The pain killer propoxyphene, sold under brand names Darvon and Darvocet, was pulled from the market after a new clinical study proved that the drug, even when taken at recommended doses, puts patients at risk of potentially serious or fatal heart rhythm abnormalities, which can cause harmful adverse effects, including sudden death.

Darvon, first approved by FDA in the 1950s, is a propoxyphene–containing pain killer used to treat mild to moderate pain. Subsequently, the developer of propoxyphene, Eli Lilli & Co., combined Darvon with another active ingredient, called acetaminophen, and sold it under the brand name Darvocet.

The medical community has expressed serious concerns over the drug in the last 50 years, and the consumer group Public Citizen petitioned the FDA in 1978 and 2006 to ban the drug from the market due to its dangerous toxicity and the risk of causing abnormal heart rhythms. The U.K. and then the entire European Union have banned the drug in 2005 and 2009, respectively. Finally, on November 19, 2010, Xanodyne Pharmaceuticals, the maker of Darvon and Darvocet, agreed to withdraw the drugs from the market after a request from the FDA. The FDA announced that the risks of taking propoxyphene outweigh its benefits and encouraged all generic manufacturers to follow suit and pull theirs drugs from the market.

Propoxyphene affects the heart rhythm, which leads to heart malfunction, arrhythmia, and ventricular or atrial fibrillation. Cardiac arrhythmia symptoms include heart palpitations, which may be frequent, infrequent, or continuous. Arrhythmias can lead to increased chance of blood clots, strokes and heart attacks. Even a temporary heart malfunction could cause a lack of blood to the brain or other organs, which can result in serious and permanent damage to your health.

Elderly people, patients with reduced kidney function and patients with pre–existing arrhythmias may be at increased risk of cardiotoxicity and sudden death.

If you have taken propoxyphene and are experiencing any symptoms associated with cardiac arrhythmias, it is vital to seek immediate medical attention. Please be aware that the risks of propoxyphene are far more serious than indicated on the drug labels.

If you or your loved one have taken Darvon, Darvocet or other propoxyphene–containing drugs and suffered side effects, please contact the lawyers of The Ferraro Law Firm at 1–800–275–3332 or via email for a Free Case Evaluation.

Our offices are conveniently located for clients in Miami, Florida,Washington DC and New York City, NY. We also serve clients nationwide and regularly travel to our clients’ homes and offices.

Important Links:

FDA Announcement – Propoxyphene: Withdrawal – Risks of Cardiac Toxicity

FDA Drug Safety Communication: FDA Recommends Against the Continued Use of Propoxyphene

FDA News Release: Xanodyne Agrees to Withdraw Propoxyphene from the U.S. Market

Bloomberg Article: Darvon, Darvocet Withdrawn in U.S. Over Heart Risks

Public Citizen: Delayed FDA Removal of Painkiller Propoxyphene (Darvon, Darvocet) From U.S. Market Has Cost More Than 1,000 U.S. Lives