Comment
Author: Admin | 2025-04-28
To require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out. References "Product Information. Xanax (alprazolam)." Pharmacia and Upjohn PROD (2002): "Product Information. Niravam (alprazolam)." Schwarz Pharma (2005): "Product Information. Xanax XR (alprazolam)." Pfizer U.S. Pharmaceuticals Group (2005): Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0 Cerner Multum, Inc. "Australian Product Information." O 0 The following applies to the ingredients: Lisinopril AU: Use is contraindicated.UK: Use is not recommended during the first trimester and use is contraindicated during the second and third trimesters.US: This drug should not be used during pregnancy unless there are no alternatives and the benefit outweighs the risk to the fetus.AU TGA pregnancy category: DUS FDA pregnancy category: Not assignedRisk Summary: Use of drugs that act on the renin angiotensin system (RAS) during the second and third trimesters of pregnancy increases fetal and neonatal morbidity and death.Comments:-Adequate methods of contraception should be encouraged.-Advise pregnant women and females of reproductive potential of the potential risk to a fetus.Animal studies have revealed evidence of fetotoxicity. In humans, exposure to angiotensin-converting enzyme (ACE) inhibitors during the second and third trimesters has revealed evidence of fetal and neonatal toxicity and fetolethality. There are no controlled data in human pregnancy.AU TGA pregnancy category D: Drugs which have caused, are suspected
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