Heart Risks Cited in FDA Ban on Darvon and Darvocet

Pharmacists can expect questions about the FDA’s withdrawal of 2 opioid painkillers.

A recent FDA action will stir questions from patients taking Darvon or Darvocet, 2 opioid painkillers manufactured by Xanodyne Pharmaceuticals Inc.

The agency asked the drug maker to withdraw the controversial pain drugs from the US market, citing safety concerns about the active ingredient propoxyphene. The request followed the release of clinical trial results that showed propoxyphene’s potential to cause serious and even fatal heart rhythm abnormalities, or arrhythmias.

John Jenkins, MD, director of the FDA’s Office of New Drugs at the Center for Drug Evaluation and Research, said the trial confirmed that “the pain benefits of propoxyphene no longer outweighed the heart risk and that propoxyphene should no longer be sold in the United States.” A similar recommendation was made last year by the European Medicines Agency, prompting a phased withdrawal of the drug from the European market.

The FDA is currently working with physicians to stop the prescription of propoxyphene-containing medications. In the meantime, pharmacists should counsel patients who are currently taking the drugs to speak with a physician to discuss appropriate alternatives. They should not discontinue the drugs immediately, however.

“You still need to manage your pain,” said Gerald Dal Pan, MD, director of the FDA’s Office of Surveillance and Epidemiology. “Instead, we urge you to contact your health care professional as soon as possible to discuss switching to another pain-management therapy.”

Dr. Dal Pan also said symptoms such as heart palpitations, dizziness, and light-headedness are warning signs of adverse effects, and that patients who experience them should contact their physician immediately. For more information, patients can call Xanodyne’s medical information hotline at 877-773-7793.