Propoxyphene Pregnancy and Breastfeeding Warnings
Propoxyphene Pregnancy Warnings
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.
Propoxyphene Breastfeeding Warnings
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.
References for pregnancy information
- Quillian 2d, Dunn CA "Neonatal drug withdrawal from propoxyphene." JAMA 235 (1976): 2128
- Barrow MV, Souder DE "Propoxyphene and congenital malformations." JAMA 217 (1971): 1551-2
- Ente G, Mehra MC "Neonatal withdrawal from propoxyphene hydrochloride." N Y State J Med 78 (1978): 2084-5
- Tyson HK "Neonatal withdrawal symptoms associated with maternal use of propoxyphene hydrochloride (Darvon)." J Pediatr 85 (1974): 684-5
- Williams DA, Weiss T, Wade E, Dignan P "Prune perineum syndrome: report of a second case." Teratology 28 (1983): 145-8
- "Product Information. Darvon (propoxyphene)." Lilly, Eli and Company, Indianapolis, IN.
- Klein RB, Blatman S, Little GA "Probable neonatal propoxyphene withdrawal: a case report." Pediatrics 55 (1975): 882-4
- Koren G, Pastuszak A, Ito S "Drugs in pregnancy." N Engl J Med 338 (1998): 1128-37
- Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
- Poskitt EM, Hensey OJ, Smith CS "Alcohol, other drugs and the fetus." Dev Med Child Neurol 24 (1982): 596-602
- Golden NL, King KC, Sokol RJ "Propoxyphene and acetaminophen. Possible effects on the fetus." Clin Pediatr (Phila) 21 (1982): 752-4
- Strode SW "Propoxyphene dependence and withdrawal." Am Fam Physician 32 (1985): 105-8
- Ringrose CA "The hazard of neurotropic drugs in the fertile years." Can Med Assoc J 106 (1972): 1058
References for breastfeeding information
- Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
- Kunka RL, Venkataramanan R, Stern RM, Ladik CF "Excretion of propoxyphene and norpropoxyphene in breast milk." Clin Pharmacol Ther 35 (1984): 675-80
- Kunka RL, Yong CL, Ladik CF, Bates TR "Liquid chromatographic determination of propoxyphene and norpropoxyphene in plasma and breast milk." J Pharm Sci 74 (1985): 103-4
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