FDA yanks controversial painkiller Darvon

After years of debate over their safety, FDA has moved to withdraw painkillers Darvon and Darvocet, plus the multitude of generic copycats. Why now? The agency says it received new data showing that propoxyphene, an active ingredient in both drugs, increases the risk of serious--even fatal--abnormal heart rhythms.

"These new heart data significantly alter propoxyphene's risk-benefit profile," the FDA's John Jenkins says in a statement. "The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks." 

Some would argue that the risk-benefit profile has been stacked too heavily on the risk side for years. Potentially addictive, the drug is also difficult to dose, because there's a fine line between an effective dose and a toxic one, the New York Times notes. The consumer watchdog Public Citizen started agitating for Darvon's demise back in 1978. Then, in 2005, the U.K. yanked propoxyphene drugs on worries about overdosing. Public Citizen followed up with another petition for withdrawal in 2006.

Last year, European regulators advised withdrawal; soon after, an FDA advisory panel recommended that the agency pull the drugs off the market, but the agency decided to put a boxed warning on them instead. At the time, FDA asked Darvon's maker, Xanodyne, to conduct a new study--and that's the study that unveiled the heart-rhythm troubles. The agency now is asking physicians to stop prescribing the drugs and recommends patients contact their doctors about alternatives.

- get the statement from FDA
- see the Wall Street Journal Health Blog story
- check out the NYT article

On-Demand Webinar

Leveraging A Medical Record-Enriched Patient Dataset for COVID-19 Research

You are invited to join a webinar that will explore the ways researchers can leverage this enriched dataset for important COVID-19 research. Sign up today for this informative webinar to learn how you can leverage one of the only medical record reviews solely using real-world data from hospitalized COVID-19 patients.

Suggested Articles

Life sciences companies have pivoted quickly during COVID-19 - Syneos Health® is supporting more than 80 active COVID-19 projects, including vaccines.

New York's Covaxx has signed on with three South American nations to provide 140 million doses of its early-stage COVID-19 vaccine.

To get the COVID-19 vaccine out quickly, Pfizer has been running rehearsals at distribution sites, creating "growing confidence," U.S. officials said.