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

Invirase (saquinavir mesylate) Capsules and Tablets 

(click product name to read prescribing information)

WARNINGS

• Interaction with Rifampin

• Drug Interactions
  • Table 5
    • Antimycobacterial Agents
      •  Rifampin
  • Table 6
    • HIV Protease Inhibitor
      • Atazanavir
    • HIV Protease Inhibitor
      • Lopinavir/Ritonavir (conformulated capsule)

CONTRAINDICATIONS

Invirase/ritonavir should not be given together with rifampin, due to the risk of severe hepatocellular toxicity if the three drugs are given together.

WARNINGS

Rifampin should not be administered in patients taking ritonavir-boosted Invirase as part of an ART regimen due to the risk of severe hepatocellular toxicity observed in a drug-drug interaction study in healthy volunteers.

ParaGard T 380A Intrauterine Copper Contraceptive

(click product name to read prescribing information)

WARNINGS

• Intrauterine Pregnancy
• Ectopic Pregnancy
• Pelvic Infection
• Immunocompromise
• Embedment
• Perforation
• Expulsion
• Wilson’s Disease

PRECAUTIONS

• Information for Patients
• Vaginal Bleeding
• Vasovagal Reactions, including Fainting
• Expulsion following Placement after a Birth or Abortion
• Magnetic Resonance Imaging (MRI)
• Medical Diathermy
• Pregnancy
• Nursing Mothers
• Pediatric Use

ADVERSE REACTIONS

• Initial Section
• Table 2
• The following adverse events ..... 

INSTRUCTIONS FOR USE

PATIENT PACKAGE INSERT

CONTRAINDICATIONS

• Acute pelvic inflammatory disease, or current behavior suggesting a high risk for pelvic inflammatory disease
• Postpartum endometritis or postabortal endometritis in the past 3 months
• Mucopurulent cervicitis
• Allergy to any component of ParaGard
• A previously placed IUD that has not been removed

WARNINGS

Please see the prescribing information for details on the following subsections:

• Intrauterine Pregnancy
• Ectopic Pregnancy
• Pelvic Infection
• Immunocompromise
• Embedment
• Perforation
• Expulsion
• Wilson’s Disease

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Zevalin (ibritumomab tiuxetan)

(click product name to read prescribing information)

• Severe Cutaneous and Mucocutaneous Reactions

WARNINGS

• Severe Cutaneous and Mucocutaneous Reactions

ADVERSE REACTIONS

• The most serious adverse reactions caused by the Zevalin therapeutic regimen include.....  

• Post-marketing Reports
  • Cutaneous and Mucocutaneous Reactions 

BOXED WARNING 

Severe cutaneous and mucocutaneous reactions, some with fatal outcome, have been reported in association with the Zevalin therapeutic regimen. Patients experiencing a severe cutaneous or mucocutaneous reaction should not receive any further component of the Zevalin therapeutic regimen and should seek prompt medical evaluation. 

WARNINGS

There have been postmarketing reports of erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous dermatitis, and exfoliative dermatitis in patients who received the Zevalin therapeutic regimen. Some of these events were fatal. The onset of the reactions was variable; in some cases, acute, (days) and in others, delayed (3-4 months). Patients experiencing a severe cutaneous or mucocutaneous reaction should not receive any further components of the Zevalin therapeutic regimen and should seek prompt medical evaluation.

For additional details, see MedWatch 10/28/2005 Safety Alert.

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Erbitux (cetuximab) for Intravenous Use

(click product name to read prescribing information)

• Infusion Reactions

PRECAUTIONS

• Laboratory Tests
  •  Electrolyte Monitoring

ADVERSE REACTIONS

• Electrolyte Depletion
  • Hypomagnesemia

.....A 1-hour observation period is recommended following the Erbitux infusion. Longer observation periods may be required in patients who experience infusion reactions.

For additional details, see MedWatch 09/14/2005 Safety Alert.

Elcon (mometasone furoate) Lotion, 0.1%

(click product name to read prescribing information)

Hep-Lock  U/P Preservative-Free (Heparin Lock Flush Solution, USP)

(click product name to read prescribing information)

• Use in Neonates and Infants

PRECAUTIONS

• General

The 100 unit/mL concentration should not be used in neonates or in infants who weigh less than 10 kg because of the risk of systemic anticoagulation. Caution is necessary when using the 10 unit/mL concentration in premature infants who weigh less than 1 kg who are receiving frequent flushes since a therapeutic heparin dose may be given to the infant in a 24-hour period.

Actiq (oral transmucosal fentanyl citrate)

(click product name to read prescribing information)

• Information for the Patients and Their Caregivers

PATIENT PACKAGE INSERT

(click product name to read prescribing information)

• General
  • Osteonecrosis of the Jaw
• Musculoskeletal Pain
• Glucocorticoid-Induced Osteoporosis

• Information for Patient

ADVERSE REACTIONS

• Post-marketing Experience
  • Musculoskeletal

PATIENT PACKAGE INSERT

(click product name to read prescribing information)

• Geriatric Use

ADVERSE REACTIONS

• Adjuvant Therapy
  • Table 9
    • Ischemic Cardiovascular Disease

Cordarone (amiodarone hydrochloride) Intravenous

(click product name to read prescribing information)

• Drug Interactions
  • CYP3A4 and p-glycoprotein
  • Other Substances
    • Inhibits p-glycoprotein and certain CYP450 Enzymes...

ADVERSE REACTIONS

• Postmarketing Reports
  • Renal Impairment
  • Renal Insufficiency
  • Acute Renal Failure
  • Agranulocytosis

Coumadin  Tablets (warfarin sodium tablets, USP) Crystalline 

Coumadin for Injection (warfarin sodium for injection, USP)

(click product name to read prescribing information)

• Exogenous Factors Table
  • Classes of Drugs
    • Proton Pump Inhibitors
  • Specific Drugs Reported
    • Esomeprazole
    • Gefitinib
    • Lansoprazole
    • Oxandrolone
    • Pantoprazole
    • Rabeprazole
• Botanical (Herbal) Medicines
  • Ginkgo Biloba & Cranberry Products
• Information for Patients
  • Cranberry Juice

Emtriva (emtricitabine) Capsules and Oral Solution

(click product name to read prescribing information)

• Drug Interactions
  • Zidovudine
• Immune Reconstitution Syndrome
• Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Carcinogenesis
• Pediatric Use

ADVERSE REACTIONS

• Pediatric Patients

(click product name to read prescribing information)

• Drug Interactions

  • Ergotism

Minocin (minocycline hydrochloride) Oral Suspension 

Please contact Wyeth Pharmaceuticals at 1-800-934-5556 for prescribing information.

• Drug Interactions

  • Ergotism

Increased risk of ergotism when ergot alkaloids or their derivatives are given with tetracyclines.

(click product name to read prescribing information)

• Drug Interactions

  • Ergotism

(click product name to read prescribing information)

• General
• Laboratory Tests
• Pediatric Use

(click product name to read prescribing information)

• Geriatric Use

ADVERSE REACTIONS

• Initial Paragraph
  • Ulcerative Colitis
• Infections
  • Ulcerative Colitis
• Hepatotoxicity
  • Table 9
• Other Adverse Reactions

PATIENT PACKAGE INSERT

Sandostatin (octreotide acetate) Injection

(click product name to read prescribing information)

• General
• Drug Interactions 
  • Bromocriptine 
  • Cytochrome P450 & CYP3A4 Metabolism
• Geriatric Use

ADVERSE REACTIONS

• Gastrointestinal

Viracept (nelfinavir mesylate) Tablets and Oral Powder

(click product name to read prescribing information)

• Immune Reconstitution Syndrome
• Drug Interactions
  • Inhaled/Nasal Steroid  
    • Fluticasone
  • Antidepressant  
    • Trazodone

(click product name to read prescribing information)

Please note throughout the labeling, chronic renal failure (CRF) has been replaced with "chronic kidney disease (CKD) Stage 5."

PRECAUTIONS

• Drug Interactions
• Carcinogenesis, Mutagenesis, Impairment of Fertility
• Nursing Mothers

ADVERSE REACTIONS

• Adverse Events During Post-marketing Experience
  • Facial and Oral Edema

Zosyn (piperacillin and tazobactam for injection) 

(click product name to read prescribing information)

• Precautions
  • General
    • Sodium 
• Drug Interactions
  • Aminoglycosides
• Geriatric Use

(click product name to read prescribing information)

• Dermatologic Reactions
• Hematologic Reactions
• Metabolic Reactions

Please contact The Medicines Company at 1-800-ANGIOMAX for prescribing information.

• Post-marketing Events 

The following events have been reported: fatal bleeding; hypersensitivity and allergic reactions including very rare reports of anaphylaxis; thrombus formation during PCI with and without intracoronary brachytherapy, including reports of fatal outcomes.

Argatroban Injection

(click product name to read prescribing information)

• Adverse Events Reported in Other Populations
  • Intracranial Bleeding

Flovent Diskus (fluticasone propionate inhalation powder)

(click product name to read prescribing information)

• Observed During Clinical Practice
  • Psychiatry
    • Anxiety
    • Behavioral Changes

Lipitor (atorvastatin calcium) Tablets

(click product name to read prescribing information)

• Collaborative Atorvastatin Diabetes Study (CARDS)
• Postintroduction Reports
  • Fatigue

Lupron Injection (leuprolide acetate)

(click product name to read prescribing information)

• Post-marketing 
  • Pituitary Apoplexy

(click product name to read prescribing information)

• Post-marketing 
  • Pituitary Apoplexy

Lupron Depot 7.5 mg (leuprolide acetate for depot suspension)

• Post-marketing 
  • Pituitary Apoplexy

Lupron Depot - 3 Month 11.25 mg (leuprolide acetate for depot suspension)

(click product name to read prescribing information)

• Post-marketing
  • Pituitary Apoplexy

Lupron Depot - 4 Month 30 mg (leuprolide acetate for depot suspension)

(click product name to read prescribing information)

• Post-marketing
  • Pituitary Apoplexy

Micardis (telmisartan) Tablets

(click product name to read prescribing information)

• Post-marketing Experience 

Micardis HCT (telmisartan/hydrochlorothiazide) Tablets

(click product name to read prescribing information)

• Telmisartan 
  • Post-marketing Experience 

(click product name to read prescribing information)

ADVERSE REACTIONS

• In the CAMELOT and PREVENT studies .....

Please contact Axcan Scandipharm Inc. at 1-800-742-6706 for prescribing information.

• Fluid Imbalance
• Cataracts

A few cases of fluid imbalance have been reported following the use of photodynamic therapy (PDT) with Photofrin in patients with overtly disseminated intraperitoneal malignancies. Fluid imbalance is an expected PDT treatment-related event.

A case of cataracts has been reported in a 51 year-old obese man treated with Photofrin for high-grade dysplasia HGD in Barrett’s Esophagus (BE). The patient suffered from a PDT response with development of a deep esophageal ulcer. Within two months post PDT, the patient response noted difficulty with his distant vision. A thorough eye examination revealed a change in the refractive error that later progressed to cataracts in both eyes. Both of his parents had a history of cataracts in their 70s. Whether Photofrin directly caused or accelerated a familial underlying condition is unknown.

Viadur  (leuprolide acetate implant)

(click product name to read prescribing information)

• Post-marketing
  • Pituitary Apoplexy

Xenical (orlistat) Capsules

(click product name to read prescribing information)

• Other Clinical Studies or Postmarketing Surveillance

FDA/CDER/OCD/Safety Policy and Communication Staff
Web page last revised by jlw November 30, 2005