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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.
In November 2010, the United States Food and Drug Administration (FDA) withdrew all medications that contain propoxyphene from the market. It has been determined that the risks of propoxyphene outweigh the possible benefits. In particular, the FDA was concerned about the drug's ability to cause serious changes in the heart rhythm, even at normal doses. Pharmacies will no longer sell this medication, and people who take it should stop and ask their healthcare provider for a more suitable pain medication.

Darvocet and Pregnancy Category C

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. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but do appear to cause harm to the fetus in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
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.
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