Darvon-N and Pregnancy

The active ingredient in Darvon-N (propoxyphene napsylate) may cause birth defects, such as clubfoot, noncancerous tumors, or a heart defect. However, it is not known with certainty if these problems were caused by the medicine or other factors. Due to potential risks, the FDA considers Darvon-N a pregnancy Category C medication, which means it may not be safe for women who are expecting.

Can Pregnant Women Take Darvon-N?

Darvon-N® (propoxyphene napsylate) is a prescription pain medication. It is not yet clear if this medication is safe for use during pregnancy.

What Is 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 that were possibly due to propoxyphene (the active ingredient in Darvon-N), but it is impossible to tell for sure if these problems were actually caused by Darvon-N, other medications that were taken, or simply coincidence.
One study suggests a possible link between propoxyphene and the following birth defects or problems:
  • Noncancerous tumors
  • Clubfoot
  • Microcephaly (abnormally small head)
  • Cataracts
  • Patent ductus arteriosus (a heart defect).
Other studies are necessary to confirm these findings before it can be said with certainty that Darvon-N actually causes these problems. As is usually the case, the risk for birth defects due to Darvon-N use is likely greatest when the medication is taken early in pregnancy.
In addition, chronic use of Darvon-N during pregnancy can result in withdrawal symptoms in the newborn, such as:
  • Fever
  • High-pitched cry
  • Sweating
  • Irritability
  • Shakiness (tremors)
  • Diarrhea
  • Seizures
  • Muscle tension.
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Darvon-N Medication Information

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