Guaifenesin / pseudoephedrine Pregnancy and Breastfeeding Warnings
Guaifenesin / pseudoephedrine is also known as: Biotuss PE, Congestac, Decongest II, Drituss GP, Entex PSE, Eudal SR, Guaifenex PSE 120, Mastussin PE, Maxifed, Miraphen PSE, Mucinex D, Nalex, Nasabid, Nasatab LA, Profen II, Pseudovent, Pseudovent 400, Respaire-30, Respaire-60 SR, Robitussin Severe Congestion, Rymed, Sudafed Non Drying Sinus, Versacaps, Zephrex, Zephrex LA
Guaifenesin / pseudoephedrine Pregnancy Warnings
Guaifenesin-pseudoephedrine has been assigned to a pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Guaifenesin-pseudoephedrine is only recommended for use during pregnancy when benefit outweighs risk.
Pseudoephedrine: A case-controlled surveillance study reported an elevated relative risk (3.2) of gastroschisis with first-trimester pseudoephedrine use in 76 cases. Relative risks for other drugs were 1.6 for salicylates, 1.7 for acetaminophen, 1.3 for ibuprofen, and 1.5 for phenylpropanolamine (not significant). The authors hypothesized vascular disruption was the etiology of gastroschisis. A second group of 416 infants with heterogenous defects suspected to have a vascular etiology was studied. There was no increased risk associate with salicylates, ibuprofen, pseudoephedrine, phenylpropanolamine and other decongestants. These data require independent confirmation. In a review of 229,101 deliveries to Michigan Medicaid patients, 940 first-trimester exposures to pseudoephedrine and 1919 exposures any time during pregnancy were recorded. A total of 37 birth defects were reported with first trimester exposure (40 expected) and included (observed/expected) 3/9 cardiovascular defects, 2 oral clefts, and 3/2 polydactyly. These researchers reviewed nine cases of abdominal wall defects in the 1980-1983 Medicaid data compared to 3752 pseudoephedrine-exposed pregnancies. Seven of the nine cases had been exposed to pseudoephedrine providing a relative risk of 1.8. Only one case was a surgically treated abdominal wall defect. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994) The Collaborative Perinatal Project monitored 50,282 mother-child pairs. Only 39 first-trimester exposures to pseudoephedrine were recorded, with one birth defect observed. For use any time during pregnancy, 194 exposures were recorded with 3 birth defects observed (3.22 expected). The effect of pseudoephedrine on uterine and fetal blood was studied in 12 healthy pregnant women between 26 and 40 weeks gestation. Following a single 60-mg dose of pseudoephedrine, no significant effect was seen on fetal heart rate, uterine blood flow, or fetal aortic blood flow. Guaifenesin: 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 9 birth defects were reported with first trimester exposure (6 expected) and included 2 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 / pseudoephedrine Breastfeeding Warnings
There are no data on the excretion of guaifenesin into human milk. Pseudoephedrine is excreted 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.
Three mothers given pseudoephedrine demonstrated milk concentrations consistently higher than plasma concentrations. Maximum milk concentrations were reached at 1 to 1.5 hours after dosing. In one woman, the milk:plasma concentration ratio at 1, 3, and 12 hours was 3.3, 3.9, and 2.6, respectively. The authors calculated that 1000 mL of breast milk consumed over 24 hours would provide an infant with 0.25 to 0.33 mg of pseudoephedrine, or 0.5% to 0.7% of the dose ingested by the mother.
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