Darvon and Darvocet Recall

The popular narcotic pain pills Darvon (propoxyphene) and Darvocet (propoxyphene + acetaminophen) have recently been voluntarily recalled by Xanodyne Pharmaceuticals, Inc. at the request of the FDA.  The medications have been linked to serious and potentially fatal heart rhythm abnormalities.  Darvocet was one of the top 25 most commonly prescribed medications.  Darvocet and Darvon have been prescribed to more than 22 million people.  Doctors have been asked to stop prescribing these drugs, and patients taking the medication are being advised to see their physician immediately to discuss switching to another painkiller.

Background Information on Darvocet and Darvon Recall

In 2009, an outside advisory panel to the FDA recommended that Darvon and Darvocet be pulled from the market after concluding that the pain relief benefits of the drugs did not outweigh the significant risk of side effects related to overdose and addiction.  However, the drugs remained on the market until recent clinical trial data showed that electrocardiogram abnormalities occurred in healthy people taking normal/recommended doses of the drugs.  Electrical activity abnormalities in the heart can lead to a number of heart problems including irregular heartbeats, heart rhythm abnormalities, longer QT intervals and heart arrhythmias. Potentially, these heart problems can cause sudden death, cardiac arrest or the need for a pacemaker.

Darvocet and Darvon – Safety Questioned for Years

The drugs were banned in the UK in 2005, and in Europe almost two years ago.   In fact, in 2005 the British government stated that the efficacy of propoxyphene “…is poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable.” It further said that “It has not been possible to identify any patient group in whom the risk-benefit [ratio] may be positive ... In relation to safety, there is evidence that fatal toxicity may occur with a small multiple of the normal therapeutic dose and a proportion of fatalities are caused by inadvertent overdose. Pharmacokinetic and pharmacodynamic interactions with alcohol further reduce the threshold for fatal toxicity.”

The national, non-profit consumer advocacy group Public Citizen has been unsuccessful since 1978 to get products containing propoxyphene banned in the United States.  In its most recent petition filed with the FDA in February of 2006, Public Citizen urged the drugs to be banned since they had been associated with over 2,000 accidental deaths since the time the UK ban was announced.  In addition, the drugs were physically addictive and were no more effective than other safer painkillers.  The petition was denied by the FDA in July of 2006.

Tampa Darvocet Attorneys

If you or a loved one has taken Darvon or Darvocet and suffered a significant heart rhythm abnormality, please contact the experienced trial lawyers at Alley, Clark & Greiwe for important information about your legal rights.

Consumer Resources on Darvon and Darvocet:

FDA Press Release (11/19/2010)

FDA Panel Urges Ban of Pain Drugs (1/30/09)