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Propoxyphene Pregnancy and Breastfeeding Warnings

Brand names: Darvon, Darvon-N, PP-Cap

Propoxyphene Pregnancy Warnings

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.

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.

See references

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.

See references

See also

References for pregnancy information

  1. Heinonen O, Shapiro S; Kaufman DW ed., Slone D (1977) "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc., p. 297
  2. Strode SW (1985) "Propoxyphene dependence and withdrawal." Am Fam Physician, 32, p. 105-8
  3. Ringrose CA (1972) "The hazard of neurotropic drugs in the fertile years." Can Med Assoc J, 106, p. 1058
  4. Golden NL, King KC, Sokol RJ (1982) "Propoxyphene and acetaminophen. Possible effects on the fetus." Clin Pediatr (Phila), 21, p. 752-4
  5. Tyson HK (1974) "Neonatal withdrawal symptoms associated with maternal use of propoxyphene hydrochloride (Darvon)." J Pediatr, 85, p. 684-5
  6. Quillian 2d, Dunn CA (1976) "Neonatal drug withdrawal from propoxyphene." JAMA, 235, p. 2128
  7. Barrow MV, Souder DE (1971) "Propoxyphene and congenital malformations." JAMA, 217, p. 1551-2
  8. Klein RB, Blatman S, Little GA (1975) "Probable neonatal propoxyphene withdrawal: a case report." Pediatrics, 55, p. 882-4
  9. Poskitt EM, Hensey OJ, Smith CS (1982) "Alcohol, other drugs and the fetus." Dev Med Child Neurol, 24, p. 596-602
  10. Ente G, Mehra MC (1978) "Neonatal withdrawal from propoxyphene hydrochloride." N Y State J Med, 78, p. 2084-5
  11. Williams DA, Weiss T, Wade E, Dignan P (1983) "Prune perineum syndrome: report of a second case." Teratology, 28, p. 145-8
  12. (2001) "Product Information. Darvon (propoxyphene)." Lilly, Eli and Company
  13. Koren G, Pastuszak A, Ito S (1998) "Drugs in pregnancy." N Engl J Med, 338, p. 1128-37

References for breastfeeding information

  1. Kunka RL, Venkataramanan R, Stern RM, Ladik CF (1984) "Excretion of propoxyphene and norpropoxyphene in breast milk." Clin Pharmacol Ther, 35, p. 675-80
  2. Committee on Drugs, 1992 to 1993 (1994) "The transfer of drugs and other chemicals into human milk." Pediatrics, 93, p. 137-50
  3. Kunka RL, Yong CL, Ladik CF, Bates TR (1985) "Liquid chromatographic determination of propoxyphene and norpropoxyphene in plasma and breast milk." J Pharm Sci, 74, p. 103-4

Further information

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