MedWatch - August 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) -- August 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
Accutane (isotretinoin) Capsules (click product name to read prescribing information)	CONTRAINDICATIONS & BOXED WARNINGS Information for Pharmacists PRECAUTIONS Information for Patients and Prescribers Drug Interactions Micro-dosed Progesterone Preparations Pediatric Use PATIENT INFORMATION CONSENT (for female patients concerning birth defects)	CONTRAINDICATIONS & BOXED WARNINGS: Although hormonal contraceptives are highly effective, there have been reports of pregnancy from women who have used oral contraceptives, as well as topical/injectable/implantable/insertable hormonal birth control products. Information for Pharmacists: Accutane must only be dispensed within seven days of the qualification date.

Relenza (zanamivir) Oral for Inhalation (click product name to read prescribing information)	CONTRAINDICATIONS PATIENT PACKAGE INSERT Who should not take Relenza? How and when should I take Relenza?	Relenza is contraindicated in patients with a known hypersensitivity to any component of the formulation (see DESCRIPTION). Each Relenza Rotadisk contains 4 regularly spaced double-foil blisters with each blister containing a powder mixture of 5 mg of zanamivir and 20 mg of lactose (which contains milk proteins).

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Advair (fluticasone propionate/salmeterol inhalation powder) Diskus (click product name to read prescribing information)	BOXED WARNING WARNINGS PRECAUTIONS Information for Patients	BOXED WARNING: Data from a large placebo-controlled US study that compared the safety of salmeterol (Serevent Inhalation Aerosol) or placebo added to usual asthma therapy showed a small but significant increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,174 patients treated for 28 weeks) versus those on placebo (4 of 13,179). Subgroup analyses suggest the risk may be greater in African-American patients compared to Caucasians (see WARNINGS). WARNINGS: Results of the Serevent Multicenter Asthma Research Trial (SMART) incorporated in a BOXED WARNING, WARNINGS, and PRECAUTIONS.

Serevent (salmeterol xinafoate) Inhalation Aerosol Serevent Diskus (salmeterol xinafoate Inhalation powder) (click product name to read prescribing information)	BOXED WARNING WARNINGS PRECAUTIONS Information for Patients	BOXED WARNING: Data from a large placebo-controlled US study that compared the safety of salmeterol (Serevent Inhalation Aerosol) or placebo added to usual asthma therapy showed a small but significant increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,174 patients treated for 28 weeks) versus those on placebo (4 of 13,179). Subgroup analyses suggest the risk may be greater in African-American patients compared to Caucasians (see WARNINGS and CLINICAL PHARMACOLOGY: Clinical Trials: Asthma: Salmeterol Multi-center Asthma Research Trial). WARNINGS: Results of the Serevent Multicenter Asthma Research Trial (SMART) incorporated in a BOXED WARNING, WARNINGS, and PRECAUTIONS.

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Fludara (fludarabine) for Injection (click product name to read prescribing information)	WARNINGS PRECAUTIONS Pediatric Use ADVERSE REACTIONS Hematopoietic Systems Nervous System Gastrointestinal System	Severe bone marrow suppression, notably anemia, thrombocytopenia and neutropenia, has been reported in patients treated with Fludara for Injection. In 12 pediatric patients with solid tumors, dose-limiting myelosuppression was observed with a loading dose of 8 mg/m² followed by 23.5 mg/m²/day for five days. Several instances of trilineage bone marrow hypoplasia or aplasia resulting in pancytopenia, sometimes resulting in death, have been reported in adult patients. In a clinical investigation using Fludara for Injection in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia (CLL) in adults, there was an unacceptably high incidence of fatal pulmonary toxicity.

Mykrox (metolazone) Tablets Please contact Celltech Pharmaceuticals at 1-800-234-5535 for prescribing information.	WARNINGS Cross-Allergy ADVERSE REACTIONS Dermatologic Hypersensitivity skin necrosis petechiae pruritus skin rashes Gastrointestinal nausea diarrhea abdominal pain	Cross-allergy may occur when Mykrox Tablets are given to patients known to be allergic to sulfonamide-derived drugs, thiazides, or quinethazone.

Nallpen (nafcillin sodium injection) (click product name to read prescribing information)	WARNINGS PRECAUTIONS Pediatric Use ADVERSE REACTIONS Local Reactions	SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. The first paragraph of the pseudomembranous colitis statements is now bolded.

3% Sorbitol Urologic Irrigation Solution (click product name to read prescribing information)	WARNINGS ADVERSE REACTIONS	Not for use in patients with documented or suspected fructose intolerance.

Suprax (cefixime) Tablets and Oral Suspension (click product name to read prescribing information)	WARNINGS ADVERSE REACTIONS Hypersensitivity Reactions	Anaphylactic/anaphylactoid reactions (including shock and fatalities) have been reported with the use of cefixime. Antibiotics, including Suprax, should be administered cautiously to any patient who has demonstrated some form of allergy, particularly to drugs.

Zaroxolyn (metolazone) Tablets Please contact Celltech Pharmaceuticals at 1-800-234-5535 for prescribing information.	WARNINGS Cross-Allergy ADVERSE REACTIONS Dermatologic Hypersensitivity skin necrosis petechiae pruritus Gastrointestinal Abdominal pain	Cross-allergy may occur when Zaroxolyn is given to patients known to be allergic to sulfonamide-derived drugs, thiazides, or quinethazone.

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Brand (Generic) Name	Sections Modified
Cleocin (clindamycin phosphate vaginal cream) (click product name to read prescribing information)	PRECAUTIONS Geriatric

Cytotec (misoprostol) Tablets (click product name to read prescribing information)	PRECAUTIONS ADVERSE REACTIONS Casual Relationship Unknown Cardiovascular

Lariam (mefloquine hydrochloride) Tablets (click product name to read prescribing information)	PRECAUTIONS Information for Patients MEDICATION GUIDE

Lotrel (amlodipine and benazepril HCl) Capsules (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Micro-K (potassium chloride) Extencaps Extended-Release Capsules Micro-K 10 (potassium chloride) Extencaps Extended-Release Capsules Please contact KV Pharmaceutical Company at 1-314-645-6600 for prescribing information.	PRECAUTIONS Geriatric Use

Orudis (ketoprofen) Capsules and Extended-Release Capsules (click product name to read prescribing information)	GENERAL PRECAUTIONS Geriatric Use

Prandin (repaglinide) Tablets (click product name to read prescribing information)	PRECAUTIONS Drug-Drug Interactions Gemfibrozil

R-Gene 10 (10% arginine hydrochloride injection) (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Skelid (tiludronate disodium) Tablets (click product name to read prescribing information)	PRECAUTIONS Pregnancy

Viadur (leuprolide acetate implant) (click product name to read prescribing information)	INFORMATION FOR PATIENTS & PHYSICIAN Physician & Patient Insert Instruction Booklet & Instruction Sheet

Vioxx (rofecoxib) Tablets and Suspension (click product name to read prescribing information)	PRECAUTIONS Hepatic Effects PATIENT PACKAGE INSERT

Viracept (nelfinavir mesylate) Oral Powder and Tablets (click product name to read prescribing information)	INFORMATION FOR PATIENTS PATIENT PACKAGE INSERT How should I take Viracept?

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Brand (Generic) Name	Sections Modified
Aciphex (rabeprazole sodium) Delayed-Release Tablets (click product name to read prescribing information)	ADVERSE REACTIONS Post-Marketing Adverse Events Severe dermatologic reactions, including toxic epidermal necrolysis (some fatal), Stevens-Johnson syndrome, and erythema multiforme.

MS Contin (morphine sulfate controlled-release) Tablets Please contact The Purdue Frederick Company at 1-888-726-7535 for prescribing information.	ADVERSE REACTIONS Less Frequently Observed Reactions Gastrointestinal Increases in hepatic enzymes

Prevacid (lansoprazole) Delayed-Release Capsules Prevacid (lansoprazole) for Delayed-Release Oral Suspension Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets (click product name to read prescribing information)	ADVERSE REACTIONS Post-marketing Adverse Events Body as a Whole Pancreatitis Skin and Appendages

Valtrex (valacyclovir hydrochloride) Caplets (click product name to read prescribing information)	ADVERSE REACTIONS Observed During Clinical Practice CNS Symptoms Tremors

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