November 19, 2010: RECALL
Xanodyne Pharmaceuticals Inc., which makes the pain medications Darvon and Darvocet, has agreed to voluntarily withdraw each medication from the U.S. market at the request of the Food and Drug Administration (FDA).
According to the FDA, the withdrawal of the pain medication propoxyphene was decided after new data was released showing that the drug puts patients at risk of “potentially serious or even fatal heart rhythm abnormalities.” In combination with other data, it was decided that the risks of the medication outweigh the benefits.
Propoxyphene is an opioid used to treat mild to moderate pain, which is the main active drug in Darvon, which is also sold as Darvocet (with acetaminophen added). Propoxyphene can cause significant changes to the electrical activity of the heart. These changes can increase the risk of abnormal heart rhythms and sudden death.
Darvon and Darvocet Lawsuits: Patients who have suffered serious side effects following the use of Darvon, Darvocet, or generic propoxyphene may be eligible to receive monetary compensation.
Serious Side Effects Include:
- Heart Attack
- Abnormal Heart Rhythms (Heart Arrhythmia)
- Sudden Death
Since 1978, the FDA has received 2 requests to remove propoxyphene from the market.
January 2009: the FDA held an advisory committee meeting to discuss the safety of the drug. After the review of data there was a 14 to 12 vote against the continued marketing of propoxyphene.
June 2009: The European Agency (EMEA) announced that the marketing of propoxyphene be withdrawn across the European Union. A phased withdrawal is currently in effect.
July 2009: FDA permitted the continued marketing of the drug, but required a new warning label that warned against the risk of fatal overdose. A new safety study was also required of Xanodyne Pharmaceuticals Inc.