INSERT What is the most important information I should know about EstroGel (An Estrogen Hormone)? What are the possible adverse events of estrogens? What can I do to lower my chances of having an adverse event with EstroGel? General information about the safe and effective use of EstroGel	BOXED WARNING: Cardiovascular and Other Risks The estrogen-alone substudy of the Women's Health Initiative (WHI) reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (aged 50-79 years) during 6.8 and 7.1 years, respectively, of treatment with oral conjugated estrogens (CE 0.625 mg) per day, relative to placebo... The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with CE 0.625 mg alone and during 4 years of treatment with CE 0.625 mg combined with MPA 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women... WARNINGS See highlighted prescribing information for revised text.

Norpramin (desipramine hydrochloride 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 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 Norpramin. MEDICATION GUIDE (updated) "Antidepressant Medications, 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 Norpramin 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.

Nortriptyline Hydrochloride Oral Solution, 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 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 nortriptyline hydrochloride. MEDICATION GUIDE (updated) "Antidepressant Medications, 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 Nortriptyline Hydrochloride Oral Solution 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.

Pamelor (nortriptyline HCl) Capsules and Oral Solution, 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 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 nortriptyline hydrochloride. MEDICATION GUIDE (updated) "Antidepressant Medications, 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 nortriptyline hydrochloride 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.

Remeron (mirtazapine) 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 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 Remeron. MEDICATION GUIDE (updated) "Antidepressant Medications, 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 Remeron (mirtazapine) 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.

RemeronSolTab (mirtazapine) Orally Disintegrating 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 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 RemeronSolTab. MEDICATION GUIDE (updated) "Antidepressant Medications, 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 RemeronSolTab (mirtazapine) Orally Disintegrating 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.

Seroquel (quetiapine fumarate) 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 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 Seroquel. MEDICATION GUIDE (updated) "Antidepressant Medications, 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 Seroquel 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.

Tofranil-PM (imipramine pamoate 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 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 imipramine pamoate. MEDICATION GUIDE (updated) "Antidepressant Medications, 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 imipramine pamoate 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.

Xolair (omalizumab) for Subcutaneous Use Prescribing Information Medication Guide See MedWatch Safety Alert posted 07/02/2007 for additional information on Xolair labeling revisions and information for healthcare professionals.	BOXED WARNING WARNINGS Anaphylaxis PRECAUTIONS Information for Patients Pregnancy Exposure Registry ADVERSE REACTIONS Clinical Trials Experience Initial Section Postmarketing Spontaneous Reports MEDICATION GUIDE (new)	BOXED WARNING Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of Xolair. Anaphylaxis has occurred as early as after the first dose of Xolair, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, patients should be closely observed for an appropriate period of time after Xolair administration, and health care providers administering Xolair should be prepared to manage anaphylaxis that can be life-threatening. Patients should also be informed of the signs and symptoms of anaphylaxis and instructed to seek immediate medical care should symptoms occur... WARNINGS: Anaphylaxis See highlighted prescribing information for revised text.

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Aygestin (norethindrone acetate tablets, USP) Prescribing Information Patient Package Insert	CONTRAINDICATIONS WARNINGS Cardiovascular Disorders PRECAUTIONS Drug/Laboratory Tests Interactions Nursing Mothers Pediatric Use ADVERSE REACTIONS Initial Section Changes in the cervical squamo-columnar junction... PATIENT PACKAGE INSERT (rewritten)	CONTRAINDICATIONS See highlighted prescribing information for revised text. WARNINGS: Cardiovascular Disorders Patients with risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately.

Dipentum (olsalazine sodium capsules) Prescribing Information	CONTRAINDICATIONS PRECAUTIONS Drug Interactions Co-administration of salicylates and low molecular weight heparins or heparinoids... Co-administration of olsalazine and 6-mercaptopurine or thioguanine may result in an increased risk of myelosuppression... It is recommended not to give salicylates for six weeks after the varicella vaccine to avoid a possible increased risk of developing Reye's syndrome. Carcinogenesis, Mutagenesis, Impairment of Fertility Nursing Mothers Severe Allergies and/or Asthma Renal Hepatic ADVERSE REACTIONS Table 2 Cardiac Disorders Myocarditis Gastrointestinal Disorders Abdominal Pain (upper) Renal and Urinary Disorders Urinary Frequency Postmarketing Experience Blood and Lymphatic System Disorders General Disorders and Administration Site Conditions Hepatobiliary Disorders Musculoskeletal and Connective Tissue Disorders Respiratory, Thoracic and Mediastinal Disorders Skin and Subcutaneous Tissue Disorders Nervous System Disorders Renal and Urinary Disorders	CONTRAINDICATIONS Hypersensitivity to olsalazine, other salicylates, or any of the excipients.

Intron A (interferon alfa-2b, recombinant) for Injection Prescribing Information Medication Guides: Intron A Powder for Injection Intron A Solution for Injection Intron A Multidose Pen for Injection	CONTRAINDICATIONS Intron A and Rebetol Combination Therapy WARNINGS Neuropsychiatric Disorders PRECAUTIONS Dental and Periodontal Disorders Pregnancy Category X Ribavirin Pregnancy Registry ADVERSE REACTIONS Postmarketing Experience ...Stevens Johnson Syndrome Toxic Epidermal Necrolysis Erythema Multiforme Injection Site Necrosis Myositis Hearing Loss ...Autoimmune and immune-mediated disorders... Idiopathic Thrombocytopenic Purpura Thrombotic Thrombocytopenic Purpura MEDICATION GUIDE What is the most important information I should know about Intron A? What should I avoid while taking Intron A?	CONTRAINDICATIONS Intron A and Rebetol combination therapy is additionally contraindicated in: Patients with creatinine clearance < 50 mL/min (added to list) WARNINGS: Neuropsychiatric Disorders Depression and suicidal behavior including suicidal ideation, suicidal attempts, and completed suicides, and aggressive behavior, sometimes directed towards others, have been reported in association with treatment with alfa interferons, including, Intron A therapy. If patients develop psychiatric problems, including clinical depression, it is recommended that the patients be carefully monitored during treatment and in the 6-month follow-up period... ...If psychiatric symptoms persist or worsen, or suicidal ideation or aggressive behavior towards others is identified, it is recommended that treatment with Intron A be discontinued and the patient followed, with psychiatric intervention as appropriate. ...Cases of encephalopathy have also been observed in some patients, usually elderly, treated with higher doses of Intron A.

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Ceftin Tablets (cefuroxime axetil tablets) Ceftin for Oral Suspension (cefuroxime axetil powder for oral suspension) Prescribing Information	WARNINGS PRECAUTIONS 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.

Crestor (rosuvastatin calcium) Tablets Prescribing Information	WARNINGS Myopathy/Rhabdomyolysis PRECAUTIONS Drug Interactions Lopinavir/Ritonavir ADVERSE REACTIONS Postmarketing Experience Memory Loss	WARNINGS: Myopathy/Rhabdomyolysis The risk of myopathy during treatment with rosuvastatin may be increased with concurrent administration of other lipid-lowering therapies, cyclosporine, or lopinavir/ritonavir...

Evista (raloxifene hydrochloride) Tablets Prescribing Information (in new labeling format) Patient Package Insert	WARNINGS & PRECAUTIONS Cardiovascular Disease Death Due to Stroke Renal Impairment PATIENT PACKAGE INSERT What is the most important information I should know about Evista? What is Evista? What should I tell my doctor before taking Evista? What are the possible side effects of Evista? What else should I know about Evista? How should I store Evista? General information about the safe and effective use of Evista. What are the ingredients in Evista?	WARNINGS & PRECAUTIONS Cardiovascular Disease Evista should not be used for the primary or secondary prevention of cardiovascular disease. In a clinical trial of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, no cardiovascular benefit was demonstrated after treatment with raloxifene for 5 years... Death Due to Stroke In a clinical trial of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, an increased risk of death due to stroke was observed after treatment with Evista. During an average follow-up of 5.6 years, 59 (1.2%) Evista-treated women died due to a stroke compared to 39 (0.8%) placebo-treated women (22 versus 15 per 10,000 women-years; hazard ratio 1.49; 95% confidence interval, 1.00 - 2.24; p=0.0499). There was no statistically significant difference between treatment groups in the incidence of stroke (249 in Evista [4.9%] versus 224 placebo [4.4%]). Evista had no significant effect on all-cause mortality. The risk-benefit balance should be considered in women at risk for stroke, such as prior stroke or transient ischemic attack (TIA), atrial fibrillation, hypertension, or cigarette smoking... Renal Impairment Evista should be used with caution in patients with moderate or severe renal impairment. Safety and efficacy have not been established in patients with moderate or severe renal impairment...

Fortaz (ceftazidime for injection) Fortaz (ceftazidime injection) For Intravenous or Intramuscular Use 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 2 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 Fortaz, 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.

Invirase (saquinavir mesylate) Capsules and Tablets Prescribing Information Patient Package Insert	WARNINGS Interaction with Digoxin PRECAUTIONS Drug Interactions Table 6 Other Agents Digitalis Glycosides Digoxin PATIENT PACKAGE INSERT Are there other medications that I should not take with Invirase/Norvir (ritonavir)?	WARNINGS Caution should be exercised when Invirase and digoxin are coadministered; serum concentration of digoxin should be monitored and the dose of digoxin may need to be reduced...

Neulasta (pegfilgrastim) Prescribing Information Patient Package Insert	WARNINGS Splenic Rupture Acute Respiratory Distress Syndrome (ARDS) ADVERSE REACTIONS Immunogenicity Initial Paragraph PATIENT PACKGE INSERT What is Neulasta used for? How does Neulasta work? What important infomation do I need to know about receiving Neulasta? What are the possible serious side effects of Neulasta?	WARNINGS: Splenic Rupture Splenic rupture, including fatal cases, has been reported following the administration of Neulasta and its parent compound, Filgrastim. Patients receiving Neulasta who report left upper abdominal and/or shoulder tip pain should be evaluated for an enlarged spleen or splenic rupture. WARNINGS: Acute Respiratory Distress Syndrome (ARDS) Acute respiratory distress syndrome (ARDS) has been reported in patients receiving Neulasta, and is postulated to be secondary to an influx of neutrophils to sites of inflammation in the lungs. Patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS...

Rocephin (ceftriaxone sodium) for injection 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.	Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Rocephin, 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 C. difficile, and surgical evaluation should be instituted as clinically indicated.

Viracept (nelfinavir mesylate) Tablets and Oral Powder Prescribing Information	WARNINGS Drug Interactions PDE5 Inhibitors PRECAUTIONS General Nelfinavir is principally metabolized by the liver... Information for Patients PDE5 Inhibitors Drug Interactions Table 11 Other Agents PDE5 Inhibitors	WARNINGS: Drug Interactions Particular caution should be used when prescribing sildenafil, or other PDE5 inhibitors, in patients receiving protease inhibitors, including Viracept. Coadministration of these drugs is expected to substantially increase PDE5 inhibitor concentrations and may result in an increase in PDE5 inhibitor-associated adverse events, including hypotension, visual changes, and priapism...

Zestoretic (lisinopril and hydrochlorothiazide) Prescribing Information	WARNINGS Pregnancy Lisinopril Fetal/Neonatal Morbidity and Mortality PRECAUTIONS Pregnancy Female patients of childbearing age should be told about the consequences of exposure to ACE inhibitors during pregnancy. These patients should be asked to report pregnancies to their physicians as soon as possible.	WARNINGS: Lisinopril/Fetal/Neonatal Morbidity and Mortality ...In a published retrospective epidemiological study, infants whose mothers had taken an ACE inhibitor during the first trimester of pregnancy appeared to have an increased risk of major congenital malformations compared with infants whose mothers had not undergone first trimester exposure to ACE inhibitor drugs. The number of cases of birth defects is small and the findings of this study have not yet been repeated...

Zestril (lisinopril) Prescribing Information	WARNINGS Fetal/Neonatal Morbidity and Mortality PRECAUTIONS Pregnancy Female patients of childbearing age should be told about the consequences of exposure to ACE inhibitors during pregnancy. These patients should be asked to report pregnancies to their physicians as soon as possible.	WARNINGS: Fetal/Neonatal Morbidity and Mortality ...In a published retrospective epidemiological study, infants whose mothers had taken an ACE inhibitor during the first trimester of pregnancy appeared to have an increased risk of major congenital malformations compared with infants whose mothers had not undergone first trimester exposure to ACE inhibitor drugs. The number of cases of birth defects is small and the findings of this study have not yet been repeated...

Zinacef (cefuroxime for injection) Zinacef (cefuroxime injection) 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 Zinacef, 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.

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Brand (Generic) Name	Sections Modified
Clarinex-D 12 Hour Extended Release Tablet (desloratadine and pseudoephedrine sulfate, USP) Prescribing Information	PRECAUTIONS Information for Patients Clarinex-D 12 Hour Extended Release Tablets should generally be avoided in patients with hepatic impairment and in patients with renal impairment.

Delatestryl (testosterone enanthate Injection, USP) Prescribing Information	PRECAUTIONS Intramuscular Administration When properly given, injections of Delatestryl are well tolerated. Care should be taken to slowly inject the preparation deeply into the gluteal muscle, being sure to follow the usual precautions for intramuscular administration, such as the avoidance of intravascular injection. There have been rare postmarketing reports of transient reactions involving urge to cough, coughing fits, and respiratory distress immediately after the injection of Delatestryl, an oil-based depot preparation...

Humalog (insulin lispro [rDNA origin] injection) 100 Units/mL Prescribing Information Patient Package Insert	PRECAUTIONS Information for Patients For Patients Using Pen Delivery Devices Drug Interactions Mixing of Insulins The cartridge containing Humalog is not designed to allow any other insulin to be mixed in the cartridge, for the Humalog in the cartridge to be diluted of for the cartridge to be refilled with insulin. Humalog should not be diluted or mixed with any other insulin when used in an external insulin pump. PATIENT PACKAGE INSERT (references to the HumaPen Luxura HD insulin delivery device added.)

Kaletra (lopinavir/ritonavir) Capsules and Oral Solution Prescribing Information	PRECAUTIONS Drug Interactions Table 11 HIV-Protease Inhibitor Tipranavir

Norvir (ritonavir capsules) Soft Gelatin and (ritonavir oral solution) Prescribing Information	PRECAUTIONS Drug Interactions Table 6 Other Agents HMG-CoA Reductase Inhibitor Rosuvastatin

Serostim (somatropin [rDNA origin] for injection) Prescribing Information	PRECAUTIONS General There are limited data in women with HIV-Associated Adipose Redistribution Syndrome (HARS), especially those taking estrogen... HIV and Growth Hormone Considerations ...None of the Serostim-treated HARS study participants with available test results developed detectable antibodies to rhGH during the induction or maintenance phases of treatment. In HARS patients who had normal fasting glucose levels at screening... During safety surveillance of patients with HIV-associated wasting and HARS, cases of new onset impaired glucose intolerance, new onset type 2 diabetes mellitus and exacerbation of preexisting diabetes mellitus have been reported in patients receiving Serostim... Drug Interactions ...Published in vitro data indicate that growth hormone may be an inducer of cytochrome P450 3A4... Somatropin inhibits 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) in adipose/hepatic tissue and may significantly impact the metabolism of cortisol and cortisone... ADVERSE REACTIONS HIV-Associated Adipose Redistribution Syndrome (HARS) Table 8 Glucose-Related Terms Breast-Related Terms

Toprol XL (metoprolol succinate) Extended-Release Tablets Prescribing Information	PRECAUTIONS Pediatric Use

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Brand (Generic) Name	Sections Modified
Calcijex (calcitriol injection) Prescribing Information	ADVERSE REACTIONS Postmarketing Experience Rare cases of hypersensitivity reactions have been reported, including anaphylaxis.

Crixivan (indinavir sulfate) Capsules Prescribing Information	ADVERSE REACTIONS Postmarketing Experience Urogenital System Renal Failure

Humira (adalimumab) Solution for Subcutaneous Injection Prescribing Information (in new labeling format)	ADVERSE REACTIONS Postmarketing Experience Skin Reactions Erythema Multiforme

Ovidrel (choriogonadotropin alfa injection) for Subcutaneous Use Prescribing Information	ADVERSE REACTIONS Postmarketing Reports Isolated cases of allergic reactions, manifesting mainly as mild reversible skin rashes...

VESIcare (solifenacin succinate) Tablets Prescribing Information	ADVERSE REACTIONS Postmarketing Surveillance Central Nervous Hallucinations

Zyprexa (olanzapine tablets) Zyprexa Zydis (olanzapine orally disintegrating tablets) Zyprexa IntraMuscular (olanzapine for injection) Prescribing Information	ADVERSE REACTIONS Dose Dependency of Adverse Events in Short-Term, Placebo-Controlled Trials Additional Findings Postintroduction Reports Neutropenia

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Brand (Generic) Name	Sections Modified
Actonel (risedronate sodium) Tablet, Film Coated Prescribing Information Patient Package Insert	PATIENT PACKAGE INSERT What are the ingredients of Actonel?

Daypro Alta (oxaprozin potassium) Tablets Prescribing Information Medication Guide	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.

Feldene (piroxicam) Capsules Prescribing Information Medication Guide	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.

Oruvail Extended-Release (ketoprofen extended-release) Capsule Orudis (ketoprofen) Capsule Prescribing Information Medication Guide	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.

Voltaren (diclofenac sodium enteric-coated tablets) Prescribing Information Medication Guide	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.

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