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Pregnancy Class Darvocet

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® (propoxyphene/acetaminophen) is a prescription pain reliever that may not be safe for pregnant women.
Most medications are assigned to a pregnancy class. 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).
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.
(Click Darvocet and Pregnancy for more information about which pregnancy class Darvocet belongs to and to learn more about the potential dangers of using this medication while pregnant.)
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