FDA bans Darvon, Darvocet amid long-standing concerns

Although the FDA has taken the step of banning painkillers Darvon and Darvocet amid decades of safety concern, officials advise against sudden discontinuation of the meds due to a strong possibility of withdrawal symptoms.

Concerns stem from propoxyphene, associated with heart-related side effects even in young and healthy patients. The medications have been banned for six years in the UK and more than a year in by Europe’s equivalent of the FDA, and a researcher with the FDA commented:

“The drug puts patients at risk of abnormal or even fatal heart rhythm abnormalities,” John Jenkins, MD, director of the FDA’s office of new drugs at the Center for Drug Evaluation and Research, said at a news conference. “Combined with prior safety data, this altered our risk assessment.”

One bright spot is that the FDA concedes that long term users need not worry about lingering effects of using the medications:

Dal Pan says that people who have taken Darvocet, Darvon, or other propoxyphene drugs for a long time are not at increased risk of heart problems.

[WebMD, Image]

“Long-term users should not worry: The heart effects are not cumulative,” [Dr. Gerald Del Pan] says. “Once people stop using propoxyphene, the side effects should go away.”

A group that has been lobbying for a ban of medications containing propoxyphene since 1978 has accused the FDA of dragging their feet on the ban, and say between 1,000-2000 Americans have died from the side effects since the UK ban has been in place.