On November 19, 2010 Xanodyne Pharmaceuticals Inc. which markets Darvon and Darvocet, the brand version of the prescription pain medicine propoxyphene, has agreed to remove the medication from the United States market at the request of the United States Food and Drug Administration. The FDA has also told the generic makers of propoxyphene-containing products of Xanodyne's decision and requested that they voluntarily remove their products as well.

The Food and Drug Administration sought market removal of propoxyphene immediately after getting new clinical info showing that the drug puts individuals at risk of possibly extreme or even fatal cardiovascular rhythm abnormalities. As a result of these info, combined with other information, for example new epidemiological data, the agency concluded that the dangers of the medicine outweigh the advantages.

"The FDA is pleased by Xanodyne's decision to voluntarily withdraw its products from the United States 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 telling health care professionals to discontinue prescribing propoxyphene to their patients, and patients who are already taking the medicine ought to make contact with their health care professional as soon as possible to talk about switching to another pain management remedy.

What is propoxyphene?

Propoxyphene is an opioid pain reliever used to treat light to moderate pain. It is sold under numerous names as a single-ingredient product (e.g., Darvon) and as part of a mixture product with acetaminophen (e.g., Darvocet). Propoxyphene can be marketed under such names as Dolene, Propacet 100, Wygesic, SK-65, SK-65 APAP, Trycet, Genagesic, E-Lor, and Balacet.

Why has FDA requested manufacturers of propoxyphene to withdraw propoxyphene containing prescription medicines off the market?

Records from a new study have become available that shows that propoxyphene causes considerable changes to the electrical activity of the heart, even when the medication is used at therapeutic doses. These modifications, prolonged PR interval, widened QRS complex and prolonged QT interval, which can be seen on an electrocardiogram (ECG), can increase the danger for severe abnormal heart rhythms.

A patient's risk for these cardiac effects while using propoxyphene can change at any time, even when the patient has been taking propoxyphene for quite a few years. A change in the patient's disease state, intake of other drug treatments, or a decrease in kidney function can significantly increase their risk for cardiac effects with propoxyphene.

In accordance with this new info, Food and Drug Administration believes this action is critical to ensure patient safety.

If you or possibly a loved one has been injured or killed by either Darvocet, Davron, or some other medicine containing propoxyphene, you ought to call our lawyers immediately. It's possible you'll be entitled to payment by filing a class action and we will help.