Phenylpropanolamine Pregnancy and Breastfeeding Warnings

Phenylpropanolamine is also known as: Acutrim 16 Hour, Acutrim II, Maximum Strength, Acutrim Late Day, Control, Dexatrim, Dexatrim Caffeine Free, Empro, Mega-Trim, Phenyldrine, Propagest, Propan, Rhindecon, Westrim, Westrim LA

Phenylpropanolamine Pregnancy Warnings

In a review of deliveries to Michigan Medicaid patients during 1980 to 1983, 1489 exposures to phenylpropanolamine any time during pregnancy were recorded. A total of 128 birth defects were reported (91 expected). An association was seen between phenylpropanolamine and laryngotracheal anomalies, pyloric stenosis, intestinal fixation anomalies, upper limb defects, skull/face anomalies, and musculoskeletal defects. The statistical significance of these associations is not known. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). The Collaborative Perinatal Project monitored 50,282 mother-child pairs and recorded 726 first-trimester exposures and 2489 exposures to phenylpropanolamine anytime during pregnancy. Possible associations between phenylpropanolamine and first trimester use and phenylpropanolamine include hypospadias (4), eye and ear abnormalities (7, statistically significant), polydactyly (6), cataract (3), and pectus excavatum (7). For use anytime during pregnancy a possible association was noted between phenylpropanolamine use and congenital dislocation of hip (12).

Phenylpropanolamine has been assigned to pregnancy category C. There are no controlled data in human pregnancy. Phenylpropanolamine should only be used during pregnancy when benefit outweighs the risk to the fetus.

Phenylpropanolamine Breastfeeding Warnings

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

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