History of Darvon / Darvocet Recall

On January 30, 2009, a meeting of the FDA Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee was convened to review the efficacy and safety of propoxyphene-containing products. The FDA determined that the benefits of these drugs no longer outweighed the cardiac conduction risks. On November 19, 2010, the drug manufacturer, Xanodyne Pharmaceuticals, voluntarily withdrew Darvon and Darvocet from the U.S. markets.

Drug safety advocates have long pushed for the recall of Darvon, Darvocet, and other propoxyphene-based medications. Some say that the Darvon/Darvocet recall should have come far sooner considering the drugs were banned by the European Drug Agency 18 months ago and banned in the UK six years ago.

Reasons for the Darvocet / Darvon Recall

The active ingredient in Darvon and Darvocet, propoxyphene, has come under fire for several reasons. In the past, safety advocates noted the risk for addiction, suicide and accidental overdose. More recently, the risk of fatal and abnormal heart rhythms was revealed.

According to the FDA, “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 ECG, can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death.”

Side Effects of Propoxyphene Drugs – Darvon and Darvocet

If you are taking or have taken Darvon or Darvocet, possible side effects include:

• Drowsiness
• Dizziness
• Cardiac arrest/arrhythmia
• Nausea/vomiting
• Hallucinations
• Liver problems
• Accidental overdose
• Suicide

What to Do With A Darvon / Darvocet Prescription

The FDA has advised anyone who is currently taking Darvon, Darvocet, or their generic counterparts to consult with their physician to discuss alternative pain management medications. Withdrawal symptoms may occur and should be monitored closely by your doctor.

If you are experiencing any of the serious side effects associated with this class of drugs, consider speaking with an experienced Darvon recall attorney. You may be eligible for compensation, but only a qualified drug recall attorney can evaluate your case and accurately determine what you are entitled to receive.