Darvocet and Pregnancy

It may not be safe for pregnant women to take Darvocet (propoxyphene/acetaminophen), as it could result in birth defects. Cataracts, clubfoot, and other problems have been reported in babies born to mothers who took the drug. However, it is impossible to tell for sure if these problems were actually caused by the medication itself or other factors. If you are taking this medication and pregnancy occurs, notify your healthcare provider immediately.

Is Darvocet Safe During Pregnancy?

Darvocet® (propoxyphene/acetaminophen) is a prescription pain medication. Based on reports of rare problems in humans, the drug may not be safe for use during pregnancy.
 

Darvocet and Pregnancy Category C or D

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Darvocet does not actually have an FDA-assigned pregnancy rating, as it was approved prior to the current pregnancy rating system. However, other trustworthy sources have assigned Darvocet a Category C rating (for short-term use) or a Category D rating (for prolonged use).
 
Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but that do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating. Pregnancy Category D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women but may still offer benefits that outweigh the risks the drug presents.
 
Various birth defects have been reported possibly due to Darvocet, but it is impossible to tell for sure if these problems were actually caused by Darvocet, other medications that were taken, or simply coincidence. One study suggests a possible link between Darvocet and the following birth defects:
 
  • Microcephaly (abnormally small head)
  • Cataracts
  • Non-cancerous tumors
  • Clubfoot
  • Patent ductus arteriosus (a heart defect).
     
Other studies are necessary to confirm these findings before it can be said with certainty that Darvocet actually causes these problems. As is usually the case, it is assumed that the risk for birth defects due to Darvocet is greatest when the medication is taken early in pregnancy.
 
Additionally, chronic use of this drug during pregnancy can result in Darvocet withdrawal in the newborn, including symptoms such as:
 
  • Irritability
  • Shakiness (tremors)
  • Diarrhea
  • Fever
  • High-pitched cry
  • Sweating
  • Seizures
  • Muscle tension.
     
(Darvocet and Pregnancy Continued: Page 2)
Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;
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