FDA Pulls Darvon, Darvocet from Market for Heart Risks

The maker of the pain killer medicine known as Darvon and Darvocet, or propoxyphene, announced last week it will stop making the popular drugs because it can cause serious heart rhythm abnormalities, according to a new study.

Xanodyne Pharmaceuticals Inc. agreed to the ban Darvocet, Darvon and its generic versions at the request of the Food & Drug Administration. The new ban brings the drug in line with European regulatory agencies that banned the drug more than a year ago.

The new study indicates that even when Darvon or Darvocet is taken at the recommended dosages, “there were significant changes to the electrical activity of the heart.” The new findings outweigh the potential benefit, the FDA said in a statement.

While it’s good the FDA is finally pulling Darvon and Darvocet from the market, it’s disconcerting that it’s taken this long for it to do so. In 2009, an FDA committee voted 14-12 against the continued making of propoxyphene products but noted additional information would be helpful. The FDA required the drug maker to conduct the study, and its results confirm concerns the medical community has raised about the drug since it was first approved by the FDA in 1957.

“We recommend to physicians stop prescribing the drugs. As for patients, do not stop taking it, but we urge you to contact your health care professional. Do not delay,” Gerald Dal Pan, director of the FDA’s Office of Surveillance and Epidemiology, told CNN last week.

Since 2009, more than 10 million patients have been prescribed some form of propoxyphene, according to the FDA. The Simmons law firm is currently investigating claims on behalf of those patients injured due to taking Darvon, Darvocet or the generic versions of propoxyphene.

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