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Cromolyn Pregnancy and Breastfeeding Warnings

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

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.

See references

Cromolyn Breastfeeding Warnings

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

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References for pregnancy information

  1. Wilson J "The use of sodium cromoglycate in pregnancy: results in 296 asthmatic women." Acta Therap 8 Suppl (1982): 45-51
  2. Mcdonald CF, Burdon JGW "Asthma in pregnancy and lactation - a position paper for the thoracic society of australia and new zealand." Med J Aust 165 (1996): 485-8
  3. "Product Information. Intal (cromolyn)." Rhone-Poulenc Rorer, Collegeville, PA.
  4. Dombrowski MP "Pharmacologic therapy of asthma during pregnancy." Obstet Gynecol Clin North Am 24 (1997): 559

References for breastfeeding information

  1. "Product Information. Intal (cromolyn)." Rhone-Poulenc Rorer, Collegeville, PA.
  2. Mcdonald CF, Burdon JGW "Asthma in pregnancy and lactation - a position paper for the thoracic society of australia and new zealand." Med J Aust 165 (1996): 485-8

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