MedWatch - February 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) -- February 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
Travatan (travoprost ophthalmic solution) (click product name to read prescribing information)	CONTRAINDICATIONS PRECAUTIONS General	Known hypersensitivity to travoprost, benzalkonium chloride or any other ingredients in this product.

Zyban (bupropion hydrochloride) Sustained-Release Tablets (click product name to read prescribing information)	CONTRAINDICATIONS WARNINGS Patient Factors Clinical Situations Concomitant Medications Hepatic Impairment PRECAUTIONS Hepatic Impairment Renal Impairment Information for Patients Drug Interactions: Levodopa and Amantadine Drugs that Lower Seizure Threshold Smoking Cessation Alcohol Geriatric Use ADVERSE REACTIONS Hemic and Lymphatic Nervous System INFORMATION FOR PATIENTS	ZYBAN is contraindications in patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines). ZYBAN should be discontinued and not started in patients who experience a seizure while on treatment. Predisposing factors that may increase the risk of seizure with bupropion use include history of head trauma or prior seizure, central nervous system (CNS) tumor, the presence of severe hepatic cirrhosis, and concomitant medications that lower seizure threshold. Circumstances associated with an increased seizure risk include, among others, excessive use of alcohol or sedatives (including benzodiazepines); addiction to opiates.... Hepatic Impairment: ZYBAN should be used with extreme caution in patients with severe hepatic cirrhosis. In these patients a reduced frequency of dosing is required, as peak bupropion levels are substantially increased and accumulation is likely to occur in such patients to a greater extent than usual. The dose should not exceed 150 mg every other day in these patients.

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Brand (Generic) Name

Sections Modified

Summary of Changes to Contraindications and Warnings

AquaMEPHYTON (phytonadione) Injection

(click product name to read prescribing information)

BOXED WARNING

ADVERSE REACTIONS

WARNING - INTRAVENOUS USE

Severe reactions, including fatalities, have occurred during and immediately after the parenteral administration of AquaMEPHYTON (Phytonadione). Typically these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest. Some patients have exhibited these severe reactions on receiving AquaMEPHYTON for the first time. The majority of these reports occurred following intravenous administration, even when precautions have been taken to dilute the AquaMEPHYTON and to avoid rapid infusion. Therefore, the INTRAVENOUS route should be restricted to those situations where another route is not feasible and the increased risk involved is considered justified.

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Avelox (moxifloxacin hydrochloride) Tablets Avelox I.V. (moxifloxacin hydrochloride in sodium chloride injection) (click product name to read prescribing information)	WARNINGS PRECAUTIONS Drug Interactions: Warfarin ADVERSE REACTIONS Postmarketing Adverse Event Reports PATIENT INFORMATION	Achilles and other tendon ruptures that required surgical repair or resulted in prolonged disability have been reported with quinolones, including moxifloxacin.

Demerol (meperidine hydrochloride, USP) (click product name to read prescribing information)	WARNINGS Drug Abuse and Dependence Controlled Substance Drug Interactions Usage in Pregnancy Teratogenic Effects Labor and Delivery Nursing Mothers PRECAUTIONS Drug Interactions Acyclovir Cimetidine Phenytoin Ritonavir Special Risk Patients Usage in Hepatically Impaired Patients Usage in Renally Impaired Patients Pregnancy Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use ADVERSE REACTIONS	Monoamine Oxidase (MAO) Inhibitors added to WARNINGS section, subsection Drug Interactions. Teratogenic Effects: Pregnancy Category C. Although teratogenic effects in humans have not been documented, there are no adequate and well-controlled studies in pregnant women. Meperidine is known to cross the placental barrier. Nursing Mothers: Meperidine appears in the milk of nursing mothers receiving the drug. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the potential benefits of the drug to the nursing women.

Midamor (amiloride hydrochloride) Tablets (click product name to read prescribing information)	WARNINGS Hyperkalemia PRECAUTIONS Drug Interactions	"An angiotensin II receptor antagonist" added to the list of agents that when administered concomitantly with amiloride hydrochloride may increase the risk of hyperkalemia.

Moduretic (amiloride HCl-hydrochlorothiazide) Tablets (click product name to read prescribing information)	WARNINGS Hyperkalemia PRECAUTIONS Amiloride HCL	"An angiotensin II receptor antagonist" added to the list of agents that when administered concomitantly with amiloride hydrochloride may increase the risk of hyperkalemia.

Myambutol (ethambutol hydrochloride) (click product name to read prescribing information)	WARNINGS PRECAUTIONS Pregnancy Teratogenic Effects: Pregnancy Category Geriatric Use ADVERSE REACTIONS	MYAMBUTOL may produce decreases in visual acuity which appear to be due to optic neuritis. This effect may be related to dose and duration of treatment. This effect is generally reversible when administration of the drug is discontinued promptly. However, irreversible blindness has been reported. Liver toxicities including fatalities have been reported. Baseline and periodic assessment of hepatic function should be performed.

Rogaine (5% minoxidil topical solution) For Men Extra Strength Please contact Pharmacia Consumer Healthcare at 1-800-ROGAINE (1-800-764-2463) for Product Insert.	WARNINGS	The phrase "Flammable: Keep away from fire or flame" has been added to the WARNINGS section.

Zinc Chloride Injection, USP Please contact Abbott Laboratories at 1-800-255-5162 for Product Insert.	WARNINGS PRECAUTIONS Geriatric Use	This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration."

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Brand (Generic) Name	Sections Modified
Bactrim (sulfamethoxazole and trimethoprim) DS Tablets and Tablets, USP (click product name to read prescribing information)	PRECAUTIONS Geriatric Use Drug Interactions

Benicar (olmesartan medoxomil) Tablets (click product name to read prescribing information)	PRECAUTIONS Carcinogenesis, Mutagenesis, Impairment of Fertility ADVERSE REACTIONS Post-Marketing Experience

BiCNU (carmustine for injection) (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Blocadren (timolol maleate) Tablets (click product name to read prescribing information)	PRECAUTIONS Geriatric Use ADVERSE REACTIONS Body as a Whole

CeeNU (lomustine) Capsules (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

CellCept (mycophenolate mofetil capsules and tablets) CellCept (mycophenolate mofetil for oral suspension) Oral Suspension CellCept Intravenous (mycophenolate mofetil hydrochloride for injection) (click product name to read prescribing information)	PRECAUTIONS Drug Interactions Live Vaccines ADVERSE REACTIONS CellCept Oral

Lyophilized Cytoxan (cyclophosphamide for Injection, USP) Cytoxan Tablets (cyclophosphamide tablets, USP) Please contact Bristol-Myers Squibb Company at 212-546-4000 for Product Insert.	PRECAUTIONS Geriatric Use

Fragmin (dalteparin sodium) Injection (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Gastrocrom (cromolyn sodium, USP) Oral Concentrate (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Macrobid (nitrofurantoin monohydrate/ macrocrystals) Capsules (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Macrodantin (nitrofurantoin macrocrystals) Capsules (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Mytelase (ambenonium chloride) Capsules Please contact Sanofi-Synthelabo Inc. at 1-800-446-6267 for Product Insert.	PRECAUTIONS Geriatric Use

Nexium (esomeprazole magnesium) Delayed-Release Capsules (click product name to read prescribing information)	PRECAUTIONS Drug Interactions

Protonix IV (pantoprazole sodium) for Injection (click product name to read prescribing information)	PRECAUTIONS

Pulmicort Respules (budesonide inhalation suspension) (click product name to read prescribing information)	PRECAUTIONS Pediatric Use

Sandimmune Intravenous (cyclosporine injection) Sandimmune (cyclosporine) Oral Solution Sandimmune (cyclosporine) Soft Gelatin Capsules (click product name to read prescribing information)	PRECAUTIONS Drugs That May Potentiate Renal Dysfunction Drugs That Alter Cyclosporine Concentrations Drugs That Increase Cyclosporine Concentrations Drugs/Dietary Supplements That Decrease Cyclosporine Concentrations Nonsterodial Anti-Inflammatory Drug (NSAID) Interactions Methotrexate Interaction Other Drug Interactions

Tensilon (edrophonium chloride) Injectable Solution (click product name to read prescribing information)	PRECAUTIONS Pediatric Use

Talwin Nx (pentazocine hydrochloride and naloxone hydrochloride) Tablets Please contact Sanofi-Synthelabo Inc. at 1-800-446-6267 for Product Insert.	PRECAUTIONS Geriatric Use ADVERSE REACTIONS Other "Headache, chills, insomnia, weakness, urinary retention, paresthesia, serious skin reactions, including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis."

Zemplar (paricalcitol injection) (click product name to read prescribing information)	PRECAUTIONS Carcinogenesis, Mutagenesis, Impairment of Fertitly ADVERSE REACTIONS Adverse Events During Post-marketing Experience

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Brand (Generic) Name	Sections Modified
Oxilan (loxilan injection) (click product name to read prescribing information)	ADVERSE REACTIONS

Primacor (milrionone lactate) Injection Primacor (milrinone lactate) in 5% Dextrose Injection Please contact Sanofi-Synthelabo Inc. at 1-800-446-6267 for Product Insert.	ADVERSE REACTIONS Cardiovascular Effects Other Effects "In the post-marketing experience, there have been rare cases of torsades de pointes reported.""Isolated spontaneous reports of bronchospasm and anaphylactic shock have been received; and in the post marketing experience, liver function test abnormalities and skin reactions such as rash have been reported."

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