FDA pulls Darvon, Darvocet from market
Monday, November 22nd, 2010The popular painkillers Darvon and Darvocet (propoxyphene) have been pulled from the market because of their association with serious or even fatal heart rhythm abnormalities.
The US Food & Drug Administration (FDA) is also asking the manufacturers of generic propoxyphene-containing products to remove those products from the market.
Darvon and Darvocet are both made by Xanodyne Pharmaceuticals Inc. Propoxyphene is an opium-derivative used to treat mild to moderate pain. First approved by the FDA in 1957, propoxophene is sold by prescription under various names both alone (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet).
The US Food and Drug Administration has since reviewed the data from a recent study, which show that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death, the FDA said.
The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function, the agency said. As a result of these data, combined with other information, including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits.