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.

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Ellence (epirubicin hydrochloride) Injection

(click product name to read prescribing information)

WARNINGS

PRECAUTIONS

• General

Patients should not be treated with Ellence Injection if they have any of the following conditions: baseline neutrophil count < 1500 cells/mm3; severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias; previous treatment with anthracyclines up to the maximum cumulative dose; hypersensitivity to epirubicin, other anthracyclines, or anthracenediones; or severe hepatic dysfunction (see WARNINGS and DOSAGE AND ADMINISTRATION).

Before beginning treatment with epirubicin, patients should recover from acute toxicities (such as stomatitis, neutropenia, thrombocytopenia, and generalized infections) of prior cytotoxic treatment.

Refludan [lepirudin (rDNA)] for Injection

(click product name to read prescribing information)

WARNINGS

• Hemorrhagic Events

PRECAUTIONS

• General
  • Reexposure
  • Allergic Reactions

ADVERSE REACTIONS

• Adverse Events Reported in Clinical Trials in HIT Patients
• Adverse Events Reported in Clinical Trials in Other Populations
  • Intracranial Bleeding
• Adverse Events from Post Marketing Reports

Refludan is contraindicated in patients with known hypersensitivity to hirudins or to any of the components in Refludan [lepirudin (rDNA) for injection].

Hemorrhagic Events:  As with other anticoagulants, hemorrhage can occur at any site in patients receiving Refludan. An unexpected fall in hemoglobin, fall in blood pressure or any unexplained symptom should lead to consideration of a hemorrhagic event. While patients are being anticoagulated with Refludan, the anticoagulation status should be monitored closely using an appropriate measure such as the aPTT (see ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION: Monitoring Section.)

There have been reports of intracranial bleeding with Refludan the absence of concomitant thrombolytic therapy (see ADVERSE REACTIONS.)

Soriatane (acitretin) Capsules

(click product name to read prescribing information)

BOXED CONTRAINDICATIONS AND WARNINGS

• Important Information for Males Taking Soriatane

WARNINGS

• For Prescribers
  • Drug Interactions

PRECAUTIONS

• Geriatric Use

ADVERSE REACTIONS

PATIENT AGREEMENT/INFORMED CONSENT FOR FEMALE PATIENTS

MEDICATION GUIDE

PREGNANCY PREVENTION PROGRAM BOOKLET

Numerous changes to stated sections.  Please see prescribing information.

Targretin (bexarotene) Capsules

(click product name to read prescribing information)

• Pregnancy:  Category X

PRECAUTIONS

• Drug-Drug Interactions

PATIENT PACKAGE INSERT

Bexarotene can potentially induce metabolic enzymes and thereby theoretically reduce the plasma concentrations of oral or other systemic hormonal contraceptives (see CLINICAL PHARMACOLOGY: Drug-Drug Interactions and PRECAUTIONS: Drug-Drug Interactions). Thus, if treatment with Targretin capsules is intended in a woman with child-bearing potential, it is strongly recommended that one of the two reliable forms of contraception should be non-hormonal.

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Ancobon  (flucytosine) Capsules

(click product name to read prescribing information)

PRECAUTIONS

• Drug Interactions
• Drug/Laboratory Test Interactions
• Carcinogenesis, Mutagenesis, Impairment of Fertility
• Pregnancy
• Pediatric Use

ADVERSE REACTIONS

• Cardiovascular
• Gastrointestinal
• Psychiatric

Bone marrow toxicity can be irreversible and may lead to death in immunosuppressed patients.

Cordarone (amiodarone hydrochloride) Tablets

Please contact Wyeth Pharmaceuticals at 1-800-395-9938 for prescribing information.

• Pulmonary Toxicity

ADVERSE REACTIONS

• Postmarketing Reports

There have been postmarketing reports of acute-onset (days to weeks) pulmonary injury in patients treated with oral Cordarone with or without initial I.V. therapy.  Findings have included pulmonary infiltrates on X-ray, bronchospasm, wheezing, fever, dyspnea, cough, hemoptysis, and hypoxia.  Some cases have progressed to respiratory failure and/or death.

Patients with preexisting pulmonary disease have a poorer prognosis if pulmonary toxicity develops.

Reports suggest that the use of lower loading and maintenance doses of Cordarone are associated with a decreased incidence of Cordarone-induced pulmonary toxicity.

Nubain (nalbuphine hydrochloride) Injection

(click product name to read prescribing information)

• Use in Pregnancy (Other Than Labor)

• Use During Labor and Delivery

PRECAUTIONS

• Information for Patients
• Laboratory Tests
• Carcinogenesis, Mutagenesis, Impairment of Fertility
• Usage in Pregnancy
  • Teratogenic Effects - Pregnancy Category B
  • Non-Teratogenic Effects

ADVERSE REACTIONS

• Post-marketing

Severe fetal bradycardia has been reported when Nubain is administered during labor. Naloxone may reverse these effects. Although there are no reports of fetal bradycardia earlier in pregnancy, it is possible that this may occur. This drug should be used in pregnancy only if clearly needed, if the potential benefit outweighs the risk to the fetus, and if appropriate measures such as fetal monitoring are taken to detect and manage any potential adverse effect on the fetus.

(click product name to read prescribing information)

PRECAUTIONS

• Lipids
• Renal Function
• Interstitial Lung Disease
• Laboratory Tests
• Cyclosporine capsules MODIFIED
  • Rapammune Oral Solution
• Other Drug Interactions
  • Herbal Preparations
  • Carcinogenesis, Mutagenesis, and Impairment of Fertility
  • Pregnancy
    • Pregnancy Category C

ADVERSE REACTIONS

• Rapamune Oral Solution
• Rapamune Tablets
• Rapamune following cyclosporine withdrawal
• Other Clinical Experience

Renal function should be closely monitored during the administration of Rapamune in combination with cyclosporine since long-term administration can be associated with deterioration of renal function. Appropriate adjustment of the immunosuppression regimen, including discontinuation of Rapamune and/or cyclosporine, should be considered in patients with elevated or increasing serum creatinine levels.

(click product name to read prescribing information)

• Neuroleptic Malignant Syndrome (NMS)

PRECAUTIONS

• General
• Geriatric Use
• Other Special Populations

ADVERSE REACTIONS

• Neuroleptic Malignant Syndrome

Please contact B. Braun Medical Inc. at 1-800-854-6851 for prescribing information.

PRECAUTIONS

• General
• Carcinogenesis, Mutagenesis, Impairment of Fertility
• Pregnancy - Teratogenic Effects - Pregnancy Category C
• Nursing Mothers
• Pediatric Use
• Geriatric Use

ADVERSE REACTIONS

Hyperglycemia from metabolism of sorbitol may occur in patients with diabetes mellitus. 

Hyperlactatemia from metabolism of sorbitol may potentially produce a significant lactic acidemia in metabolically compromised patients.

(click product name to read prescribing information)

• Angioedema
  • Head and Neck Angioedema
• Intestinal Angioedema

PRECAUTIONS

• Geriatric Use

ADVERSE REACTIONS

• Angioedema

Intestinal 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.

(click product name to read prescribing information)

• Liver Dysfunction

PRECAUTIONS

• Geriatric Use

ADVERSE REACTIONS

• Heart Protection Study
  •  Clinical Adverse Experiences

Aclovate (alclometasone dipropionate) Cream and Ointment

(click product name to read prescribing information)

• Geriatric Use

(click product name to read prescribing information)

• Geriatric Use

Please contact Baxter Healthcare at 1-800-933-0303 for prescribing information.

• Nursing Mothers
  • It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 4% BranchAmin (branch chained amino acid) Injection is administered to a nursing mother.
• Geriatric Use

Econopred (prednisoloneacetate ophthalmic suspension)

Econopred Plus (prednisolone acetate ophthalmic suspension)

(click product name to read prescribing information)

• Geriatric Use

Fansidar (sulfadoxine and pyrimethamine) Tablets

(click product name to read prescribing information)

• Geriatric Use

Flagyl 375 (metronidazole) Capsules

Flagyl ER (metronidazole) Extended Release Tablets

Flagyl (metronidazole) Tablets

(click product name to read prescribing information)

• Geriatric Use

(click product name to read prescribing information)

• Geriatric Use

(click product name to read prescribing information)

PRECAUTIONS

• Drug Interactions
  • Lithium

Please contact Bristol-Myers Squibb at 212-546-4000 for prescribing information.

• Geriatric Use

Nebcin (tobramycin sulfate) Injection Vials and Hyporets 

Nebcin (tobramycin sulfate) for Injection Vials

Please contact Eli Lilly at 1-800-545-5979 for prescribing information.

• Geriatric Use

(click product name to read prescribing information)

• Carcinogenesis, Mutagenesis,and Impairment of Fertility

• Pregnancy

(click product name to read prescribing information)

PRECAUTIONS

• Drug Interactions
  • Anticoagulants
    • Warfarin

(click product name to read prescribing information)

• Geriatric Use

Potassium Chloride in 5% Dextrose and Sodium Chloride Injection

(click product name to read prescribing information)

• Pediatric Use

20% Pro-Sol-sulfite-free (amino acid) Injection in Viaflex plastic container.

Please contact Baxter Healthcare at 1-800-933-0303 for prescribing information.

• Nursing Mothers

  It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for adverse reactions, e.g., hyperammonemia in nursing infants, caution should be exercised when 20% ProSol sulfite-free (amino acid) Injection is administered to a nursing mother.

• Geriatric Use

Please contact Baxter Healthcare at 1-800-933-0303 for prescribing information.

• Nursing Mothers

  It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for adverse reactions, e.g., hyperammonemia in nursing infants, caution should be exercised when RenAmin (amino acid) Injection is administered to a nursing mother.

• Geriatric Use

Temovate (clobetasol propionate) Cream and Ointment

Temovate (clobetasol propionate) Scalp Application

(click product name to read prescribing information)

• Geriatric Use

Topamax (topiramate) Sprinkle Capsules

Please contact Ortho-McNeil Pharmaceuticals at 1-877-323-2200 for prescribing information.

• Other Drug Interactions
  • Oral Contraceptives

ADVERSE REACTIONS

• Postmarketing and Other Experience

(click product name to read prescribing information)

PRECAUTIONS

• Drug Interactions

(click product name to read prescribing information)

• Geriatric Use
  

(click product name to read prescribing information)

• General
• Drug Interactions
  • Methotrexate

ADVERSE REACTIONS

• Nosocomial Pneumonia Trials
• Postmarketing Experience
  • Gastrointestinal
  • Hematologic
  • Immune
  • Infections
  • Renal
  • Skin and Appendages
• Adverse Laboratory Events (Seen During Clinical Trials)
  • Additional laboratory events
  • Skeletal

(click product name to read prescribing information)

• Activities Requiring Mental Altertness

ADVERSE REACTIONS

• ZYRTEC-D 12 HOUR Extended Release Tablets
• Zyrtec Tablets

Atacand (candesartan cilexetil) Tablets

(click product name to read prescribing information)

• Post-Marketing Experience
  • Metabolic and Nutritional Disorders
  • Renal

Biaxin XL Filmtab  (clarithromycin extended-release tablets)

(click product name to read prescribing information)

• Post-marketing Experience

CardioTec (Kit for the Preparation of technetium Tc99m Teboroxime)

Please contact Bracco Diagnostics at 1-800-447-6883 for prescribing information.

Of the 1537 patients that were evaluated during the clinical development of CardioTec, 7 patients experienced serious adverse events of whom 4 patients had myocardial infarction, one each had hyperglycemia and arthralgia, and one patient experienced dizziness, nausea and lightheadedness. It was not possible to determine the underlying cause for these serious adverse events. 

In completed clinical trials, adverse events were evaluated in 1413 adults The most commonly reported non-serious adverse events were chest pain and nausea, both with the frequency of 0.4%. The following were adverse events by body systems: Body as a Whole (1.0%): back pain, chest pain, chest tightness, fatigue, injection site burning, injection site pain, shakiness; Cardiovascular (1.0%): angina, AV block, blood pressure decreased, blood pressure increased, flushing, heart rate decreased, hypertension, myocardial infarction, palpitation, postural hypotension; Gastrointestinal (0.6%): diarrhea, nausea, vomiting; Musculoskeletal (0.3%): arthralgia, jaw pain; Nervous (0.6%): balance disturbance, dizziness,hypoesthesia, paresthesia, syncope, taste disturbance; Respiratory (0.3%): dyspnea, wheezing; Skin and Appendages (0.2%): clamminess, dermatitis, face edema; Vision (0.1%): eye pain.

Noritate (metronidazole) Cream

(click product name to read prescribing information)

Primacor (milrinone lactate) Injection

Primacor (milrinone lactate) in 5% Dextrose Injection

(click product name to read prescribing information)

• Cardiovascular Effects
• Other Effects

(click product name to read prescribing information)

• Postmarketing Adverse Events

FDA/CDER/OCD/Safety Policy and Communication Staff
Web page last revised by jlw Aug 13, 2003