Label Changes for:
Edarbi (azilsartan medoxomil) Tablets
December 2011
Changes have been made to the WARNINGS, PRECAUTIONS and PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2011
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.
