Guaifenesin / phenylpropanolamine Pregnancy and Breastfeeding Warnings
Guaifenesin / phenylpropanolamine is also known as: Banex-LA, Coldloc-LA, Despec CR, Enomine LA, Ephensin-LA, Exgest LA, G-Vent, Guaifenex PPA 75, Guaipax, Guaivent, Guiatex LA, Guiavent ER, Lantex-LA, Maxcosin LA, Medex-LA, Naldecon-EX Pediatric, Nasahist LA, Partuss-LA, Phentex-LA, Phenylfenesin LA, Profen LA, Rymed-TR, Sinuvent, Stamoist LA, ULR-LA
Guaifenesin / phenylpropanolamine Pregnancy Warnings
Guaifenesin-phenylpropanolamine has been assigned to pregnancy category C by the FDA. There are no controlled data in human pregnancy. Guaifenesin-phenylpropanolamine is only recommended for use during pregnancy when benefit outweighs risk.
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). A possible 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 2,489 exposures to phenylpropanolamine anytime during pregnancy. Possible associations between phenylpropanolamine and first trimester use included hypospadias (4), eye and ear defects (7, statistically significant), polydactyly (6), cataracts (3), and pectus excavatum (7). For use anytime during pregnancy a possible association was noted between phenylpropanolamine use and congenital dislocation of hip (12).
The Collaborative Perinatal Project reported 197 first-trimester exposures to guaifenesin. Fourteen malformations were reported for a relative risk not significantly different from 1.0.
In a review of 229,101 deliveries to Michigan Medicaid patients, 141 first-trimester exposures to guaifenesin and 349 exposures any time during pregnancy were recorded. A total of nine birth defects were reported with first trimester exposure (six expected) and included two cardiovascular defects. These data do not support an association between guaifenesin and birth defects. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994)
Guaifenesin / phenylpropanolamine Breastfeeding Warnings
There are no data on the excretion of phenylpropanolamine or guaifenesin into human milk. The manufacturer recommends that due to the potential for serious adverse 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.
References for pregnancy information
- Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
- "Product Information. Humabid (guaifenesin)." Medeva Pharmaceuticals, Rochester, NY.
References for breastfeeding information
- Covington TR, Lawson LC, Young LL, eds. "Handbook of Nonprescription Drugs. 10th ed." Washington, DC: American Pharmaceutical Association (1993):