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U.S. Department of Health and Human Services

Safety

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Edarbi (azilsartan medoxomil) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2011

 

Summary View

 

BOXED WARNING

WARNING: FETAL TOXICITY

  • When pregnancy is detected, discontinue Edarbi as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

WARNINGS AND PRECAUTIONS (revised)

*Fetal toxicity

  • Use of drugs that act on the rennin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death…

 

USE IN SPECIFIC POPULATIONS (revised)

Pregnancy
  • Pregnancy Category D

 

PATIENT COUNSELING INFORMATION (revised)

General Information
  • Pregnancy: Tell female patients of childbearing potential about the consequences of exposure to Edarbi during pregnancy…

 

PATIENT PACKAGE INSERT (revised)

What is the most important information I should know about Edarbi?
  • Edarbi can cause harm or death to your unborn baby.
  • Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.
  • If you become pregnant while taking Edarbi, tell your doctor right away. Your doctor may switch you to a different medicine to treat your high blood pressure.