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U.S. Department of Health and Human Services

Safety

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Exforge (amlodipine and valsartan) Tablets July 2008


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

BOXED WARNING

  • WARNING: AVOID USE IN PREGNANCY

WARNINGS AND PRECAUTIONS

  • Fetal/Neonatal Morbidity and Mortality
  • Hypotension
  • Impaired Renal Function - Hypertension

DRUG INTERACTIONS

  • Drug/Food Interactions
    • Studies with Exforge
      • The bioavailabilities of amlodipine and valsartan are not altered by the co-administration of food.

USE IN SPECIFIC POPULATIONS

  • Pregnancy
    • Pregnancy Category D
  • Nursing Mothers
    • ...Valsartan was excreted into the milk of lactating rats; however, animal breast milk drug levels may not accurately reflect human breast milk levels...
  • Geriatric Use
    • Initial Paragraph
    • Amlodipine
    • Valsartan

PATIENT PACKAGE INSERT

  • What is the most important information I should know about Exforge?
  • What is Exforge?
  • What should I tell my doctor before taking Exforge?
  • How should I take Exforge?
  • What are the possible side effects of Exforge?
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • What is high blood pressure (hypertension)?

BOXED WARNING

WARNING: AVOID USE IN PREGNANCY
When pregnancy is detected, discontinue Exforge as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. [See Warnings and Precautions (5.1)]

WARNINGS AND PRECAUTIONS

Fetal/Neonatal Morbidity and Mortality

Exforge can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Drugs that act on the renin angiotensin system can cause fetal and neonatal morbidity and mortality when used in pregnancy. In several dozen published cases, ACE inhibitor use during the second and third trimesters of pregnancy was associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death [see Use in Specific Populations (8.1)].

Hypotension

...Volume depletion should be corrected prior to administration of Exforge. Treatment with Exforge should start under close medical supervision...

Impaired Renal Function - Hypertension

...As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may occur particularly in volume depleted patients...