In most cases of congenital malformations in infants exposed to propoxyphene, other drugs were also used during pregnancy and a clear association between propoxyphene use and the malformations has not been established. Some of the specific malformations described in case reports of infants exposed to propoxyphene (and often other drugs) have included: prune perineum, Pierre Robin syndrome, arthrogryposis, severe caudal dysplasia, micrognathia, microcephaly, ductus arteriosus persistens, cataract, benign tumors, club foot, and limb reduction defects.

The Collaborative Perinatal Project identified 686 mother-child pairs with first trimester exposure to propoxyphene and observed 31 malformed children. (In that group, 34.4 malformed children were expected.)

A study of Michigan Medicaid patients identified 1029 neonates exposed in utero to propoxyphene and observed 41 malformed children (personal communication, Franz Rosa, MD, Food and Drug Administration, 1994). (In that group, 43 malformed children were expected.)

Neonatal propoxyphene withdrawal symptoms include irritability, hypertonicity, jitteriness, increased temperature, tremors, increased appetite, diarrhea and high-pitched cry.

Propoxyphene has not been formally assigned to a pregnancy category by the FDA. Several case reports have described infants exposed to propoxyphene in utero who were born with a variety of congenital malformations. Withdrawal symptoms have also been reported in neonates whose mothers took propoxyphene during pregnancy. There are no controlled data in human pregnancy. Propoxyphene is only recommended for use during pregnancy when benefit outweighs risk.

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Propoxyphene and its active metabolite, norpropoxyphene, are excreted into human breast milk in small amounts. The clinical effects in breast-fed infants have not been described. Propoxyphene is considered compatible with breast-feeding by the American Academy of Pediatrics.

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