On November 19, 2010 Xanodyne Pharmaceuticals Inc. which manufacturers Darvon and Darvocet, the brand name version of the prescription pain medication propoxyphene, has agreed to withdraw the medicine from the US market at the request of the US Food and Drug Administration. The Food and Drug Administration has also informed the generic makers of propoxyphene-containing drugs of Xanodyne’s decision and requested that they voluntarily recall their drugs as well.
The FDA sought market removal of propoxyphene after receiving new clinical data showing that the medicine puts individuals at risk of possibly extreme or even fatal heart rhythm abnormalities. As a result of these info, combined with other information, which include new epidemiological data, the agency concluded that the risks of the drug outweigh the benefits.
“The Food and Drug Administration is pleased by Xanodyne’s choice to voluntarily recall its drugs from the US market,” said John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER). “These new heart data significantly alter propoxyphene’s risk-benefit profile. The drug’s effectiveness in reducing pain is no longer enough to outweigh the drug’s serious potential heart risks.”
The FDA is notifying health care professionals to discontinue prescribing propoxyphene to their patients, and patients who are currently using the medication really should get in touch with their health care professional as soon as possible to talk about switching to a different pain management treatment.
What is the problem with Darvocet?
Darvocet, also known as Propoxyphene Acetaminophin, is used to treat mild to moderate pain. It is also used for pain before, during, and after surgery. It was the 12th most prescribed drug in 2004 with almost 23 million prescriptions written. In February 2006, the Public Citizen urged the FDA to ban both Darvocet and Darvon, another popular pain killer in the same class made up Propoxyphene alone. Over 10,000 deaths, at least 2,110 of those being accidental overdoses, have been reported after the use of Darvocet and Darvon.
Side Effects of Darvocet
There are a variety of side effects associated with Darvocet. Our firm is pursing the following types of serious, life-threatening side effects:
- Accidental Overdose
- Cardiac Emergency