Edarbi (azilsartan medoxomil) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
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
- 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.
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.
- Muscle spasms
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)
- 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 Category D
PATIENT COUNSELING INFORMATION (revised)
- 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.