Zafirlukast Pregnancy and Breast Feeding Warnings

Zafirlukast is also known as: Accolate

Overview

If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zafirlukast while you are pregnant. Zafirlukast is found in breast milk. Do not breast-feed while taking Zafirlukast .

Zafirlukast Pregnancy Warnings

Zafirlukast has been assigned to pregnancy category B by the FDA. Maternal toxicity and deaths in rats were seen at 800 times the maximum recommended human daily dose on a mg/m2 basis. There are no controlled data in human pregnancy. Zafirlukast is only recommended for use during pregnancy when benefit outweighs risk.

Zafirlukast Lactation Warnings

Zafirlukast is excreted into human milk. The manufacturer recommends that due to the potential for serious reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Animal studies have shown potential for tumorigenicity in mouse and rat studies and increased sensitivity in neonatal rats and dogs to the adverse effects of zafirlukast.

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