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Lotensin (Benazepril Hydrochloride) - FDA Alerts

 



FDA Alerts related to Lotensin (Benazepril)

FDA ALERT [06/2006]:  Blood pressure medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors) may be associated with increased risk of birth defects if taken during early pregnancy (first three months, or first trimester).

On June 8, 2006, the New England Journal of Medicine published an article reporting a study that showed babies whose mothers had taken an ACE inhibitor during the first three months of pregnancy had an increased risk of birth defects.  The number of birth defects was small, and the study has not been repeated.

Before this study, it was known that ACE inhibitors can harm an unborn baby when taken during the last six months of pregnancy (second and third trimester). 

If you are pregnant or planning to become pregnant and take a blood pressure medicine, talk with your healthcare professional.  High blood pressure is a condition that needs treatment.  Your healthcare professional can advise you on the blood pressure medicine that is best for you and your baby during pregnancy. 

This information reflects FDA’s preliminary analysis of data concerning these drugs. FDA is considering, but has not reached a final conclusion about, this information.  FDA intends to update this sheet when additional information or analyses become available.

For complete, up-to-date safety information by the FDA, see MedWatch

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