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Acetaminophen / brompheniramine / dextromethorphan / pseudoephedrine Pregnancy and Breastfeeding Warnings

Acetaminophen / brompheniramine / dextromethorphan / pseudoephedrine Pregnancy Warnings

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 were reviewed. There was no increased risk associated with salicylates, ibuprofen, pseudoephedrine, phenylpropanolamine or other decongestants. These data require independent confirmation. In a review of 229,101 deliveries to Michigan Medicaid patients, 940 first-trimester exposures to pseudoephedrine were recorded and 1919 exposures anytime during pregnancy. 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. Seven of the nine cases occurred in 3752 woman who had taken pseudoephedrine for a relative risk of 1.8. Only one of these cases 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.

Acetaminophen has not been formally assigned to a pregnancy category by the FDA. It is routinely used for short-term pain relief and fever in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations. Brompheniramine has been assigned to pregnancy category C by the FDA. Animal studies failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. 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. Dextromethorphan has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity. There are no controlled data in human pregnancy. Pseudoephedrine has not been formally assigned to a pregnancy category by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Based on available data, pseudoephedrine is not thought to be teratogenic. Acetaminophen/brompheniramine/dextromethorphan/pseudoephedrine is only recommended for use during pregnancy when benefit outweighs risk.

Acetaminophen / brompheniramine / dextromethorphan / pseudoephedrine Breastfeeding Warnings

Acetaminophen is excreted into human milk in small concentrations. One case of a rash has been reported in a nursing infant. There are no data on the excretion of brompheniramine into human milk. One case of irritability and sleep disturbances has been reported in an infant whose mother was prescribed brompheniramine and isoephedrine. There are no data on the excretion of dextromethorphan into human milk. Pseudoephedrine is excreted into human milk. The effects in the nursing infant are unknown. The American Academy of Pediatrics considers pseudoephedrine to be compatible with breast-feeding.

Based on the low molecular weight of dextromethorphan some passage into breast milk probably occurs. However, maternal use of dextromethorphan products that do not contain alcohol are probably safe to use during breast-feeding. 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. 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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