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Brompheniramine / pseudoephedrine Pregnancy and Breastfeeding Warnings

Brompheniramine / pseudoephedrine is also known as: Allent, B-Vex PD, Bidhist-D, Brofed, Bromaline, Bromfed PD, Bromfed SR, Bromhist Pediatric, Brotapp, BroveX PD, BroveX PSB, BroveX PSE, Dimaphen, Dimetapp Elixir, Endafed, LoHist PSB, LoHist-12D, Lodrane, Lodrane 12D, Lodrane 24D, Lodrane D, Lodrane LD, Q-Tapp, Rynex PSE, Touro A&H

Brompheniramine / pseudoephedrine Pregnancy Warnings

Brompheniramine: The Collaborative Perinatal Project monitored 65 first trimester exposures to brompheniramine. Malformations were reported in 10 infants, a statistically significant association. In another 6509 live births, 172 mothers were exposed to Dimetapp (brompheniramine, phenylephrine and phenylpropanolamine). Five infants were born with congenital abnormalities resulting in a somewhat higher frequency than normal. 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 heterogeneous defects suspected to have a vascular etiology was reviewed. There was no increased risk associated 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 anytime 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, providing a relative risk of 1.8. Seven of the nine cases had been exposed to pseudoephedrine and of these 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 anytime 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.

Brompheniramine-pseudoephedrine has been assigned to pregnancy category C by the FDA. Animal reproduction studies have not been performed on brompheniramine-pseudoephedrine. There are no controlled data in human pregnancy. Brompheniramine-pseudoephedrine should only be given during pregnancy when benefits outweigh risks.

Brompheniramine / pseudoephedrine Breastfeeding Warnings

Brompheniramine-pseudoephedrine is excreted into human milk. Because of the higher than usual risk for infants from sympathomimetic amines, use of this product by nursing mothers is contraindicated.

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