MedWatch - May 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) -- May 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

Thalomid (thalidomide) Capsules

(click product name to read prescribing information)

BOXED WARNING

Venous Thromboembolic Events

CONTRAINDICATIONS

Thrombotic Events

PRECAUTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility

ADVERSE REACTIONS

Adverse Events in Multiple Myeloma Controlled Clinical Trial

BOXED WARNING

The use of Thalomid (thalidomide) in multiple myeloma results in an increased risk of venous thromboembolic events, such as deep venous thrombosis and pulmonary embolus. This risk increases significantly when thalidomide is used in combination with standard chemotherapeutic agents including dexamethasone...... Preliminary data suggest that patients who are appropriate candidates may benefit from concurrent prophylactic anticoagulation or aspirin treatment.

CONTRAINDICATIONS

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Brand (Generic) Name

Sections Modified

Summary of Changes to Contraindications and Warnings

Cesamet (nabilone) Capsules

(click product name to read prescribing information)

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

General
Information for Patients
Drug Interactions
Animal Pharmacology and/or Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Pregnancy: Teratogenic Effects. Pregnancy Category C
Nursing Mothers
Pediatric Use
Geriatric Use

ADVERSE REACTIONS

Commonly Encountered Reactions
Comparative Incidence of Reactions
Postmarketing Adverse Reactions

CONTRAINDICATIONS

Cesamet is contraindicated in any patient known to be hypersensitive to any cannabinoid.

WARNINGS

See prescribing information for revised text. (Entire section revised.)

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Capozide (captopril and hydrochlorothiazide tablets, USP) (click product name to read prescribing information)	WARNINGS Captoril Head and Neck Angioedema Intestinal Angioedema PRECAUTIONS Information for Patients ADVERSE REACTIONS Captopril Angioedema	Head and Neck Angioedema: Angioedema involving the extremities, face, lips, mucous membranes, tongue, glottis or larynx has been seen in patients treated with ACE inhibitors, including captopril..... Intestinal Angioedema: Intestinal angioedema has been reported in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal. The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.

Retrovir (zidovudine) Tablets, Capsules, and Syrup (click product name to read prescribing information)	WARNINGS Use with Interferon- and Ribavirin-Based Regimens PRECAUTIONS Immune Reconstitution Syndrome	In vitro studies have shown ribavirin can reduce the phosphorylation of pyrimidine nucleoside analogues such as zidovudine. Although no evidence of a pharmacokinetic or pharmacodynamic interaction (e.g., loss of HIV/HCV virologic suppression) was seen when ribavirin was coadministered with zidovudine in HIV/HCV co-infected patients, hepatic decompensation (some fatal) has occurred in HIV/HCV co-infected patients receiving combination antiretroviral therapy for HIV and interferon alfa with or without ribavirin. Patients receiving interferon alfa with or without ribavirin and Retrovir should be closely monitored for treatment-associated toxicities, especially hepatic decompensation, neutropenia, and anemia.....

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Brand (Generic) Name	Sections Modified
Androderm (testosterone transdermal system) (click product name to read prescribing information)	PRECAUTIONS Information for Patients Skin burns have been reported at the patch site in several patients wearing an aluminized transdermal system during a magnetic resonance imaging scan (MRI)..... PATIENT PACKAGE INSERT

Avandamet (rosiglitazone maleate and metformin HCl) Tablets (click product name to read prescribing information)	PRECAUTIONS Weight Gain Hematologic ADVERSE REACTIONS Initial Section Table 5: Adverse Events (>5% in Any Treatment Group) Reported by Patients..... Table 6: Adverse Events (≥5% in Any Treatment Group) Reported by Patients.....

Cubicin (daptomycin for injection) (click product name to read prescribing information)	PRECAUTIONS Skeletal Muscle Drug Interactions Warfarin Geriatric Use ADVERSE REACTIONS Initial Section Gram-negative Infections Table 6: Incidence (%) of Adverse Events that Occurred in ≥5% of Patients in Either Cubicin or Comparator Treatment Groups in the S. aureus Bacteremia/Endocarditis Study The following events, not included above, were reported as possibly or probably drug-related in the Cubicin-treated group..... Laboratory Changes In the S. aureus bacteremia/endocarditis study..... Table 8: Incidence of Decreased Renal Function Based on Creatinine Clearance Levels

Gleevec (imatinib mesylate) Tablets (click product name to read prescribing information)	PRECAUTIONS Hepatoxicity ADVERSE REACTIONS Hepatotoxicity Gastrointestinal Stromal Tumors Table 10: Laboratory Abnormalities in GIST Trial

Lexiva (fosamprenavir calcium) Tablets (click product name to read prescribing information)	PRECAUTIONS Drug Interactions Table 13: Established and Other Potentially Significant Drug Interactions..... HIV Protease Inhibitor Atazanavir Other Agents Antimycobacterial Rifabutin

5.4% NephrAmine (essential amino acid injection) (click product name to read prescribing information)	PRECAUTIONS Pediatric Use

Noroxin (norfloxacin) Tablets (click product name to read prescribing information)	PRECAUTIONS Drug Interactions The concomitant administration of a non-steroidal anti-inflammatory drug (NSAID) with a quinolone, including norfloxacin, may increase the risk of CNS stimulation and convulsive seizures..... ADVERSE REACTIONS Post-marketing Nervous System/Psychiatric Hypoesthesia

Remicade (infliximab) for IV Injection (click product name to read prescribing information)	PRECAUTIONS Pediatric Use Active Crohn's Disease in Pediatric Patients Adverse Reactions in Pediatric Crohn's Disease

Sandostatin LAR Depot (octreotide acetate for injectable suspension) (click product name to read prescribing information)	PRECAUTIONS Pediatric Use Geriatric Use

Velcade (bortezomib) for Injection (click product name to read prescribing information)	PRECAUTIONS Peripheral Neuropathy Cardiac Disorders Pulmonary Disorders Thrombocytopenia/Neutropenia Information for Patients Ability to Drive or Operate Machinery or Impairment of Mental Ability ADVERSE REACTIONS Table 6: Most Commonly Reported Adverse Events..... Psychiatric Disorders Lower Respiratory/Lung Infections Description of Selected Adverse Events from the Phase 3 and Phase 2 Studies Eye Disorders Conjunctival Infection Irritation Gastrointestinal Disorders Gastroesophageal Reflux Immune System Disorders Angioedema Laryngeal Edema Infections and Infestations Sinusitis Catheter Related Infection Injury, Poisoning and Procedural Complications Catheter Related Complication Nervous System Disorders Paralysis Postherpetic Neuralgia Transient Ischemic Attack Skin and Subcutaneous Tissue Disorders Rash Leukocytoclastic Vasculitis Post-marketing Experience Acute Diffuse Infiltrative Pulmonary Disease Toxic Epidermal Necrolysis

Vfend I.V. (voriconazole) for Injection Vfend (voriconazole) Tablets Vfend (voriconazole) for Oral Suspension (click product name to read prescribing information)	PRECAUTIONS Drug Interactions Table 9: Effect of Other Drugs on Voriconazole Pharmacokinetics Oral Contraceptives Table 10: Effect of Voriconazole on Pharmacokinetics of Other Drugs Oral Contraceptives Women of Childbearing Potential

Zetia (ezetimibe) Tablets (click product name to read prescribing information)	PRECAUTIONS Concurrent administration of Zetia with a specific HMG-CoA reductase inhibitor or fenofibrate should be in accordance with the product labeling for that medication. Drug Interactions Fenofibrate ADVERSE REACTIONS Combination with Fenofibrate

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Brand (Generic) Name	Sections Modified
HalfLytely and Bisacodyl Tablets Bowel Prep Kit (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed release tablets) (click product name to read prescribing information)	ADVERSE REACTIONS Postmarketing cases of ischemic colitis.....

Neurontin (gabapentin) Capsules, Tablets, and Oral Solution (click product name to read prescribing information)	ADVERSE REACTIONS Other Adverse Events Observed During All Clinical Trials

Zometa (zoledronic acid) Injection (click product name to read prescribing information)	ADVERSE REACTIONS Hypercalcemia of Malignancy Flushing Post-marketing Experience

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