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U.S. Department of Health and Human Services

Safety

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Altace (ramipril) 1.25, 2.5, 5, and 10 mg Capsules March 2009

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- March 2009

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

Sections Modified

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS

  • Fetal/Neonatal Morbidity and Mortality

PRECAUTIONS

  • Information for Patients/Pregnancy
    • Female patients of childbearing age should be told about the consequences of exposure to ACE inhibitors during pregnancy. These patients should be asked to report pregnancies to their physicians as soon as possible.

WARNINGS

  • Fetal/Neonatal Morbidity and Mortality
    • In a published retrospective epidemiological study, infants whose mothers had taken an ACE inhibitor during their first trimester of pregnancy appeared to have an increased risk of major congenital malformations...findings of this study have not yet been confirmed.

 

The latest label (approved 03/04/2009) is not available on this site