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Thursday 26 July 2007
Revised Labeling Approved for Lisinopril brands Zestril and Zestoretic
The FDA has approved revised Warnings and Precautions sections for AstraZeneca Pharmaceuticals’ Zestril (lisinopril) and Zestoretic (lisinopril/hydrochlorothiazide).
The revised sections include information based on a recently published article concerning angiotensin-converting enzyme (ACE) inhibitor use during the first trimester of pregnancy and a possible increased risk for major congenital malformations. Female patients of childbearing age should be apprised of the consequences of ACE inhibitor exposure during pregnancy and report pregnancies to their health care providers as soon as possible.