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Approved by the FDA in 1957, Darvon (propoxyphene) was once one of the most popular drugs in the U.S. for mild to moderate pain. In fact, as of 2007, an estimated 20 million prescriptions were filled.

Studies performed over the years, however, found that Darvon and Darvocet (Darvon combined with acetaminophen) are associated with potentially-fatal heart abnormalities. As a result, Xanodyne Pharmaceuticals took both medications off the market in 2010, after the FDA stated Darvon and Darvocet increase patients’ risk of abnormal heart rhythm.

Studies and Cardiovascular Warnings

The push to remove Darvon and Darvocet began in January 2009, when Public Citizen’s Health Research Group claimed both prescriptions are linked to 523 deaths, as well as an additional 2,000 accidental fatalities since 1981.

Researchers discovered the correlation in the 1970s, when prescription reached its highest point, but the FDA began an investigation in 2006, after a petition from the Public Citizen’s Health Research Group. The organization, however, filed a lawsuit two years later, claiming the FDA failed to act.

That year, the FDA recommended a recall, but a black box warning had been added instead.

By 2010, Xanodyne withdrew Darvon, Darvocet, and their generic equivalents, and the FDA advised healthcare professionals to stop prescribing it, recommending instead that doctors discuss new pain management strategies with patients.

Over the years, multiple studies pointed to adverse cardiovascular risks from taking Darvon and Darvocet. One found recommended doses affect the heart’s electrical activity, resulting in abnormal heart rhythm and death.

Other Side Effects and Warnings

Several other side effects have been associated with taking Darvon and Darvocet:

  • Allergic reactions
  • Breathing difficulties
  • Confusion
  • Fainting spells
  • Hallucinations
  • Severe stomach pains
  • Yellowing of skin or whites of eyes
  • Dizziness
  • Drowsiness
  • Headache
  • Nausea
  • Vomiting

In addition to such potential reactions, the FDA previously issued a warning that patients with a risk of suicidal thoughts or actions should not take either medication in conjunction with sedatives or antidepressants, particularly if large amounts of alcohol were consumed.

Lawsuits

Wrongful death and personal injury lawsuits continue to be filed at the state level, although, as of 2010, certain cases have been consolidated into multi-district litigation in the U.S. District Court, Eastern District of Kentucky.