FDA Recalls Darvon, Darvocet, Propoxyphene Medication Due to Heart Issues

Darvon and Darvocet, are medications which have been prescribed to relieve mild to moderate pain for many years.  Proproxyphene is the active ingredient in these medications.  It is also the generic form of these medications.  There has been concern over the safety of these drugs for quite some time.

The FDA had received requests to have these medications removed from U.S. markets in 1978 and again in 2006 due to ongoing concerns regarding their safety.   In 2009 an advisory committee met with the FDA and discussed these safety concerns.  On January 30, 2009 that advisory committee voted 14 – 12 to remove all drugs containing propoxyphene from the market.  In response to the 2009 request for removal, the FDA asked that a new study be done to address the issues raised by the advisory committee.

Recently the FDA received the results of that study.  Accordingly, on November 19, 2010, the FDA finally asked for recall of all medications, such as Darvon and Darvocet, which contain Proproxyphene.  The FDA states in its press release:

The agency now has reviewed the data from that study, which show that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart.  These changes, which can been seen on electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death.  The available data also indicates that the risk of adverse events for any particular patient (even patients who  have taken the drug for many years) is subject to change based on small changes in the heath status of the patient, such as dehydration, a change in medications, or decreased kidney function.

The FDA is not the first to call for the withdrawal of propoxyphene containing medications from the market.  In 2005 these drugs were withdrawn from the market in Great Britain due to that country’s concern over safety issues.   In 2009 the drug started to be withdrawn from European markets at the recommendations of the European Medicines Agency. 

Darvon, Darvocet and Propoxyphene have been widely prescribed in the United States.   It is estimated that approximately 10 million prescriptions were written for them in 2009.  If you believe you or someone you care about has suffered as a result of taking a propoxyphene medication or you have any questions feel free to contact us.