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Ibuprofen / pseudoephedrine Pregnancy and Breastfeeding Warnings

Ibuprofen / pseudoephedrine is also known as: Advil Children's Cold, Advil Cold and Sinus, Advil Cold and Sinus Liqui-Gels, Dristan Sinus, Motrin Childrens Cold, Motrin Cold and Flu, Motrin IB Sinus, Motrin Sinus Headache, Sine-Aid IB

Ibuprofen / pseudoephedrine Pregnancy Warnings

Ibuprofen-pseudoephedrine has not been formally assigned to a pregnancy category by the FDA. Animal studies failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. While there are no literature reports linking the use of ibuprofen in pregnancy with birth defects, use late in pregnancy may cause premature closure of the ductus arteriosus and prolong labor and delivery. Ibuprofen should be avoided near term. Based on available data, pseudoephedrine is not thought to be teratogenic. Ibuprofen-pseudoephedrine is only recommended for use during pregnancy when benefit outweighs risk.

One manufacturer of ibuprofen has reported 50 in utero exposures to ibuprofen. Seven cases were reported retrospectively and included one-third trimester fetal death of unknown cause, one spontaneous abortion without evidence of abnormalities, anencephaly (N=1), petit mal seizures progressing to grand mal seizures (N=1), cerebral palsy (N=1), microphthalmia, nasal cleft, and mildly rotated palate (N=1), and tooth staining (N=1). Of the 43 prospective cases, 23 were followed to a normal delivery. Of the remaining cases, one ended in a stillbirth without abnormalities, one ended in a spontaneous abortion without abnormalities, and the remaining were lost to follow-up. A case controlled surveillance study reported an elevated relative risk (3.2) of gastroschisis with first-trimester pseudoephedrine use in 76 cases. Relative risk for other drugs was 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 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 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. 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 anytime during pregnancy, 194 exposures were recorded with 3 birth defects observed (3.22 expected). The effect of pseudoephedrine on uterine and fetal blood flow 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.

Ibuprofen / pseudoephedrine Breastfeeding Warnings

In one woman treated with ibuprofen 400 mg twice a day for two weeks, ibuprofen concentrations in milk were below the level of detection (less than 0.5 mcg/mL) at all times tested. The hydroxy and carboxy metabolites were also undetectable. In another study, ibuprofen concentrations in milk were below the level of detection (less than 1 mcg/mL) in all samples taken from 12 postpartum women receiving ibuprofen 400 mg every six hours for 24 hours. The authors conclude that a breast-feeding infant would ingest less than 1 mg ibuprofen per day. Three mothers given pseudoephedrine demonstrated milk concentrations consistently higher than plasma concentrations. Maximum milk concentrations were reached 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.

Ibuprofen has not been detected in human milk. Ibuprofen is considered compatible with breast-feeding by the American Academy of Pediatrics. Pseudoephedrine is excreted into human milk. There are no reports of adverse effects in infants who were exposed to pseudoephedrine by breast milk. The American Academy of Pediatrics considers pseudoephedrine to be compatible with breast-feeding.

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