MedWatch - February 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) -- February 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
Fansidar (sulfadoxine and pyrimethamine) Tablets (click product name to read prescribing information)	CONTRAINDICATIONS PRECAUTIONS General Information for the Patient Laboratory Tests Drug Interactions ADVERSE REACTIONS Skin and Miscellaneous Sites Allergic Reactions Respiratory Reactions Genitourinary Miscellaneous Reactions	Repeated prophylactic use of Fansidar is contraindicated in patients with renal or hepatic failure or with blood dyscrasias. Additional contraindications include: . Hypersensitivity to pyrimethamine, or sulfonamides, or any other ingredient of Fansidar; . Patients with documented megaloblastic anemia due to folate deficiency; . Infants less than 2 months of age; . Prophylactic use of Fansidar in pregnancy at term and during the nursing period.

Methadone Hydrochloride Injection (click product name to read prescribing information)	CONTRAINDICATIONS BOXED WARNINGS WARNINGS PRECAUTIONS ADVERSE REACTIONS	Extensive revisions to the prescribing information, container and carton. Please see prescribing information for new text.

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Advil Liqui-Gels (200mg ibuprofen) Advil Migraine (200mg ibuprofen) Capsules (click product name to read prescribing information)	WARNINGS	Stomach bleeding warning: Taking more than recommended may cause stomach bleeding. Ask a doctor before use if you have: Stomach problems that last or come back, such as heartburn, upset stomach, or pain Ulcers Bleeding problems High blood pressure, heart or kidney disease, are taking a diuretic, or are over 65 years of age.

Dextrose Injections (click product name to read prescribing information)	WARNINGS PRECAUTIONS Laboratory Tests Drug Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy - Teratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use	Dextrose Injection USP 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 phosphorous 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 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.

Mavik (trandolapril) Tablets Please contact Abbott Laboratories at 1-800-633-9110 for prescribing information.	WARNINGS Head and Neck Angioedema Intestinal Angioedema	Angioedema heading revised to read "Head and Neck 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.

Zometa (zoledronic acid) Injection (click product name to read prescribing information)	WARNINGS PRECAUTIONS General Renal Insufficiency ADVERSE REACTIONS Renal Toxicity Table 11	Zometa treatment is not recommended in patients with bone metastases with severe renal impairment. In clinical studies, patients with serum creatinine >265 µmol/L or >3.0 mg/dL were excluded and there were only eight of 564 patients treated with Zometa 4 mg by 15-minute infusion with a baseline creatinine > 2 mg/dL.

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Brand (Generic) Name	Sections Modified
Actonel (risedronate sodium) Tablets (click product name to read prescribing information)	PRECAUTIONS Pregnancy

Didronel (etidronate disodium) Tablets (click product name to read prescribing information)	PRECAUTIONS Pregnancy: Teratogenic Effects

Doryx (coated doxycycline hyclate pellets) Please contact F.H. Faulding & Company c/o Warner Chilcott, Inc at 973-442-3200 for prescribing information.	SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria. PRECAUTIONS General Information for Patients

Edecrin (ethacrynic acid) Tablets Intravenous Sodium Edecrin (ethacrynate sodium) (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Eryc (erythromycin base) Delayed-Release Capsules Please contact F.H. Faulding & Company c/o Warner Chilcott, Inc at 973-442-3200 for prescribing information.	SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria. PRECAUTIONS General Information for Patients

Fosamax (alendronate sodium) Tablets and Oral Solution (click product name to read prescribing information)	PRECAUTIONS Pregnancy

Glucagon for Injection (rDNA origin) (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Hydrea (hydroxyurea capsules) (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Intal (cromolyn sodium inhalation aerosal) Inhaler (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Intal (cromolyn sodium inhalation solution) Nebulizer Solution (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Manganese Chloride Injection Please contact Abbott Laboratories at 1-800-633-9110 for prescribing information.	PRECAUTIONS Geriatric Use

Mephyton (phytonadione) Tablets (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Mexitil (mexiletine hydrochloride) Capsules (click product name to read prescribing information)	PRECAUTIONS Drug Interactions ADVERSE REACTIONS Hematology

Mustargen (mechlorethamine HCl for Injection) (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Neoral Soft Gelatin Capsules (cyclosporine capsules) Neoral Oral Solution (cyclosporine oral solution) Modified (click product name to read prescribing information)	PRECAUTIONS Other Drug Interactions Geriatric Use

Pediazole (erythromycin ethylsuccinate and sulfisoxazol acetyl for oral suspension) Oral Suspension Please contact Ross Products Division, Abbott Laboratories at 1-800-986-8510 for prescribing information.	SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria. PRECAUTIONS General Information for Patients Geriatric Use

Renagel (sevelamer hydrochloride) Tablets and Capsules (click product name to read prescribing information)	PRECAUTIONS Drug Interactions Iron Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy ADVERSE REACTIONS

Sandimmune (cyclosporine injection) Injection Sandimmune (cyclosporine oral solution) Oral Solution Sandimmune (cyclosporine capsules) Soft Gelatin Capsules (click product name to read prescribing information)	PRECAUTIONS Other Drug Interactions Geriatric Use

Semprex-D (acrivastine and pseudoephedrine) Capsules Please contact Celltech Pharmaceutical, Inc. at 1-800-234-5535 for prescribing information.	PRECAUTIONS Geriatric Use

Stromectal (ivermectin) Tablets (click product name to read prescribing information)	PRECAUTIONS General Difficulty in Standing/Walking ADVERSE REACTIONS Onchocerciasis Toxic Epidermal Necrolysis

Tilade (nedocromil sodium inhalation aerosol) Inhaler (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Vfend I.V. (voriconazole) for Injection Vfend (voriconazole) Tablets and Oral Suspension (click product name to read prescribing information)	PRECAUTIONS Information for Patients

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Brand (Generic) Name	Sections Modified
Agenerase Capsules and Oral Solution (click product name to read prescribing information)	ADVERSE REACTIONS Concomitant Therapy with Ritonavir Table 10 Table 11

Pletal (cilostazol) Tablets Please contact Otsuka America Pharmaceutical, Inc. at 1-800-562-3974 for prescribing information.	ADVERSE REACTIONS Postmarketing Experience The following adverse events have been reported worldwide since the launch of Pletal in the US: pain, chest pain, hot flushes, cerebral hemorrhage, angina pectoris, hypotension, hepatic dysfunction/abnormal liver function tests, jaundice, vomiting, thrombocytopenia, leukopenia, bleeding tendency, paresthesia, hyperglycemia, pulmonary hemorrhage, interstitial pneumonia, pruritus, skin eruptions including Stevens-Johnson syndrome, rash, increase BUN, and hematuria. The following adverse events occurred outside the US prior to marketing of Pletal in the US: pulmonary hemorrhage and Stevens-Johnson syndrome.

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