FDA Pulls Painkillers Darvon & Darvocet Over Heart Risks
After decades of debate over the safety of popular painkillers Darvon and Darvocet, the drugs will be removed from the market because they are linked to potentially fatal heart risks in healthy people who take the medicines at the recommended dose.
The owner of the Darvon and Darvocet, Xanodyne Pharmaceutical Inc., agreed to pull the drugs at the request of the U.S. Food and Drug Administration. The agency also ordered generic drug makers to stop making and selling low-cost drugs containing the drugs’ active ingredient, propoxyphene.
The risks are widespread and affect millions of people nationwide. In 2009 alone, doctors prescribed Darvon or Darvocet to an estimated 10 million patients.
Studies show that the drugs interfere with the electrical activity of the heart, causing irregular and potentially deadly heart rhythms in otherwise healthy patients. Intentional or unintentional overdoses can also occur when the drugs are taken alone, with alcohol, or with other medications.
Doctors are urged to immediately stop prescribing the drugs and the FDA recommends that patients quickly consult with their doctors to arrange alternative medications.
Critics say the decision is a long time coming. Britain banned the drugs in 2005, citing reports of as many as 400 fatal overdoses a year. The European Union followed in 2009