Washington, DCThe US Food and Drug Administration (FDA) announced late last week that it requested the removal of two pain medications from the market due to the potential for negative impact on heart rhythms. CNN reported Friday that the manufacturers of Darvon and Darvocet agreed to remove the two prescription meds from the market, at the urging of the FDA.
The FDA also urged the makers of generic versions of the two drugs to pull them from the market as well.
"We recommend to physicians stop prescribing the drugs," said Gerald Dal Pan, director of the FDA's Office of Surveillance and Epidemiology. "As for patients, do not stop taking it, but we urge you to contact your health care professional. Do not delay."
Propoxyphene (Darvon) has been on the market for more than 50 years. First approved by the FDA in 1957, the opioid drug used to treat mild to moderate pain has been the subject of controversy in the past. CNN reports that since 1978, the FDA has received two requests to remove the pain medication from the market. However, in both cases the FDA determined the benefits outweighed the risks.
That all changed this year, after the FDA reviewed the results of a clinical study that raised increasing concern over heart risks.
Propoxyphene is sold as Darvocet when combined with acetaminophen.
Xanodyne Pharmaceuticals Inc. is the manufacturer of the Darvon and Darvocet brands—two drugs that have been prescribed (including generics) to 10 million people since 2009.
"The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks," the FDA said in a statement released Friday.