Darvon (known generically as propoxyphene) and Darvocet (a combination of acetaminohen and propoxyphene) are narcotic analgesics. They are prescribed to reduce pain but were removed from the market in November 2010. The recall came after the US Food and Drug Administration (FDA) announced that propoxyphene increases the risk of serious or fatal heart rhythm abnormalities.
According to an FDA spokesperson, propoxyphene was withdrawn from the market because data indicated that the drug was linked to "serious toxicity to the heart, even when used at therapeutic doses." A study done on propoxyphene found that patients who took it at the recommended therapeutic doses had an increased risk of changes to the heart's electrical activity. The study was even put on clinical hold because of safety concerns.
Furthermore, the FDA expressed concern that elderly patients and patients with renal insufficiency were at risk because the medication would be cleared more slowly from their bodies.
"FDA has concluded that the safety risks of propoxyphene outweigh its benefits for pain relief at recommended doses," the agency said.
The FDA's announcement regarding propoxyphene came too late for some people. Back in 2009, a Citizen Petition was sent to the agency, requesting the removal of propoxyphene from the market.
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Lawsuits have also been filed by patients who say their health was affected by taking the medication. Whether or not the lawsuits will be consolidated before one judge remains to be seen. A decision is expected at any time.
The propoxyphene recall affected both brand name and generic products containing the drug.
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Michael L. Rogers
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