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

(click product name to read prescribing information)

• Head and Neck Angioedema

• Intestinal Angioedema

• Fetal/Neonatal Morbidity and Mortality

• General

• Drug Interactions

  • Non-steroidal Anti-inflammatory Agents

• Carcinogenesis, Mutagenesis, Impairment of Fertility

• Pediatric Use

• Body as a Whole

• Special Senses

• Miscellaneous

• Angioedema

• Pediatric Patients

• Clinical Laboratory Findings

  • Hemoglobin and Hematocrit

Zestril is contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an angiotensin converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema.

Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with angiotensin converting enzyme inhibitors, including Zestril.

Intestinal angioedema has been reported in patients treated with ACE inhibitors.

No teratogenic effects of lisinopril were seen in studies of pregnant rats, mice, and rabbits. 

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

(click product name to read prescribing information)

WARNINGS

• Lactic Acidosis/Severe Hepatomegaly with Steatosis

PRECAUTIONS

• General
• Drug Interactions
  • Antiretroviral Agents
  • Doxorubicin
  • Overlapping Toxicities
• Pregnancy
• Pediatric Use

ADVERSE REACTIONS

• Adults
• Pediatrics: Study ACTG 300
• Use for the Prevention of Maternal-Fetal Transmission of HIV
• Observed During Clinical Practice
  • Body as a Whole
  • Cardiovascular
  • Endocrine
  • Eye
  • Gastrointestinal
  • General
  • Hemic and Lymphatic
  • Hepatobiliary Tract and Pancreas
  • Musculoskeletal
  • Nervous
  • Respiratory
  • Skin
  • Urogenital

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including Retrovir and other antiretrovirals (see WARNINGS).

WARNINGS: Combivir and Trizivir are combination product tablets that contain zidovudine as one of their components. Retrovir should not be administered concomitantly with Combivir or Trizivir.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including zidovudine and other antiretrovirals. A majority of these cases have been in women. Obesity and prolonged exposure to antiretroviral nucleoside analogues may be risk factors. Particular caution should be exercised when administering Retrovir to any patient with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment with Retrovir should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).

(click product name to read prescribing information)

WARNINGS

• General
• Hepatic events
• Skin reactions

PRECAUTIONS

• Drug Interactions
  • Information for Patients

ADVERSE REACTIONS

• Adults
• Post Marketing Surveillance
  • Skin and Appendages

  PATIENT PACKAGE INSERT

It is essential that patients be monitored intensively during the first 18 weeks of therapy with Viramune to detect potentially life-threatening hepatotoxicity or skin reactions. The greatest risk of severe rash or hepatic events associated with rash occurs in the first six weeks of therapy. However, the risk of any hepatic event, with or without rash, continues past this period and monitoring should continue at frequent intervals.

Increased AST or ALT levels and/or co-infection with hepatitis B or C at the start of antiretroviral therapy are associated with a greater risk of hepatic adverse events. It appears that women and patients with higher CD4 counts (>250 cells/mm³ in women and >400 cells/mm³ in men) may be at higher risk for rash-associated hepatic events with Viramune.

If patients present with a suspected Viramune-associated rash, liver function tests should be performed. Patients with rash-associated AST or ALT elevations should be permanently discontinued from Viramune.

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

(click product name to read prescribing information)

• Pregnant Women with Mechanical Prosthetic Heart Valves
• Miscellaneous

PRECAUTIONS

• Mechanical Prosthetic Heart Valves

• Pregnancy:  Pregnancy Category B

  • Fetal Risk Summary

  • Clinical Considerations

  • Data

    • Human Data

    • Animal Data

Because benzyl alcohol may cross the placenta, Lovenox multiple-dose vials, preserved with benzyl alcohol, should be used with caution in pregnant women and only if clearly needed (see PRECAUTIONS, Pregnancy).

(click product name to read prescribing information)

• Labor and Delivery

  • Necrotizing enterocolitis in neonates (NEC)

(click product name to read prescribing information)

• Geriatric Use

(click product name to read prescribing information)

• General
  • Idiopathic short stature

ADVERSE REACTIONS

• Patients with Idiopathic Short Stature
• Table 7

Imitrex (sumatriptan) Tablets, Nasal Spray and Injection

(click product name to read prescribing information)

• General
  • Seizures

Lysodren (mitotane tablets)

(click product name to read prescribing information)

• Geriatric Use

Please contact Abbott Laboratories at 1-800-633-9110 for prescribing information.

• Pediatric Use

Nimbex has not been studied in pediatric patients below the age of one month (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION for clinical experience and recommendations for use in children one month to 12 years of age).  Intubation of the trachea in patients 1-4 years of old was facilitated more reliably when Nimbex was used in combination with Halothane than when opioids and nitrous oxide were used for induction of anesthesia.

ADVERSE REACTIONS

• Observed During Clinical Practice
  • General

There are rare reports of wheezing, laryngospasm, bronchospasm, rash and itching following administration of Nimbex in children. These reported adverse events were not serious and their etiology could not be established with certainty.

(click product name to read prescribing information)

• Drug Interactions
  • Stavudine and Zidovudine

Talacen (pentazocine HCl and acetaminophen) Caplets

Please contact Sanofi Synthelabo at 1-800-446-6267 for prescribing information.

• Geriatric Use

Detrol LA (tolterodine tartrate extended release capsules)

(click product name to read prescribing information)

• Postmarketing Surveillance
  • Hallucinations

(click product name to read prescribing information)

• Postmarketing Adverse Events
  • Cardiomyopathy

Zyprexa (olanzapine) Zydis Orally Disintegrating Tablets

(click product name to read prescribing information)

• Adverse Events Associated with Discontinuation of Treatment in Short-Term Combination Trials
  • Bipolar Mania Combination Therapy
• Commonly Observed Adverse Events in Short-Term, Placebo-Controlled Trials
• Commonly Observed Adverse Events in Short-Term Combination Trials

FDA/CDER/Office of Drug Safety
Web page last revised by jlw Oct 21, 2003