MedWatch - January 2004 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 2004

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
Cenestin (synthetic conjugated estrogens, A) Tablets (click product name to read prescribing information)	CONTRAINDICATIONS BOXED WARNINGS Cardiovascular and Other Risks WARNINGS Cardiovascular Disorders Coronary Heart Disease and Stroke Venous Thromboembolism Malignant Neoplasms Breast Cancer PRECAUTIONS ADVERSE REACTIONS PATIENT PACKAGE INSERT	Extensive labeling changes to incorporate data from the Women's Health Initiative. Please see the prescribing information for the new text. CONTRAINDICATIONS Cenestin should not be used in individuals with any of the following conditions ... (see prescribing information). BOXED WARNINGS Estrogens with and without progestins should not be used for the prevention of cardiovascular disease. WARNINGS Women's Health Initiative (WHI) study data added.

Climara (estradiol transdermal system) Please contact Berlex Laboratories at 1-888-237-5394 (press 4 then press 2) for prescribing information.	CONTRAINDICATIONS BOXED WARNINGS WARNINGS Cardiovascular Disorders Coronary Heart Disease and Stroke Venous Thromboembolism Malignant Neoplasms Breast Cancer PRECAUTIONS ADVERSE REACTIONS PATIENT PACKAGE INSERT	Extensive labeling changes to incorporate data from the Women's Health Initiative. CONTRAINDICATIONS Progestogens/estrogens should not be used in individuals with any of the following conditions or circumstances: known, suspected, or history of cancer of the breast and liver dysfunction and disease... BOXED WARNINGS Estrogens with and without progestins should not be used for the prevention of cardiovascular disease. WARNINGS Women's Health Initiative (WHI) study data added.

Clinimix - Sulfite Free Clinimix E - Sulfite Free Injection Please contact Baxter Healthcare at 1-800-422-9837 for prescribing information.	CONTRAINDICATIONS PRECAUTIONS Geriatric Use	Solutions containing corn-derived dextrose may be contraindicated in patients with known allergy to corn or corn products.

Diabinese (chlorpropamide) Tablets Please contact Pfizer at 1-800-879-3477 for prescribing information.	CONTRAINDICATIONS PRECAUTIONS General Hypoglycemia Loss of Control of Blood Glucose Laboratory Tests Drug Interactions Miconazole Pregnancy Teratogenic Effects Nonteratogenic Effects Ability to Drive and Use Machines ADVERSE REACTIONS Body as a Whole Central and Peripheral Nervous System Liver/Biliary Metabolic/Nutritional Reactions	Contraindications include known hypersensitivity to any component of this medicine and Type 1 diabetes.

Femhrt (norethindrone acetate/ethinyl estradiol tablets) (click product name to read prescribing information)	CONTRAINDICATIONS BOXED WARNINGS WARNINGS Cardiovascular Disorders Coronary Heart Disease and Stroke Venous Thromboembolism Induction of Malignant Neoplasms Breast Cancer PRECAUTIONS ADVERSE REACTIONS PATIENT PACKAGE INSERT	Extensive labeling changes to incorporate data from the Women's Health Initiative. Please see the prescribing information for the new text. CONTRAINDICATIONS Progestogens/estrogens should not be used in individuals with any of the following conditions or circumstances ... (see prescribing information). BOXED WARNINGS Estrogens with and without progestins should not be used for the prevention of cardiovascular disease. WARNINGS Women's Health Initiative (WHI) study data added.

Vivelle (estradiol) (click product name to read prescribing information)	CONTRAINDICATIONS BOXED WARNINGS WARNINGS Cardiovascular Disorders Coronary Heart Disease and Stroke Venous Thromboembolism Malignant Neoplasms Breast Cancer PRECAUTIONS ADVERSE REACTIONS PATIENT PACKAGE INSERT	Extensive labeling changes to incorporate data from the Women's Health Initiative and Heart and Estrogen/Progestin Replacement Study (HERS) Please see the package insert for new text. CONTRAINDICATIONS Estrogens should not be used in individuals with any of the following conditions ... (see prescribing information). BOXED WARNINGS Estrogens with and without progestins should not be used for the prevention of cardiovascular disease. WARNINGS Women's Health Initiative (WHI) study data added.

Vivelle-Dot (estradiol) (click product name to read prescribing information)	CONTRAINDICATIONS BOXED WARNINGS WARNINGS Cardiovascular Disorders Coronary Heart Disease and Stroke Venous Thromboembolism Malignant Neoplasms Breast Cancer PRECAUTIONS ADVERSE REACTIONS PATIENT PACKAGE INSERT	Extensive labeling changes to incorporate data from the Women's Health Initiative. Please see the prescribing information for the new text. CONTRAINDICATIONS Estrogens should not be used in individuals with any of the following conditions... (see prescribing information). BOXED WARNINGS Estrogens with and without progestins should not be used for the prevention of cardiovascular disease. WARNINGS Women's Health Initiative (WHI) study data added.

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Brand (Generic) Name

Sections Modified

Summary of Changes to Contraindications and Warnings

Methotrexate Sodium for Injection

Methotrexate Sodium Injection

(click product name to read prescribing information)

BOXED WARNINGS

PRECAUTIONS

General
Drug Interactions
Pediatric Use

ADVERSE REACTIONS

Blood and Lymphatic System
- agranulocytosis
- eosinophilia
Hepatobiliary Disorders
- Hepatic Failure
Infection
Pulmonary System
- Alveolitis
Urogenital System
- Proteinuria
- Fetal Death
Other Rarer Reactions

Methotrexate-induced lung disease, including acute or chronic interstitial pneumonitis, is a potentially dangerous lesion, which may occur acutely at any time during therapy and has been reported at low doses. It is not always fully reversible and fatalities have been reported. Pulmonary symptoms (especially a dry, nonproductive cough) may require interruption of treatment and careful investigation.

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Brand (Generic) Name

Sections Modified

Summary of Changes to Contraindications and Warnings

Aggrenox (aspirin/extended-release dipyridamole) Capsules

(click product name to read prescribing information)

WARNINGS

Pregnancy

PRECAUTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility
Pregnancy
Nursing Mothers

Aggrenox can cause fetal harm when administered to a pregnant woman. Maternal aspirin use during later stages of pregnancy may cause low birth weight, increased incidence for intracranial hemorrhage in premature infants, stillbirths and neonatal death. Because of the above and because of the known effects of nonsteroidal anti-inflammatory drugs (NSAIDs) on the fetal cardiovascular system (closure of the ductus arteriosus), Aggrenox should be avoided in the third trimester of pregnancy.

Aspirin has been shown to be teratogenic in rats (spina bifida, exencephaly, microphthalmia and coelosomia) and rabbits (congested fetuses, agenesis of skull and upper jaw, generalized edema with malformation of the head, and diaphanous skin) at oral doses of 330 mg/kg/day and 110 mg/kg/day, respectively.

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Brand (Generic) Name	Sections Modified
Ancef (cefazolin for injection) (click product name to read prescribing information)	PRECAUTIONS General ADVERSE REACTIONS Hepatic Renal

Aredia (pamidronate disodium injection) (click product name to read prescribing information)	PRECAUTIONS Pregnancy Category D

Celebrex (celecoxib) Capsules (click product name to read prescribing information)	PRECAUTIONS Nursing Mothers

Cleocin HCl (clindamycin hydrochloride capsules) Cleocin Phosphate Sterile Solution (clindamycin injection) Cleocin Phosphate IV Sterile Solution (clindamycin injection, in 5% dextrose) (click product name to read prescribing information)	SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria. PRECAUTIONS General Information for Patients

Crixivan (indinavir sulfate) Capsules (click product name to read prescribing information)	PRECAUTIONS Tubulointerstitial Nephritis Immune Reconstitution Syndrome Drug Interactions Atazanavir PATIENT PACKAGE INSERT What Are The Possible Side Effects Of Crixivan? Marketing Experience

Eloxatin (oxaliplatin) for Injection (click product name to read prescribing information)	PRECAUTIONS Neuropathy Pulmonary Toxicity Patients with Renal Impairment Geriatric Use Drug Interactions ADVERSE REACTIONS Patients Previously Untreated for Advanced Colorectal Cancer Table 8 Table 9 Previously Treated Patients with Advanced Colorectal Cancer Table 10 Table 11 Table 12 Thrombocytopenia Neutropenia Gastrointestinal Dermatologic Neurologic Anticoagulation Hemorrhage Renal Table 14 Table 15 Thromboembolism

Keflex (cephalexin) Pulvules Please contact Eli Lilly and Co. at 1-800-545-5979 for prescribing information	PRECAUTIONS Geriatric Use

Lamictal (lamotrigine) Tablets and Chewable Dispersible Tablets (click product name to read prescribing information)	PRECAUTIONS Effects of Lamotrigine on the Pharmacokinetics of Other Drugs Valproate Acid Added To Lamictal

Lamisil (terbinafine hydrochloride tablets) Tablets (click product name to read prescribing information)	PRECAUTIONS Drug Interactions ADVERSE REACTIONS Angioedema Cutaneous and Systemic Lupus Erythematosus

Myleran (busulfan) Tablets (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Norvasc (amlodipine besylate) Tablets (click product name to read prescribing information)	PRECAUTIONS Pediatric Use

Oxistat (oxiconazole nitrate) Cream and Lotion (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Phenergan with dextromethorphan (promethazine HCl and dextromethorphan hydrobromide) Syrup Please contact Wyeth Pharmaceuticals at 1-800-395-9938 for prescribing information.	PRECAUTIONS Labor and Delivery Limited data suggest that use of promethazine HCl during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. The effect on later growth and development of the newborn is unknown.

Protonix (pantoprazole) Delayed-Release Tablets (click product name to read prescribing information)	PRECAUTIONS Laboratory Tests

Proventil HFA (albuterol sulfate) Inhalation Aerosol Please contact 3M Pharmaceuticals at 1-800-364-3577 for prescribing information.	PRECAUTIONS Carcinogenesis, Mutagenesis, and Impairment of Fertility Pregnancy

Provigil (modafinil) Tablets (click product name to read prescribing information)	PRECAUTIONS Diagnosis of Sleep Disorders CPAP Use in Patients with OSAHS Cardiovascular System Drug Interactions CNS Active Drugs Methylphenidate Dextroamphetamine Clomipramine Triazolam Other Drugs Warfarin Ethinyl Estradiol Potential Interactions with Drugs That Inhibit, Induce, or are Metabolized by Cytochrome P-450 Isoenzymes and Other Hepatic Enzymes Carcinogenesis, Mutagenesis, Impairment of Fertility Impairment of Fertility Pregnancy Labor and Delivery Pediatric Use ADVERSE REACTIONS Laboratory Changes

Silvadene Cream (silver sulfadiazine cream) Please contact King Pharmaceuticals at 1-800-776-3637.	PRECAUTIONS Geriatric Use

Tequin (gatifloxacin) Tablets and Injection (click product name to read prescribing information)	SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria. PRECAUTIONS General Information for Patients ADVERSE REACTIONS Postmarketing Adverse Event Reports

Videx (didanosine) Chewable/Dispersible Tablets Videx (didanosine) Buffered Powder for Oral Solution Videx (didanosine) Pediatric Powder for Oral Solution Videx (didanosine) Delayed-Release Capsules Enteric Coated Beadlets (click product name to read prescribing information)	PRECAUTIONS Drug Interactions Nucleoside/Nucleotide Analogues Tenofovir Disoproxil Fumarate

Zithromax IV (azithromycin for injection) (click product name to read prescribing information)	SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria. PRECAUTIONS General Information for Patients ADVERSE REACTIONS Postmarketing Experience Cardiovascular QT Prolongation Torsades de Pointes

Zithromax (azithromycin tablets) Zithromax (azithromycin for oral suspension) (click product name to read prescribing information)	PRECAUTIONS General ADVERSE REACTIONS Postmarketing Experience Cardiovascular QT Prolongation Torsades de Pointes

Zyvox IV (linezolid) Injection, Tablets and Oral Suspension (click product name to read prescribing information)	SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria. PRECAUTIONS General Information for Patients

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Brand (Generic) Name	Sections Modified
Clarinex (desloratadine) Tablets Clarinex Reditabs (desloratadine rapidly disintegrating) Tablets (click product name to read prescribing information)	ADVERSE REACTIONS Palpitations

Detrol (tolterodine tartrate) Tablets (click product name to read prescribing information)	ADVERSE REACTIONS Postmarketing Surveillance Angioedema Palpitations

Detrol LA (tolterodine tartrate) Extended Release Capsules (click product name to read prescribing information)	ADVERSE REACTIONS Postmarketing Surveillance Angioedema Palpitations

Emend (aprepitant) Capsules (click product name to read prescribing information)	ADVERSE REACTIONS Laboratory Adverse Experiences

Norplant System (levonorgestrel implants) Please contact Wyeth at 1-800-395-9938 for prescribing information.	ADVERSE REACTIONS Postmarketing Visual Disturbances

Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets (click product name to read prescribing information)	ADVERSE REACTIONS Adverse Findings Observed in Short-Term Placebo-Controlled Trials With Paxil CR Premenstrual Dysphoric Disorder Commonly Observed Adverse Events Premenstrual Dysphonic Disorder Table 5

Protonix I.V. (pantoprazole sodium) for Injection (click product name to read prescribing information)	ADVERSE REACTIONS Postmarketing Reports Elevated CPK

Zomig and Zomig-ZMT (zolmitriptan) Tablets (click product name to read prescribing information)	ADVERSE REACTIONS Postmarketing Experience with Zomig Tablets Digestive Splenic Infarction

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