Cromolyn Pregnancy and Breast Feeding Warnings

Cromolyn is also known as: Gastrocrom, Intal, Intal Inhaler

Overview

If you are pregnant or plan on becoming pregnant, discuss with your doctor the benefits and risks of using Cromolyn Aerosol Solution during pregnancy. It is unknown if Cromolyn Aerosol Solution is excreted in breast milk. If you are or will be breast-feeding, check with your doctor to discuss the benefits and risks to your baby.

Cromolyn Pregnancy Warnings

Cromolyn has been assigned to pregnancy category B by the FDA. Animal studies using doses up to 338 times the normal human dose have revealed no evidence of teratogenicity. There are no controlled data in human pregnancies; however, data available suggest cromolyn use in human pregnancy is not associated with fetal toxicity or teratogenicity. Cromolyn is only recommended for use during pregnancy when benefit outweighs risk.

Evaluation of 296 women treated with cromolyn throughout pregnancy revealed 4 newborns with congenital malformations (1.35%), which is lower than the expected rate. The malformations included club foot, harelip, nonfused septum, and patent ductus arteriosus.

Cromolyn Lactation Warnings

There are no data on the excretion of cromolyn into human milk.

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