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Diflunisal Pregnancy and Breastfeeding Warnings

Diflunisal is also known as: Dolobid

Diflunisal Pregnancy Warnings

A recent review discussed results from a surveillance study of Michigan Medicaid recipients with completed pregnancies. A total of 258 newborns had been exposed to diflunisal during the first trimester of pregnancy. While only 10 major defects were expected, 19 (7.4%) occurred in this population. One cardiovascular defect (3 expected), one oral cleft (0.4 expected), one case of polydactyly (one expected), and one case of hypospadias (one expected) were noted. Descriptions of the remaining defects were not noted. The contribution of diflunisal to the increased incidence in birth defects in this population remains to be seen.

Diflunisal has been assigned to pregnancy category C by the FDA. Some animal studies have revealed evidence of embryotoxicity and teratogenicity. There are no controlled data in human pregnancy. In one surveillance study, nineteen major birth defects were noted in 258 pregnancies with diflunisal use in the first trimester. In addition, use late in pregnancy may cause premature closure of the ductus arteriosus and prolong labor and delivery. Diflunisal should only be given during pregnancy when benefit outweighs risk. Diflunisal should be avoided near term.

Diflunisal Breastfeeding Warnings

Diflunisal is excreted into human milk in small amounts. Milk concentrations range from 2% to 7% of corresponding maternal serum concentrations. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue diflunisal, taking into account the importance of the drug to the mother.

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