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Darvon and Pregnancy

In studies on the active ingredient in Darvon (propoxyphene hydrochloride) and pregnancy, certain birth defects were reported. One study showed that this medicine may cause microcephaly, noncancerous tumors, and clubfoot. If you become pregnant while taking this drug, your healthcare provider will weigh the benefits and potential risks before making a recommendation.

Can Pregnant Women Take Darvon?

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

What Is Pregnancy Category C?

The U.S. Food and Drug Administration (FDA) uses a pregnancy 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. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
There have been reports of birth defects possibly caused by propoxyphene (the active ingredient in Darvon), but it is impossible to know for sure if these problems were actually caused by Darvon, other medications that were taken, or simply coincidence. One study suggests a possible link between propoxyphene and the following birth defects:
  • Microcephaly (abnormally small head)
  • Cataracts
  • Noncancerous tumors
  • Clubfoot
  • Patent ductus arteriosus (a heart defect).
Other studies are necessary to confirm these findings before it can be said with certainty that Darvon actually causes these problems. As is usually the case, it is assumed that the risk for birth defects due to Darvon is greatest when the medication is taken early in pregnancy.
Additionally, chronic use of this pain medicine during pregnancy can result in Darvon withdrawal in the newborn, including symptoms such as:
  • Irritability
  • Shakiness (tremors)
  • Diarrhea
  • Fever
  • High-pitched cry
  • Sweating
  • Seizures
  • Muscle tension.
8 Frequent Pain Syndromes

Darvon Medication Information

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