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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)   

 

July 2014

Summary View

PRECAUTIONS

Drug Interactions

Dual Blockade of the Renin-Angiotensin System (RAS)

  • Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors

Lithium

  • Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor. Monitor serum lithium levels during concomitant use.

 

April 2014

Summary View

6 ADVERSE REACTIONS   

6.3 Postmarketing Experience

The following adverse reactions have been identified during the postmarketing use of EDARBI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Nausea
  • Muscle spasms
  • Rash
  • Pruritus
  • Angioedema

 

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.