MedWatch - September 2006 Safety-Related Drug Labeling Changes

HHS Log--links to Department of Health and Human Services website

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

Summary View

Brand (Generic) Name

Sections Modified

Summary of Changes to Contraindications and Warnings

Seroquel (quetiapine fumarate) Tablets

(click product name to read prescribing information)

BOXED WARNING (new)

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. Seroquel (quetiapine) 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. Seroquel (quetiapine) is not approved for the treatment of patients with dementia-related psychosis.

Back to Summary Page

Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Cordarone (amiodarone HCl) Tablets (click product name to read prescribing information)	CONTRAINDICATIONS WARNINGS Pulmonary Toxicity PRECAUTIONS Thyroid Abnormalities There have been post-marketing reports of thyroid nodules/thyroid cancer in patients treated with Cordarone. In some instances hyperthyroidism was also present. Surgery Corneal Refractive Laser Surgery Patients should be advised that most manufacturers of corneal refractive laser surgery devices contraindicate that procedure in patients taking Cordarone. Drug Interactions Histamine H₁ Antagonists Loratadine Antidepressants Trazodone Anticoagulants Clopidogrel ADVERSE REACTIONS Post-marketing Reports MEDICATION GUIDE	CONTRAINDICATIONS Cordarone is contraindicated in patients with cardiogenic shock. WARNINGS/Pulmonary Toxicity .....Findings have included pulmonary infiltrates and/or mass on X-ray, bronchospasm, wheezing, fever, dyspnea, cough, hemoptysis, and hypoxia.....

Lopressor (metoprolol tartrate tablets and injection, USP) (click product name to read prescribing information)	CONTRAINDICATIONS Hypertension and Angina WARNINGS Hypertension and Angina Pheochromocytoma PRECAUTIONS Drug Interactions General Anesthetics Some inhalation anesthetics may enhance the cardiodepressant effect of beta-blockers. CYP2D6 Inhibitors Clonidine ADVERSE REACTIONS Hypertension and Angina Cardiovascular Gangrene in patients with pre-existing severe peripheral circulatory disorders has also been reported very rarely. Respiratory Rhinitis has also been reported. Gastrointestinal Vomiting was a common occurrence. Hypersensitivity Reactions Very rarely, photosensitivity and worsening of psoriasis has been reported. Miscellaneous .....There have been very rare reports of weight gain, arthritis, and retroperitoneal fibrosis (relationship to Lopressor has not been definitely established).	CONTRAINDICATIONS Hypersensitivity to Lopressor and related derivatives, or to any of the excipients; hypersensitivity to other beta-blockers (cross sensitivity between beta-blockers can occur). Sick-sinus syndrome. Severe peripheral arterial circulatory disorders. Pheochromocytoma. WARNINGS/Hypertension and AnginaPheochromocytoma: In patients known to have, or suspected of having, a pheochromocytoma, Lopressor is contraindicated. If Lopressor is required, it should be given in combination with an alpha blocker, and only after the alpha blocker has been initiated. Administration of beta blockers alone in the setting of pheochromocytoma have been associated with a paradoxical increase in blood pressure due to the attenuation of beta-mediated vasodilatation in skeletal muscle.

Lopressor HCT (metoprolol tartrate, USP and hydrochlorothiazide, USP) Tablets (click product name to read prescribing information)	CONTRAINDICATIONS Lopressor WARNINGS Lopressor Pheochromocytoma PRECAUTIONS Information for Patients Patients should be advised (1) to avoid operating automobiles and machinery or engaging in other tasks requiring alertness until the patient's response to therapy with Lopressor HCT has been determined; (2) to contact the physician if any difficulty in breathing occurs; (3) to inform the physician or dentist before any type of surgery that he or she is taking Lopressor HCT. Drug/Drug Interactions Lopressor General Anesthetics Some inhalation anesthetics may enhance the cardiodepressant effect of beta-blockers. CYP2D6 Inhibitors Clonidine ADVERSE REACTIONS Lopressor Cardiovascular Gangrene in patients with pre-existing severe peripheral circulatory disorders has also been reported very rarely. Respiratory Rhinitis has also been reported. Gastrointestinal Vomiting was a common occurrence. Hypersensitivity Reactions Very rarely, photosensitivity and worsening of psoriasis has been reported. Miscellaneous .....There have been very rare reports of weight gain, arthritis, and retroperitoneal fibrosis (relationship to Lopressor has not been definitely established).	CONTRAINDICATIONS/Lopressor Hypersensitivity to Lopressor and related derivatives, or to any of the excipients; hypersensitivity to other beta-blockers (cross sensitivity between beta-blockers can occur). Sick-sinus syndrome. Severe peripheral arterial circulatory disorders. Pheochromocytoma WARNINGS/Lopressor Pheochromocytoma: In patients known to have, or suspected of having, a pheochromocytoma, Lopressor is contraindicated. If Lopressor is required, it should be given in combination with an alpha blocker, and only after the alpha blocker has been initiated. Administration of beta blockers alone in the setting of pheochromocytoma have been associated with a paradoxical increase in blood pressure due to the attenuation of beta-mediated vasodilatation in skeletal muscle.

Back to Summary Page

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)	WARNINGS Neuroleptic Malignant Syndrome (NMS) PRECAUTIONS General Orthostatic Hypotension Initial Paragraph Seizure/Convulsion Potential for Cognitive and Motor Impairment Use in Patients with Concomitant Illness Safety Experience in Elderly Patients with Psychosis Associated with Alzheimer's Disease ADVERSE REACTIONS Initial Section .....In the tables and tabulations that follow, MedDRA dictionary terminology has been used..... Commonly Observed Adverse Events in Short-Term, Placebo-Controlled Trials of Patients with Schizophrenia Commonly Observed Adverse Events in Short-Term, Placebo-Controlled Trials of Patients with Bipolar Mania Table 1: Commonly Observed Adverse Events in Short-Term, Placebo-Controlled Trials of Patients with Bipolar Mania Adverse Events Occurring at an Incidence of 2% or More Among Aripiprazole-Treated Patients and Greater than Placebo in Short-Term, Placebo-Controlled Trials Table 2: Treatment-Emergent Adverse Events in Short-Term, Placebo-Controlled Trials Dose-Related Adverse Events Schizophrenia Extrapyramidal Symptoms Additional Findings Observed in Clinical Trials Adverse Events in Long-Term, Double-Blind, Placebo-Controlled Trials Other Adverse Events Observed During the Pre-marketing Evaluation of Aripiprazole	WARNINGS/Neuroleptic Malignant Syndrome (NMS) .....Rare cases of NMS occurred during aripiprazole treatment in the worldwide clinical database.....

Avastin (bevacizumab) for Intravenous Use (click product name to read prescribing information) See MedWatch Safety Alert posted 9/25/2006 for additional information on Avastin and Reversible Posterior Leukoencephalopathy Syndrome (RPLS).	WARNINGS Reversible Posterior Leukoencephalopathy Syndrome (RPLS) ADVERSE REACTIONS Initial Section Reversible Posterior Leukoencephalopathy Syndrome (RPLS) Other Serious Adverse Events Respiratory Nasal Septum Perforation	WARNINGS/Reversible Posterior Leukoencephalopathy Syndrome (RPLS) RPLS has been reported in clinical studies (with an incidence of <0.1%) and in post-marketing experience. RPLS is a neurological disorder which can present with headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances. Mild to severe hypertension may be present, but is not necessary for diagnosis of RPLS. Magnetic Resonance Imaging (MRI) is necessary to confirm the diagnosis of RPLS. The onset of symptoms has been reported to occur from 16 hours to 1 year after initiation of Avastin. In patients developing RPLS, discontinue Avastin and initiate treatment of hypertension, if present. Symptoms usually resolve or improve within days, although some patients have experienced ongoing neurologic sequelae. The safety of reinitiating Avastin therapy in patients previously experiencing RPLS is not known.

Concerta (methylphenidate hydrochloride) Extended-Release Tablets (click product name to read prescribing information)	WARNINGS Serious Cardiovascular Events Sudden Death and Pre-Existing Structural Cardiac Abnormalities or Other Serious Heart Problems Children and Adolescents Adults Hypertension and Other Cardiovascular Conditions Assessing Cardiovascular Status in Patients Being Treated with Stimulant Medications Psychiatric Adverse Events Pre-Existing Psychosis Bipolar Illness Emergence of New Psychotic or Manic Symptoms Aggression Long-Term Suppression of Growth Seizures Visual Disturbance PRECAUTIONS Drug Interactions Monoamine Oxidase Inhibitors Pregnancy: Teratogenic Effects - Pregnancy Category C The safety of methylphenidate for use during human pregnancy has not been established. ADVERSE REACTIONS Hypertension Post-marketing Experience with Concerta	WARNINGS See highlighted prescribing information for new WARNINGS information as a result of a class labeling initiative for all central nervous system (CNS) stimulant medications that include safety language for cardiac and psychiatric events.

Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules (click product name to read prescribing information) See MedWatch Safety Alert posted 7/19/2006 for additional information on Triptans, Selective Serotonin Reuptake Inhibitors (SSRIs), Selective Serotonin/Norepinephrine Reuptake Inhibitors (SNRIs), and Serotonin Syndrome.	WARNINGS Serotonin Syndrome PRECAUTIONS Information for Patients Serotonin Syndrome Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of Cymbalta and triptans, tramadol or other serotonergic agents. Drug Interactions Serotonergic Drugs Triptans	WARNINGS/Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome may occur with Cymbalta treatment, particularly with concomitant use of serotonergic drugs (including triptans) and with drugs which impair metabolism of serotonin (including MAOIs). Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The concomitant use of Cymbalta with MAOIs intended to treat depression is contraindicated. If concomitant treatment of Cymbalta with a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. The concomitant use of Cymbalta with serotonin precursors (such as tryptophan) is not recommended.

Effexor (venlafaxine hydrochloride) Tablets (click product name to read prescribing information) See MedWatch Safety Alert posted 7/19/2006 for additional information on Triptans, Selective Serotonin Reuptake Inhibitors (SSRIs), Selective Serotonin/Norepinephrine Reuptake Inhibitors (SNRIs), and Serotonin Syndrome.	WARNINGS Serotonin Syndrome PRECAUTIONS Information for Patients Concomitant Medication Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of Effexor and triptans, tramadol, tryptophan supplements or other serotonergic agents. Drug Interactions Serotonergic Drugs Triptans	WARNINGS/Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome may occur with Effexor treatment, particularly with concomitant use of serotonergic drugs (including SSRIs, SNRIs and triptans) and with drugs that impair metabolism of serotonin (including MAOIs). Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The concomitant use of Effexor with MAOIs intended to treat depression is contraindicated. If concomitant treatment of Effexor with an SSRI, an SNRI or a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. The concomitant use of Effexor with serotonin precursors (such as tryptophan supplements) is not recommended.

Effexor XR (venlafaxine hydrochloride) Extended- Release Capsules (click product name to read prescribing information) See MedWatch Safety Alert posted 7/19/2006 for additional information on Triptans, Selective Serotonin Reuptake Inhibitors (SSRIs), Selective Serotonin/Norepinephrine Reuptake Inhibitors (SNRIs), and Serotonin Syndrome.	WARNINGS Serotonin Syndrome PRECAUTIONS Information for Patients Concomitant Medication Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of Effexor XR and triptans, tramadol, tryptophan supplements or other serotonergic agents. Drug Interactions Serotonergic Drugs Triptans	WARNINGS/Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome may occur with Effexor XR treatment, particularly with concomitant use of serotonergic drugs (including SSRIs, SNRIs and triptans) and with drugs that impair metabolism of serotonin (including MAOIs). Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The concomitant use of Effexor XR with MAOIs intended to treat depression is contraindicated. If concomitant treatment of Effexor XR with an SSRI, an SNRI or a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. The concomitant use of Effexor XR with serotonin precursors (such as tryptophan supplements) is not recommended.

Ethrane (enflurane, USP) Liquid for Inhalation (click product name to read prescribing information)	WARNINGS Perioperative Hyperkalemia Malignant Hyperthermia ADVERSE REACTIONS There have been rare post-marketing reports of hepatic failure and hepatic necrosis associated with the use of potent volatile anesthetic agents, including Ethrane (enflurane, USP). Due to the spontaneous nature of these reports, the actual incidence and relationship of Ethrane (enflurane, USP) to these events cannot be established with certainty.	WARNINGS/Perioperative Hyperkalemia Use of inhaled anesthetic agents has been associated with rare increases in serum potassium levels that have resulted in cardiac arrhythmias and death in pediatric patients during the postoperative period. Patients with latent as well as overt neuromuscular disease, particularly Duchenne muscular dystrophy, appear to be most vulnerable. Concomitant use of succinylcholine has been associated with most, but not all, of these cases. These patients also experienced significant elevations in serum creatinine kinase levels and, in some cases, changes in urine consistent with myoglobinuria. Despite the similarity in presentation to malignant hyperthermia, none of these patients exhibited signs or symptoms of muscle rigidity or hypermetabolic state. Early and aggressive intervention to treat the hyperkalemia and resistant arrhythmias is recommended, as is subsequent evaluation for latent neuromuscular disease. WARNINGS/Malignant Hyperthermia In susceptible individuals, enflurane anesthesia may trigger a skeletal muscle hypermetabolic state leading to high oxygen demand and the clinical syndrome known as malignant hyperthermia. The syndrome includes nonspecific features such as muscle rigidity, tachycardia, tachypnea, cyanosis, arrhythmias and unstable blood pressure..... .....Treatment includes discontinuance of triggering agents (e.g., enflurane), administration of intravenous dantrolene sodium, and application of supportive therapy. Such therapy includes vigorous efforts to restore body temperature to normal, respiratory and circulatory support as indicated, and management of electrolyte-fluid-acid-base derangement. (Consult prescribing information for dantrolene sodium intravenous for additional information on patient management.) Renal failure may appear later, and urine flow should be sustained if possible.....

Lamictal (lamotrigine) Tablets Lamictal (lamotrigine) Chewable Dispersible Tablets (click product name to read prescribing information)	WARNINGS Hypersensitivity Reactions Acute Multiorgan Failure PRECAUTIONS Concomitant Use With Oral Contraceptives Dermatological Events It is recommended that Lamictal not be restarted..... Use in Patients with Concomitant Illness Information for Patients .....Patients should be advised to notify their physician if they stop taking Lamictal..... Drug Interactions Oral Contraceptives Other Hormonal Contraceptives or Hormone Replacement Therapy Felbamate Gabapentin Levetiracetam Olanzapine Oxcarbazepine Pregabalin Rifampin Topiramate Zonisamide Table 3: Summary of Drug Interactions with Lamictal PATIENT PACKAGE INSERT	WARNINGS/Hypersensitivity Reactions Hypersensitivity reactions, some fatal or life threatening, have also occurred. Some of these reactions have included clinical features of multiorgan failure/dysfunction, including hepatic abnormalities and evidence of disseminated intravascular coagulation. It is important to note that early manifestations of hypersensitivity (e.g., fever, lymphadenopathy) may be present even though a rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. Lamictal should be discontinued if an alternative etiology for the signs or symptoms cannot be established. Prior to initiation of treatment with Lamictal, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity (e.g., fever, lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately. WARNINGS/Acute Multiorgan Failure Multiorgan failure, which in some cases has been fatal or irreversible, has been observed in patients receiving Lamictal. Fatalities associated with multiorgan failure and various degrees of hepatic failure have been reported in 2 of 3,796 adult patients and 4 of 2,435 pediatric patients who received Lamictal in clinical trials. No such fatalities have been reported in bipolar patients in clinical trials. Rare fatalities from multiorgan failure have also been reported in compassionate plea and post-marketing use. The majority of these deaths occurred in association with other serious medical events, including status epilepticus and overwhelming sepsis, and hantavirus making it difficult to identify the initial cause.....

Magnevist (brand of gadopentetate dimeglumine) Injection (click product name to read prescribing information)	WARNINGS & PRECAUTIONS Hypersensitivity Reactions Acute Renal Failure Injection Site Reactions Interference with Visualization of Lesions Visible with Non-contrast MRI Patient Counseling Information Laboratory Test Findings	See highlighted prescribing information for new WARNINGS & PRECAUTIONS information.

Neumega (oprelvekin) (click product name to read prescribing information)	WARNINGS Cardiovascular Events ADVERSE REACTIONS Post-marketing Reports Papilledema Visual Disturbances Ranging from Blurred Vision to Blindness Optic Neuropathy Ventricular Arrthymias	WARNINGS/Cardiovascular Events In the post-marketing setting, ventricular arrhythmias have been reported, generally occurring within two to seven days of initiation of treatment.

Ortho Evra (norelgestromin/ethinyl estradiol transdermal system) (click product name to read prescribing information) See MedWatch Safety Alert posted 9/20/2006 for additional information on the risk of venous thromboembolism.	WARNINGS PATIENT PACKAGE INSERT Other Considerations Before Using Ortho Evra Risks of Using Hormonal Contraceptives, Including Ortho Evra Risk of Developing Blood Clots	See highlighted prescribing information for new WARNINGS information that describe the results of two epidemiology studies designed to assess the risk of venous thromboembolism in users of Ortho Evra compared to users of oral contraceptives containing norgestimate and 35 micrograms of ethinyl estradiol.

Prozac (fluoxetine capsules, USP and oral solution, USP) (click product name to read prescribing information) See MedWatch Safety Alert posted 7/19/2006 for additional details on Triptans, Selective Serotonin Reuptake Inhibitors (SSRIs), Selective Serotonin/Norepinephrine Reuptake Inhibitors (SNRIs), and Serotonin Syndrome.	WARNINGS Serotonin Syndrome PRECAUTIONS Information for Patients Serotonin Syndrome Drug Interactions Serotonergic Drugs Triptans	WARNINGS/Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome may occur with Prozac treatment, particularly with concomitant use of serotonergic drugs (including triptans) and with drugs which impair metabolism of serotonin (including MAOIs). Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The concomitant use of Prozac with MAOIs intended to treat depression is contraindicated. If concomitant treatment of Prozac with a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. The concomitant use of Prozac with serotonin precursors (such as tryptophan) is not recommended.

Symbyax (olanzapine and fluoxetine HCl capsules) (click product name to read prescribing information) See MedWatch Safety Alert posted 7/19/2006 for additional information on Triptans, Selective Serotonin Reuptake Inhibitors (SSRIs), Selective Serotonin/Norepinephrine Reuptake Inhibitors (SNRIs), and Serotonin Syndrome.	WARNINGS Serotonin Syndrome PRECAUTIONS Information for Patients Serotonin Syndrome Drug Interactions Serotonergic Drugs Triptans	WARNINGS/Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome may occur with Symbyax treatment, particularly with concomitant use of serotonergic drugs (including triptans) and with drugs which impair metabolism of serotonin (including MAOIs). Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The concomitant use of Symbyax with MAOIs intended to treat depression is contraindicated. If concomitant treatment of Symbyax with a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. The concomitant use of Symbyax with serotonin precursors (such as tryptophan) is not recommended.

Zarontin (ethosuximide) Capsules Please contact Pfizer at 1-800-879-3477 for prescribing information.	WARNINGS Usage in Pregnancy ADVERSE REACTIONS Body as a Whole Allergic Reaction	WARNINGS/Usage in Pregnancy Ethosuximide crosses the placenta. Cases of birth defects have been reported with ethosuximide. Ethosuximide is excreted in human breast milk. Because the effects of ethosuximide on the nursing infant are unknown, caution should be exercised when the ethosuximide is administered to a nursing mother. Ethosuximide should be used in nursing mothers only if the benefits clearly outweigh the risks.

Back to Summary Page

Brand (Generic) Name	Sections Modified
Actoplus Met (pioglitazone hydrochloride and metformin hydrochloride tablets) (click product name to read prescribing information)	PRECAUTIONS Carcinogenicity, Mutagenesis, Impairment of Fertility Pioglitazone Hydrochloride Bladder Cancer

Actos (pioglitazone hydrochloride) Tablets (click product name to read prescribing information)	PRECAUTIONS Carcinogenicity, Mutagenesis, Impairment of Fertility Bladder Cancer

Azopt (brinzolamide ophthalmic suspension) 1% (click product name to read prescribing information)	PRECAUTIONS Pediatric Use

Betaxon (levobetaxolol hydrochloride ophthalmic suspension), 0.5% as base (click product name to read prescribing information)	PRECAUTIONS Pediatric Use ADVERSE REACTIONS In a three-month, multi-center, double-masked, active-controlled trial in pediatric patients, the adverse event profile of Betaxon Ophthalmic Suspension was comparable to that seen in adult and elderly patients.

Elmiron (pentosan polysulfate sodium) Capsules (click product name to read prescribing information)	PRECAUTIONS General .....Patients undergoing invasive procedures or having signs/symptoms of underlying coagulopathy or other increased risk of bleeding (due to other therapies such as coumarin anticoagulants, heparin, t-PA, streptokinase, high dose aspirin, or nonsteroidal anti-inflammatory drugs) should be evaluated for hemorrhage..... Carcinogenicity, Mutagenesis, Impairment of Fertility Long term carcinogenicity studies of Elmiron in F344/N rats and B6C3F1 mice have been conducted. In these studies, Elmiron was orally administered once daily via gavage, 5 days per week, for up to 2 years.....

Enbrel (entanercept) for Subcutaneous Injection (click product name to read prescribing information)	PRECAUTIONS Autoimmunity Autoimmune Hepatitis ADVERSE REACTIONS Adverse Reaction Information from Spontaneous Reports Hepatobiliary Autoimmune Hepatitis

Fuzeon (enfuvirtide) for Injection (click product name to read prescribing information)	PRECAUTIONS Pediatric Use ADVERSE REACTIONS Initial Section Local Injection Site Reactions Adverse Events in Pediatric Patients

Gleevec (imatinib mesylate) Tablets (click product name to read prescribing information)	PRECAUTIONS General Severe Congestive Heart Failure and Left Ventricular Dysfunction Hematologic Toxicity .....In pediatric CML patients the most frequent toxicities observed were grade 3 or 4 cytopenias involving neutropenia, thrombocytopenia and anemia. These generally occur within the first several months of therapy. Pediatric Use ADVERSE REACTIONS Adverse Events in Pediatric Population

Hepsera (adefovir dipivoxil) Tablets (click product name to read prescribing information)	PRECAUTIONS .....The evaluation of the effect of adefovir on the pharmacokinetics of pegylated interferon alpha-2a was inconclusive due to high variability.

IC-Green (indocyanine green for injection, USP) Sterile (click product name to read prescribing information)	PRECAUTIONS General IC-Green Powder and Solution: IC-Green is unstable in aqueous solution and must be used within 6 hours.

Nascobal (cyanocobalamin, USP) Nasal Spray (click product name to read prescribing information)	PRECAUTIONS Information for Patients Careful instructions on the actuator assembly, removal of the safety clip, priming of the actuator and nasal administration of Nascobal Nasal Spray should be given to the patient. Although instructions for patients are supplied with individual bottles, procedures for use should be demonstrated to each patient.

Nexium (esomeprazole magnesium) Delayed-Release Capsules (click product name to read prescribing information)	PRECAUTIONS Drug Interactions Atazanavir ADVERSE REACTIONS Post-marketing Reports Gastrointestinal Disorders Stomatitis Hepatobiliary Disorders Hepatic Failure Infections and Infestations GI Candidiasis Musculoskeletal and Connective Tissue Disorders Muscular Weakness Nervous System Disorders Hepatic Encephalopathy Taste Disturbance Psychiatric Disorders Aggression Agitation Hallucination Renal and Urinary Disorders Interstitial Nephritis Reproductive System and Breast Disorders Gynecomastia Respiratory, Thoracic and Mediastinal Disorders Bronchospasm Skin and Subcutaneous Tissue Disorders Hyperhidrosis Photosensitivity

Nexium I.V. (esomeprazole sodium) for Injection (click product name to read prescribing information)	PRECAUTIONS Drug Interactions Atazanavir ADVERSE REACTIONS Safety Experience with Oral Nexium Post-marketing Reports Gastrointestinal Disorders Stomatitis Hepatobiliary Disorders Hepatic Failure Infections and Infestations GI Candidiasis Musculoskeletal and Connective Tissue Disorders Muscular Weakness Nervous System Disorders Hepatic Encephalopathy Taste Disturbance Psychiatric Disorders Aggression Agitation Hallucination Renal and Urinary Disorders Interstitial Nephritis Reproductive System and Breast Disorders Gynecomastia Respiratory, Thoracic and Mediastinal Disorders Bronchospasm Skin and Subcutaneous Tissue Disorders Hyperhidrosis Photosensitivity

Noroxin (norfloxacin) Tablets (click product name to read prescribing information)	PRECAUTIONS Drug Interactions Quinolones Quinolones, including norfloxacin, have been shown in vitro to inhibit CYP1A2. Concomitant use with drugs metabolized by CYP1A2 (e.g., caffeine, clozapine, ropinirole, tacrine, theophylline, tizanidine) may result in increased substrate drug concentrations when given in usual doses. Patients taking any of these drugs concomitantly with norfloxacin should be carefully monitored. Some quinolones have also been shown to interfere with the metabolism of caffeine. This may lead to reduced clearance of caffeine and a prolongation of it's the plasma half-life that may lead to accumulation of caffeine in plasma when products containing caffeine are consumed while taking norfloxacin.

Prilosec (omeprazole) Delayed-Release Capsules (click product name to read prescribing information)	PRECAUTIONS Drug Interactions Other Atazanavir

Risperdal Consta (risperidone) Long-Acting Injection (click product name to read prescribing information)	PRECAUTIONS Drug Interactions Amitriptyline Fluoxetine and Paroxetine .....Paroxetine lowered the concentration of 9-hydroxyrisperidone by about 10%..... Geriatric Use Concomitant use with Furosemide in Elderly Patients with Dementia-Related Psychosis

Rituxan (rituximab) (click product name to read prescribing information)	PRECAUTIONS Geriatric Use ADVERSE REACTIONS Previously Untreated, Follicular, CD20-Positive, B-Cell NHL Previously Untreated, Low-Grade, CD20-Positive, B-Cell NHL

WelChol (colesevelam hydrochloride) Tablets (click product name to read prescribing information)	PRECAUTIONS General Drug Interactions

Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate (click product name to read prescribing information) See MedWatch Safety Alert posted 7/19/2006 for additional details on SSRIs and Treatment Challenges of Depression in Pregnancy.	PRECAUTIONS Pregnancy Nonteratogenic Effects

Back to Summary Page

Brand (Generic) Name	Sections Modified
Atrovent HFA (ipratropium bromide HFA) Inhalation Aerosol (click product name to read prescribing information)	ADVERSE REACTIONS Pruritus

Azmacort (triamcinolone acetonide) Inhalation Aerosol Please contact Kos Pharmaceuticals at 1-888-454-7437 for prescribing information.	ADVERSE REACTIONS .....The patients were treated with Azmacort Inhalation Aerosol (including doses ranging from 150 to 600 mcg twice daily for 6 weeks) or placebo......

Back to Summary Page