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Diphenhydramine / ibuprofen Pregnancy and Breastfeeding Warnings

Diphenhydramine / ibuprofen is also known as: Advil PM, Ibuprofen PM, Motrin PM

Diphenhydramine / ibuprofen Pregnancy Warnings

Diphenhydramine-ibuprofen has not been formally assigned to a pregnancy category by the FDA. Diphenhydramine has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal teratogenicity. The Collaborative Perinatal Project reported 595 first-trimester exposures and 2,948 exposures anytime during pregnancy. No relationship was found to large categories of malformations. Possible associations with individual malformation were found. One study reported a statistical relationship between diphenhydramine use in the first trimester and cleft palate. One case of withdrawal in an infant whose mother ingested 150 mg per day of diphenhydramine has been reported. This infant developed tremor on the fifth day of life which was treated with phenobarbital. Ibuprofen has been assigned to pregnancy category B 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. Diphenhydramine-ibuprofen should only be given during pregnancy when benefit outweighs risk. Ibuprofen should be avoided near term (last three months of pregnancy).

One manufacturer of ibuprofen has reported on 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.

Diphenhydramine / ibuprofen Breastfeeding Warnings

Diphenhydramine is excreted into human milk. Diphenhydramine may also inhibit lactation. Ibuprofen has not been detected in human milk. Ibuprofen is considered compatible with breast-feeding by the American Academy of Pediatrics. 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.

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