MedWatch - January 2003 Safety-Related Drug Labeling Changes

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Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 2003

The detailed view includes drug products with safety labeling changes to the CONTRAINDICATIONS, BOXED WARNING, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS sections. 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
Premarin (conjugated estrogen tablets, USP) (click product name to read label)	CONTRAINDICATIONS BOXED WARNING Cardiovascular and Other Risks WARNINGS Cardiovascular disorders Coronary heart disease and stroke Venous thromboembolism (VTE) Malignant neoplasm Breast cancer Visual abnormalities PRECAUTIONS General Addition of a progestin when a woman has not had a hysterectomy Elevated blood pressure Ovarian Cancer Patient Information Laboratory Tests Pregnancy Nursing Mothers Geriatric Use ADVERSE REACTIONS Genitourinary system Breasts Cardiovascular Eyes Central Nervous System Miscellaneous PATIENT INFORMATION	Estrogens with or without progestins should not be used for the prevention of cardiovascular disease. The Women's Health Initiative (WHI) reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women during 5 years of treatment with conjugated equine estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo.

Thalomid (thalidomide) Capsules (click product name to read label)	CONTRAINDICATIONS Pregnancy: Category X BOXED WARNING Prescribers Female Patients Male Patients PRECAUTIONS Laboratory Tests Pregnancy Testing Increased HIV Viral Load Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy ADVERSE REACTIONS Other Adverse Events Observed in ENL Patients Cardiovascular System Nervous System IMPORTANT INFORMATION AND WARNINGS FOR ALL PATIENTS	Revisions to the boxed warnings containing special information for prescribers, female patients, and male patients about procedures that must be followed to prevent fetal exposure.

Toprol-XL (metoprolol succinate) Extended Release Tablets (click product name to read label)	CONTRAINDICATIONS WARNINGS Peripheral Vascular Disease Calcium Channel Blockers PRECAUTIONS General Drug Interactions ADVERSE REACTIONS Hypertension and Angina Postmarketing Experience	Peripheral Vascular Disease: Beta-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Caution should be exercised in such individuals. Calcium Channel Blockers: Because of significant inotropic and chronotropic effects in patients treated with beta-blockers and calcium channel blockers of the verapamil and diltiazem type, caution should be exercised in patients treated with these agents concomitantly.

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Novantrone (mitoxantrone) for Injection Concentrate (click product name to read label)	BOXED WARNING WARNINGS General Secondary Leukemia PRECAUTIONS Geriatric Use Multiple Sclerosis Hormone-Refractory Prostate Cancer Acute Nonlymphocytic Leukemia	Secondary acute myelogenous leukemia (AML) has been reported in cancer patients treated with anthracyclines. NOVANTRONE is an anthracenedione, a related drug. Secondary AML has also been reported in cancer patients and multiple sclerosis patients who have been treated with NOVANTRONE.

Prempro /Premphase (conjugated estrogens/medroxyprogesterone acetate tablets) (click product name to read label)	BOXED WARNING WARNINGS Cardiovascular Disorders Malignant Neoplasms Breast Cancer	See summary for Premarin [above]

Rapamune (sirolimus) Oral Solution Rapamune (sirolimus) Tablets (click product name to read label)	BOXED WARNING WARNINGS PRECAUTIONS General Other Drug Interactions Herbal Preparations ADVERSE REACTIONS Other Clinical Experience	Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Liver Transplantation – Excess Mortality, Graft Loss, and Hepatic Artery Thrombosis (HAT): The use of sirolimus in combination with tacrolimus was associated with excess mortality and graft loss in a study in de novo liver transplant recipients.

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Atacand (candesartan cilexetil) Tablets (click product name to read label)	WARNINGS Fetal/Neonatal Morbidity and Mortality PRECAUTIONS General Drug Interactions Lithium	Post marketing experience has identified reports of fetal and neonatal toxicity in babies born to women treated with ATACAND during pregnancy.

Gemzar (gemcitabine HCl) for Injection (click product name to read label)	WARNINGS Hematology Pulmonary Renal Hepatic PRECAUTIONS Drug Interactions ADVERSE REACTIONS Single Agent Use Combination Use in Non-Small Lung Cancer Post-marketing experience Cardiovascular Vascular Disorders Skin Hepatic Pulmonary Renal	The previous Hemolytic-Uremic Syndrome [HUS] section has been repolaced with a new Hematology, Pulmonary, Renal, and Hepatic section.

Lopid (gemfibrozil) Tablets (click product name to read label)	WARNINGS ADVERSE REACTIONS	Cases of cholelithiasis have been reported with gemfibrozil therapy.

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Brand (Generic) Name	Sections Modified
5% Dextrose and Potassium Chloride Injection, USP in Viaflex Plus Container Please contact Baxter Healthcare at 1-800-422-9837 for product information.	PRECAUTIONS Carcinogenesis, Mutagenesis, Impairment of Fertility Nursing Mothers Pediatric Use

Actos (pioglitazone hydrochloride) Tablets (click product name to read label)	PRECAUTIONS Drug Interactions Oral Contraceptives

Busulfex (busulfan) Injection (click product name to read label)	PRECAUTIONS Special Populations Pediatric

Covera-HS (verapamil hydrochloride) Extended-Release Tablets, Controlled-Onset (click product name to read label)	PRECAUTIONS General Use in Patients with Attenuated [decreased] Neuromuscular Transmission Drug Interactions Cytochrome inducers/inhibitors Aspirin Grapefruit juice Drug-Drug Interactions Effects of Other Drugs on Verapamil Pharmacokinetics Aspirin Grapefruit Geriatric Use ADVERSE REACTIONS Nervous System

Dobutamine Hydrochloride in 5% Dextrose Injection, USP in Plastic Container	PRECAUTIONS Geriatric Use

Effexor (venlafaxine hydrochloride) Immediate Release Tablets (click product name to read label)	PRECAUTIONS General Changes in Appetite and Weight Hyponatremia Abnormal Bleeding Use in Patients with Concomitant Illness Carcinogenesis, Mutagenesis, and Impairment of Fertility Pregnancy Non-teratogenic Effects Information for Patients Concomitant Medications ADVERSE REACTIONS Adverse Findings Observed in Short-Term, Placebo-Controlled Studies Laboratory Changes Incidence in Controlled Trials Vital Sign Changes ECG Changes Postmarketing Reports

Effexor XR (venlafaxine hydrochloride) Extended Release Capsules (click product name to read label)	PRECAUTIONS General Changes in Appetite and Weight Hyponatremia Abnormal Bleeding Use in Patients with Concomitant Illness Carcinogenesis, Mutagenesis, and Impairment of Fertility Pregnancy Non-teratogenic Effects Information for Patients Concomitant Medications ADVERSE REACTIONS Adverse Findings Observed in Short-Term, Placebo-Controlled Studies Laboratory Changes Incidence in Controlled Trials Vital Sign Changes ECG Changes Postmarketing Reports

Emla Cream (lidocaine 2.5% and prilocaine 2.5%) Emla Anesthetic Disc (lidocaine 2.5% and prilocaine 2.5% cream) Topical Adhesive System (click product name to read label)	PRECAUTIONS Carcinogenesis, Mutagenesis, Impairment of Fertility ADVERSE REACTIONS Localized Reactions

Feldene (piroxicam) Capsules (click product name to read label)	PRECAUTIONS Geriatric Use

Femara (letrozole) Tablets (click product name to read label)	PRECAUTIONS Geriatric Use

Imdur (isosorbide mononitrate) Extended Release Tablets (click product name to read label)	PRECAUTIONS Geriatric Use

Larium (mefloquine hydrochloride) Tablets (click product name to read label)	PRECAUTIONS General Information for Patients Drug Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects Nursing Mothers Geriatric Use

Lithium Carbonate Tablets, USP Lithium Carbonate Capsules, USP Lithium Citrate Syrup, USP (click product name to read label)	PRECAUTIONS Drug Interactions

Megace (megestrol acetate tablets, USP) (click product name to read label)	PRECAUTIONS Geriatric Use

Methotrexate Sodium for Injection Methotrexate for Injection Please contact Wyeth-Ayerst Laboratories at 1-800-999-9384 for product information.	PRECAUTIONS Geriatric Use ADVERSE REACTIONS Organ System Toxicity Hematologic Pulmonary Renal Blood and Lymphatic System Disorders Hepatobiliary Disorders Infection

Nolvadex (tamoxifen citrate) Tablets (click product name to read label)	PRECAUTIONS Pediatric Use ADVERSE REACTIONS Pediatric Patients McCune-Albright Syndrome PATIENT INFORMATION SHEET Who Should Not Take Nolvadex?

Potassium Chloride in 5% Dextrose and Lactated Ringer's Injection, USP in Plastic Container Please contact Baxter Healthcare at 1-800-422-9837 for product information.	PRECAUTIONS Carcinogenesis, Mutagenesis, Impairment of Fertility Nursing Mothers Pediatric Use

Pulmicort Respules (budesonide inhalation suspension) (click product name to read label)	PRECAUTIONS Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects

Stromectol (ivermectin) Tablets	PRECAUTIONS General

Sustiva (efavirenz) Capsules (click product name to read label)	PRECAUTIONS General Carcinogenesis, Mutagenesis, Impairment of Fertility Patient Information

Tenormin (atenolol) Tablets Tenormin (atenolol) I.V. Injection (click product name to read label)	PRECAUTIONS Geriatric Use

Timolide (timolol maleate - hydrochlorothiazide) Tablets (click product name to read label)	PRECAUTIONS Geriatric Use

Travatan (travoprost ophthalmic solution) Sterile (click product name to read label)	PRECAUTIONS General Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects

Zanosar (streptozocin sterile powder) (click product name to read label)	PRECAUTIONS Geriatric Use

Ziac (bisoprolol fumarate and hydrochlorthiazide) Tablets (click product name to read label)	PRECAUTIONS Bisoprolol Furmarate ADVERSE REACTIONS Bisoprolol Fumarate Central Nervous System Cardiovascular Gastrointestinal Musculoskeletal Respiratory Genito-urinary General

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Brand (Generic) Name	Sections Modified
Mesnex (mesna) Injection and Tablets (click product name to read label)	ADVERSE REACTIONS PATIENT PACKAGE INSERT [Tablets Only]

Oxilan (ioxilan injection)	ADVERSE REACTIONS

Purinethol (mercaptopurine) Tablets (click product name to read label)	ADVERSE REACTIONS Miscellaneous

Taxotere (docetaxel) for Injection Concentrate (click product name to read label)	ADVERSE REACTIONS Postmarketing Experience Cutaneous Gastrointestional Hematologic Hepatic Neurologic Ophthalmologic

Zebeta (bisoprol fumarate) Tablets (click product name to read label)	ADVERSE REACTIONS Central Nervous System Gastrointestinal Musculoskeletal Skin Special Senses Genitourinary General

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