MedWatch - February 2006 Safety-Related Drug Labeling Changes

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Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2006

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS sections. Deletions or editorial revisions made to these sections are not included in this summary. The prescribing information may be accessed by clicking on the drug name.

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Abilify (aripiprazole) Tablets and Oral Solution (click product name to read prescribing information)	BOXED WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis PRECAUTIONS Use in Patients with Concomitant Illness Safety Experience in Elderly Patients with Psychosis Associated with Alzheimer's Disease	BOXED WARNING Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Abilify is not approved for the treatment of patients with dementia-related psychosis. For additional details, see MedWatch 4/11/05 Safety Alert.

Fortamet (metformin HCl extended-release tablets) (click product name to read prescribing information)	BOXED WARNING (added to sample cartons)	As with all Metformins there is a boxed warning associated with this product. Please see enclosed Full Prescribing Information including the warning regarding lactic acidosis.

Tasmar (tolcapone) Tablets (click product name to read prescribing information)	BOXED WARNING PRECAUTIONS Laboratory Tests ADVERSE REACTIONS Initial Paragraph	.....All 3 cases were reported within the first six months of initiation of treatment with Tasmar. Analysis of the laboratory monitoring data in over 3,400 Tasmar-treated patients participating in clinical trials indicated that increases in SGPT/ALT or SGOT/AST, when present, generally occurred within the first 6 months of treatment with Tasmar. Although a program of periodic laboratory monitoring for evidence of hepatocellular injury is recommended, it is not clear that periodic monitoring of liver enzymes will prevent the occurrence of fulminant liver failure..... .....In patients determined to be appropriate candidates for treatment with Tasmar, SGPT/ALT and SGOT/AST levels should be determined at baseline and periodically (i.e. every 2 to 4 weeks) for the first 6 months of therapy. After the first six months, periodic monitoring is recommended at intervals deemed clinically relevant. Although more frequent monitoring increases the chances of early detection, the precise schedule for monitoring is a matter of clinical judgement..... Tasmar should be discontinued if SGPT/ALT or SGOT/AST levels exceed 2 times5the upper limit of normal.....

Tolectin 600 (tolmetin sodium) Tablets Tolectin DS (tolemetin sodium) Capsules (click product name to read labeling template)	BOXED WARNING Cardiovascular Risk Gastrointestinal Risk CONTRAINDICATIONS WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Anaphylactoid Reactions Skin Reactions Pregnancy PRECAUTIONS General Hepatic Effects Hematological Effects Preexisting Asthma Information for Patients Laboratory Tests Drug Interactions ACE-inhibitors Aspirin Diuretics Lithium Methotrexate Warfarin Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects. Pregnancy Category C Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use MEDICATION GUIDE	Please see attached labeling template. This labeling supplement is in response to the Agency’s June 15, 2005 letter to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the labeling of all NSAIDs to provide more specific information for practitioners, patients, family members and caregivers about potential risks of CV (cardiovascular) and GI (gastrointestinal) adverse effects for patients taking NSAIDs. Additionally, the label was revised to include a description of early symptoms associated with Stevens-Johnson Syndrome. The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Wellbutrin (bupropion hydrochloride) Tablets (click product name to read prescribing information)	BOXED WARNING Suicidality in Children and Adolescents WARNINGS Clinical Worsening and Suicide Risk MEDICATION GUIDE	BOXED WARNING Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Wellbutrin or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Wellburtrin is not approved for use in pediatric patients..... WARNINGS .....In addition, patients with a history of suicidal behavior or thoughts, those patients exhibiting a significant degree of suicidal ideation prior to commencement of treatment, and young adults, are at an increased risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment..... For additional details, see MedWatch 10/15/04 Safety Alert.

Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets (click product name to read prescribing information)	BOXED WARNING Suicidality in Children and Adolescents WARNINGS Clinical Worsening and Suicide Risk MEDICATION GUIDE	BOXED WARNING Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Wellbutrin SR or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Wellbutrin SR is not approved for use in pediatric patients..... WARNINGS .....In addition, patients with a history of suicidal behavior or thoughts, those patients exhibiting a significant degree of suicidal ideation prior to commencement of treatment, and young adults, are at an increased risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment..... For additional details, see MedWatch 10/15/04 Safety Alert.

Wellbutrin XL (bupropion hydrochloride extended-release tablets) (click product name to read prescribing information)	BOXED WARNING Suicidality in Children and Adolescents WARNINGS Clinical Worsening and Suicide Risk MEDICATION GUIDE	BOXED WARNING Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Wellbutrin XL or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Wellburtrin XL is not approved for use in pediatric patients..... WARNINGS .....In addition, patients with a history of suicidal behavior or thoughts, those patients exhibiting a significant degree of suicidal ideation prior to commencement of treatment, and young adults, are at an increased risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment..... For additional details, see MedWatch 10/15/04 Safety Alert.

Zyprexa (olanzapine tablets) Zyprexa Zydis (olanzapine orally disintegrating tablets) Zyprexa IntraMuscular (olanzapine for injection) (click product name to read prescribing information)	BOXED WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis WARNINGS Increased Mortality in Elderly Patients with Dementia-Related Psychosis	BOXED WARNING Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Zyprexa (olanzapine) is not approved for the treatment of patients with dementia-related psychosis. WARNINGS Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Zyprexa is not approved for the treatment of patients with dementia-related psychosis..... For additional details, see MedWatch 4/11/05 Safety Alert.

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Paxil (paroxetine hydrochloride) Tablets and Oral Suspension (click product name to read prescribing information)	CONTRAINDICATIONS WARNINGS Usage in Pregnancy: Teratogenic Effects Animal Findings Nonteratogenic Effects PRECAUTIONS Drug Interactions Pimozide Pregnancy Category D MEDICATION GUIDE	CONTRAINDICATIONS Concomitant use in patients taking pimozide is contraindicated..... WARNINGS Usage in Pregnancy: Teratogenic Effects Epidemiological studies have shown that infants born to women who had first trimester paroxetine exposure had an increased risk of cardiovascular malformations, primarily ventricular and atrial septal defects (VSDs and ASDs)..... Animal Findings Reproduction studies were performed at doses up to 50 mg/kg/day in rats and 6 mg/kg/day in rabbits administered during organogenesis. These doses are approximately 8 (rat) and 2 (rabbit) times the MRHD on an mg/m² basis. These studies have revealed no evidence of teratogenic effects. However, in rats, there was an increase in pup deaths during the first 4 days of lactation when dosing occurred during the last trimester of gestation and continued throughout lactation..... Nonteratogenic Effects Neonates exposed to Paxil and other SSRIs or serotonin and norepinephrine reuptake inhibitors (SNRIs), late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery..... There have also been postmarketing reports of premature births in pregnant women exposed to paroxetine or other SSRIs..... For additional details, see MedWatch 12/8/05 Safety Alert.

Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets (click product name to read prescribing information)	CONTRAINDICATIONS WARNINGS Usage in Pregnancy: Teratogenic Effects Animal Findings Nonteratogenic Effects PRECAUTIONS Drug Interactions Pimozide Pregnancy Category D MEDICATION GUIDE	CONTRAINDICATIONS Concomitant use in patients taking pimozide is contraindicated..... WARNINGS Usage in Pregnancy: Teratogenic Effects Epidemiological studies have shown that infants born to women who had first trimester paroxetine exposure had an increased risk of cardiovascular malformations, primarily ventricular and atrial septal defects (VSDs and ASDs)..... Animal Findings Reproduction studies were performed at doses up to 50 mg/kg/day in rats and 6 mg/kg/day in rabbits administered during organogenesis. These doses are approximately 8 (rat) and 2 (rabbit) times the MRHD on an mg/m² basis. These studies have revealed no evidence of teratogenic effects. However, in rats, there was an increase in pup deaths during the first 4 days of lactation when dosing occurred during the last trimester of gestation and continued throughout lactation..... Nonteratogenic Effects Neonates exposed to Paxil CR and other SSRIs or serotonin and norepinephrine reuptake inhibitors (SNRIs), late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery..... There have also been postmarketing reports of premature births in pregnant women exposed to paroxetine or other SSRIs..... For additional details, see MedWatch 12/8/05 Safety Alert.

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Acetadote (acetylcysteine) Injection (for Intravenous Use) (click product name to read prescribing information)	WARNINGS PRECAUTIONS Pediatric Patients No adverse effects were noted during I.V. infusion with acetylcysteine at a mean rate of 4.2 mg/kg/h for 24 hours to 10 preterm newborns ranging in gestational age from 25 to 31 weeks.....	For specific treatment information regarding the clinical management of acetaminophen overdose, please contact your regional poison center at 1-800-222-1222, or alternatively, a special health professional assistance line for acetaminophen overdose at 1-800-525-6115.

Advil Allergy Sinus (200 mg ibuprofen/30 mg pseudoephedrine HCl/2 mg chlorpheniramine maleate) Tablets Over-the-Counter (OTC) Medication (click product name to read labeling template)	WARNINGS Allergy Alert Stomach Bleeding Warning DO NOT USE..... ASK A DOCTOR BEFORE USE IF YOU HAVE...... ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE..... WHEN USING THIS PRODUCT..... STOP USE AND ASK A DOCTOR IF..... IF PREGNANT OR BREAST-FEEDING.....	Please see attached labeling template. Revisions to the Drug Facts label and Principal Display Panel include more specific information for consumers, family members, and caregivers about potential risks of cardiovascular and gastrointestinal adverse effects associated with the use of non-prescription NSAIDS (excluding aspirin). In addition, the "Allergy Alert" has been revised to include a warning for aspirin sensitive individuals and a description of early symptoms associated with Stevens-Johnson Syndrome (SJS). The "Alcohol Warning" has been relocated to appear as part of the new "Stomach Bleeding Warning". The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Advil Cold & Sinus (200 mg ibuprofen/30 mg pseudoephedrine HCl) Tablets Over-the-Counter (OTC) Medication (click product name to read labeling template)	WARNINGS Allergy Alert Stomach Bleeding Warning DO NOT USE..... ASK A DOCTOR BEFORE USE IF YOU HAVE...... ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE..... WHEN USING THIS PRODUCT..... STOP USE AND ASK A DOCTOR IF..... IF PREGNANT OR BREAST-FEEDING.....	Please see attached labeling template. Revisions to the Drug Facts label and Principal Display Panel include more specific information for consumers, family members, and caregivers about potential risks of cardiovascular and gastrointestinal adverse effects associated with the use of non-prescription NSAIDS (excluding aspirin). In addition, the "Allergy Alert" has been revised to include a warning for aspirin sensitive individuals and a description of early symptoms associated with Stevens-Johnson Syndrome (SJS). The "Alcohol Warning" has been relocated to appear as part of the new "Stomach Bleeding Warning". The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Advil Liqui-Gels (200 mg ibuprofen capsules) Advil Migraine (200 mg ibuprofen) Capsules Over-the-Counter (OTC) Medication (click product name to read labeling template)	WARNINGS Allergy Alert Stomach Bleeding Warning DO NOT USE..... ASK A DOCTOR BEFORE USE IF YOU HAVE...... ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE..... WHEN USING THIS PRODUCT..... STOP USE AND ASK A DOCTOR IF..... IF PREGNANT OR BREAST-FEEDING.....	Please see attached labeling template. Revisions to the Drug Facts label and Principal Display Panel include more specific information for consumers, family members, and caregivers about potential risks of cardiovascular and gastrointestinal adverse effects associated with the use of non-prescription NSAIDS (excluding aspirin). In addition, the "Allergy Alert" has been revised to include a warning for aspirin sensitive individuals and a description of early symptoms associated with Stevens-Johnson Syndrome (SJS). The "Alcohol Warning" has been relocated to appear as part of the new "Stomach Bleeding Warning". The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Children’s Motrin (50 mg ibuprofen) Chewable Tablets Motrin Junior Strength (100 mg ibuprofen) Chewable Tablets Over-the-Counter (OTC) Medication (click product name to read labeling template)	WARNINGS Allergy Alert Stomach Bleeding Warning Sore Throat Warning DO NOT USE..... ASK A DOCTOR BEFORE USE IF THE CHILD HAS ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS..... WHEN USING THIS PRODUCT..... STOP USE AND ASK A DOCTOR.....	Please see attached labeling template. Revisions to the Drug Facts label and Principal Display Panel include more specific information for consumers, family members, and caregivers about potential risks of cardiovascular and gastrointestinal adverse effects associated with the use of non-prescription NSAIDS (excluding aspirin). In addition, the "Allergy Alert" has been revised to include a warning for aspirin sensitive individuals and a description of early symptoms associated with Stevens-Johnson Syndrome (SJS). The "Alcohol Warning" has been relocated to appear as part of the new "Stomach Bleeding Warning". The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Effexor (venlafaxine hydrochloride) Tablets (click product name to read prescribing information)	WARNINGS Mydriasis PRECAUTIONS Information for Patients Mydriasis ADVERSE REACTIONS Postmarketing Reports Angle-closure Glaucoma	Mydriasis has been reported in association with venlafaxine; therefore patients with raised intraocular pressure or at risk of acute narrow-angle glaucoma (angle-closure glaucoma) should be monitored.

Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules (click product name to read prescribing information)	WARNINGS Mydriasis PRECAUTIONS Information for Patients Mydriasis ADVERSE REACTIONS Postmarketing Reports Angle-closure Glaucoma	Mydriasis has been reported in association with venlafaxine; therefore patients with raised intraocular pressure or at risk of acute narrow-angle glaucoma (angle-closure glaucoma) should be monitored.

Junior Strength Motrin (100 mg ibuprofen) Tablets Over-the-Counter (OTC) Medication (click product name to read labeling template)	WARNINGS Allergy Alert Stomach Bleeding Warning Sore Throat Warning DO NOT USE..... ASK A DOCTOR BEFORE USE IF THE CHILD HAS...... ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS..... WHEN USING THIS PRODUCT..... STOP USE AND ASK A DOCTOR IF.....	Please see attached labeling template. Revisions to the Drug Facts label and Principal Display Panel include more specific information for consumers, family members, and caregivers about potential risks of cardiovascular and gastrointestinal adverse effects associated with the use of non-prescription NSAIDS (excluding aspirin). In addition, the "Allergy Alert" has been revised to include a warning for aspirin sensitive individuals and a description of early symptoms associated with Stevens-Johnson Syndrome (SJS). The "Alcohol Warning" has been relocated to appear as part of the new "Stomach Bleeding Warning". The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Motrin Cold & Sinus (200 mg ibuprofen/30 mg pseudoephedrine HCl) Tablets Over-the-Counter (OTC) Medication (click product name to read labeling template)	WARNINGS Allergy Alert Stomach Bleeding Warning DO NOT USE..... ASK A DOCTOR BEFORE USE IF YOU HAVE...... ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE..... WHEN USING THIS PRODUCT..... STOP USE AND ASK A DOCTOR IF..... IF PREGNANT OR BREAST-FEEDING.....	Please see attached labeling template. Revisions to the Drug Facts label and Principal Display Panel include more specific information for consumers, family members, and caregivers about potential risks of cardiovascular and gastrointestinal adverse effects associated with the use of non-prescription NSAIDS (excluding aspirin). In addition, the "Allergy Alert" has been revised to include a warning for aspirin sensitive individuals and a description of early symptoms associated with Stevens-Johnson Syndrome (SJS). The "Alcohol Warning" has been relocated to appear as part of the new "Stomach Bleeding Warning". The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Motrin IB (200 mg ibuprofen) Tablets Motrin Migraine Pain (200 mg ibuprofen) Tablets Over-the-Counter (OTC) Medication (click product name to read labeling template)	WARNINGS Allergy Alert Stomach Bleeding Warning DO NOT USE..... ASK A DOCTOR BEFORE USE IF YOU HAVE...... ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE..... WHEN USING THIS PRODUCT..... STOP USE AND ASK A DOCTOR IF..... IF PREGNANT OR BREAST-FEEDING.....	Please see attached labeling template. Revisions to the Drug Facts label and Principal Display Panel include more specific information for consumers, family members, and caregivers about potential risks of cardiovascular and gastrointestinal adverse effects associated with the use of non-prescription NSAIDS (excluding aspirin). In addition, the "Allergy Alert" has been revised to include a warning for aspirin sensitive individuals and a description of early symptoms associated with Stevens-Johnson Syndrome (SJS). The "Alcohol Warning" has been relocated to appear as part of the new "Stomach Bleeding Warning". The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Motrin Infants’ Drops* (50 mg/1.25 mL ibuprofen oral suspension) *Berry (¼ and ½ oz) and Dye-free Berry- (½ and 1 oz) flavored package sizes Over-the-Counter (OTC) Medication (click product name to read labeling template)	WARNINGS Allergy Alert Stomach Bleeding Warning Sore Throat Warning DO NOT USE..... ASK A DOCTOR BEFORE USE IF THE CHILD HAS...... ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS..... WHEN USING THIS PRODUCT..... STOP USE AND ASK A DOCTOR IF.....	Please see attached labeling template. Revisions to the Drug Facts label and Principal Display Panel include more specific information for consumers, family members, and caregivers about potential risks of cardiovascular and gastrointestinal adverse effects associated with the use of non-prescription NSAIDS (excluding aspirin). In addition, the "Allergy Alert" has been revised to include a warning for aspirin sensitive individuals and a description of early symptoms associated with Stevens-Johnson Syndrome (SJS). The "Alcohol Warning" has been relocated to appear as part of the new "Stomach Bleeding Warning". The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Rituxan (rituximab) (click product name to read prescribing information) Note: In February 2006, two new indications were approved for Rituxan (rituximab). This label includes Rituxan's new indication for first-line treatment of diffuse large B-cell, CD20-positive, non-Hodgkin's lymphoma in combination with CHOP or other anthracycline-based chemotherapy regimens.	WARNINGS Hepatitis B Reactivation with Related Fulminant Hepatitis and Other Viral Infections Severe Mucocutaneous Reactions PRECAUTIONS Geriatric Use ADVERSE REACTIONS The overall safety database for Rituxan is based on clinical trial data..... The following serious adverse reactions, some with fatal outcomes, have..... Except as noted, adverse events described below occurred in the setting of..... Immunogenicity Single Agent Rituxan for Relapsed or Refractory, Low‑Grade or Follicular, CD20‑Positive, B‑Cell, NHL Risk Factors Associated with Increased Rates of Adverse Events Rituxan in Combination with Chemotherapy for DLBCL	Hepatitis B Reactivation with Related Fulminant Hepatitis and Other Viral Infections The following additional serious viral infections, either new, reactivated or exacerbated, have been identified in clinical studies or postmarketing reports. The majority of patients received Rituxan in combination with chemotherapy or as part of a hematopoietic stem cell transplant. These viral infections included JC virus [progressive multifocal leukoencephalopathy (PML)], cytomegalovirus, herpes simplex virus, parvovirus B19, varicella zoster virus, West Nile virus, and hepatitis C..... Severe Mucocutaneous Reactions .....These reports include paraneoplastic pemphigus (an uncommon disorder which is a manifestation of the patient’s underlying malignancy).....

Rituxan (rituximab) (click product name to read prescribing information) Note: In February 2006, two new indications were approved for Rituxan (rituximab). This label includes the indication for Rituxan in combination with methotrexate to reduce signs and symptoms in adult patients with moderately- to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF antagnoist therapies.	WARNINGS Severe Infusion Reactions Management of Severe Infusion Reactions Hypersensitivity Reactions Concomitant use with biologic agents and DMARDs other than Methotrexate in RA PRECAUTIONS Drug/Laboratory Interactions Immunization Use in Patients with RA Who Had No Prior Inadequate Response to TNF Antagonists Retreatment in Patients with RA Geriatric Use ADVERSE REACTIONS Adverse Reactions in Patients with Rheumatoid Arthritis Table 7: Incidence of All Adverse Events Occurring in ≥2% and at least 1% greater than placebo among Rheumatoid Arthritis Patients..... Infusion Reactions Infections Cardiac Events Immunogenicity PATIENT PACKAGE INSERT	Severe Infusion Reactions The following signs and symptoms were added: Urticaria Anaphylactic and Anaphylactoid Events Management of Severe Infusion Reactions Medications and supportive care measures including, but not limited to, epinephrine, antihistamines, glucocorticoids, intravenous fluids, vasopressors, oxygen, bronchodilators, and acetaminophen, should be available and instituted as medically indicated for use in the event of a reaction during administration. Hypersensitivity Reactions Glucocorticoids added as a medication for the treatment of hypersensitivity reactions. Concomitant use with biologic agents and DMARDs other than Methotrexate in RA Limited data are available on the safety of the use of biologic agents or DMARDs other than methotrexate in patients exhibiting peripheral B cell depletion following treatment with rituximab. Patients should be closely observed for signs of infection if biologic agents and/or DMARDs are used concomitantly.

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Brand (Generic) Name	Sections Modified
Astelin (azelastine hydrochloride) Nasal Spray (click product name to read prescribing information)	PRECAUTIONS Activities Requiring Mental Alertness ADVERSE REACTIONS Seasonal Allergic Rhinitis Initial Section & Table Dermatological Skin Laceration Digestive Diarrhea Toothache Musculoskeletal Rheumatoid Arthritis Respiratory Bronchitis Dry Throat Nocturnal Dyspnea Nasopharyngitis Nasal Congestion Pharyngolaryngeal Pain Sinusitis Nasal Dryness Paranasal Sinus Hypersecretion Post Nasal Drip Whole Body Pyrexia

Betaxolol hydrochloride ophthalmic solution, 0.5% as base (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Cardura (doxazosin mesylate) Tablets (click product name to read prescribing information)	PRECAUTIONS Cataract Surgery Intraoperative Floppy Iris Syndrome (IFIS) Geriatric Use ADVERSE REACTIONS In the postmarketing experience.... Special Senses Intraoperative Floppy Iris Syndrome

Ceredase (alglucerase injection) (click product name to read prescribing information)	PRECAUTIONS Pediatric Use

Cystadane (betaine anhydrous for oral solution) (click product name to read prescribing information)	PRECAUTIONS Hypermethioninemia ADVERSE REACTIONS A few cases of cerebral edema have been reported.....

Famvir (famciclovir) Tablets (click product name to read prescribing information)	PRECAUTIONS General Famvir 125 mg, 250 mg and 500 mg tablets contain lactose..... Information for Patients There is no evidence that Famvir will affect the ability of a patient to drive or to use machines. ADVERSE REACTIONS Postmarketing Experience Serious Skin Reactions (e.g. Erythema Multiforme) Jaundice Thrombocytopenia Dizziness Somnolence

Flovent HFA (fluticasone propionate) Inhalation Aerosol (click product name to read prescribing information)	PRECAUTIONS Pediatric Use ADVERSE REACTIONS Pediatric Patients

Hytrin (terazosin hydrochloride) Capsules (click product name to read prescribing information)	PRECAUTIONS General Intraoperative Floppy Iris Syndrome (IFIS) ADVERSE REACTIONS Postmarketing Experience During cataract surgery, a variant of small pupil syndrome known as Intraoperative Floppy Iris Syndrome (IFIS).....

Hytrin (terazosin hydrochloride) Tablets (click product name to read prescribing information)	PRECAUTIONS General Intraoperative Floppy Iris Syndrome (IFIS) ADVERSE REACTIONS Postmarketing Experience During cataract surgery, a variant of small pupil syndrome known as Intraoperative Floppy Iris Syndrome (IFIS)....

Lasix (furosemide) Tablets (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Nexium (esomeprazole magnesium) Delayed-Release Capsules (click product name to read prescribing information)	PRECAUTIONS Drug Interactions Atazanavir ADVERSE REACTIONS Postmarketing Reports Blood and Lymphatic System Disorders Agranulocytosis Pancytopenia Eye Disorders Blurred Vision Immune System Disorders Anaphylactic Reaction/Shock Psychiatric Disorders Depression Skin and Subcutaneous Tissue Disorders Alopecia

Nexium I.V. (esomeprazole sodium) for Injection (click product name to read prescribing information)	PRECAUTIONS Drug Interactions Atazanavir ADVERSE REACTIONS Postmarketing Reports Blood and Lymphatic System Disorders Agranulocytosis Pancytopenia Eye Disorders Blurred Vision Immune System Disorders Anaphylactic Reaction/Shock Psychiatric Disorders Depression Skin and Subcutaneous Tissue Disorders Alopecia

Zegerid (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension (click product name to read prescribing information)	PRECAUTIONS General Information for Patients ADVERSE REACTIONS A controlled clinical trial was conducted in 359 critically ill patients, comparing Zegerid 40 mg/1680 mg suspension..... [paragraph after Table 12]

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Brand (Generic) Name	Sections Modified
FazaClo (clozapine, USP) Orally Disintegrating Tablets (click product name to read prescribing information)	ADVERSE REACTIONS Postmarketing Clinical Experience Metabolic and Nutritional Disorders Hypercholesterolemia (very rare) Hypertriglyceridemia (very rare)

1.5% Glycine Irrigation, USP (click product name to read prescribing information)	ADVERSE REACTIONS Transient Blindness Overdosage

Imitrex (sumatriptan succinate) Injection (click product name to read prescribing information)	ADVERSE REACTIONS Incidence in Controlled Clinical Trials of Migraine Headache Table 4: Treatment-Emergent Adverse Experience Incidence in 2 Large Placebo-Controlled Migraine Clinical Trials..... Other Events Observed in Association With the Administration of Imitrex Injection Eye Vision Alterations Gastrointestinal Abdominal discomfort Dysphagia Musculoskeletal Muscle Cramps Neurological Anxiety PATIENT PACKAGE INSERT

Indocin I.V. (indomethacin sodium trihydrate) (click product name to read prescribing information)	ADVERSE REACTIONS Gastrointestinal Gastric Perforation

Lupron (leuprolide acetate) Injection (for pediatric use) (click product name to read prescribing information)	ADVERSE REACTIONS Postmarketing Pituitary Apoplexy

Lupron Depot-Ped (leuprolide acetate for depot suspension) (click product name to read prescribing information)	ADVERSE REACTIONS Postmarketing Pituitary Apoplexy

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