Serious Side Effects of Darvon® & Darvocet®
FDA Advisory Committee Recommends Ban on Darvon®
February 12, 2009 — In a 14 to 12 vote, an advisory committee to the Food and Drug Administration (FDA) recommended that Darvon® be banned from use as a pain relief medication in the U.S. The recommendation came out of a joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee held on January 30, 2009 to discuss the risks of propoxyphene–containing products. Darvon®, a prescription pain medication manufactured by Eli Lilly, contains propoxyphene as does Darvocet®, a combination of propoxyphene and acetaminophen.
Although the FDA often acts on the recommendations of its advisory committees, it is not required to do so. Rather than removing the drug from the market, the FDA’s other options include issuing warnings, initiating safety studies, or to direct special education efforts at physicians and patients.
History of Controversy Over Banning Darvon®
Darvon® has been the object of controversy for at least 30 years. Public Citizen, a nonprofit public interest organization, first petitioned the FDA to remove Darvon® from the market in 1978 based on the pain medication’s relatively weak pain relief compared to the drugs’ adverse side effects. After Darvon® was banned in the UK in 2005, Public Citizen again petitioned the FDA in 2006 to ban the drug. Finally, Public Citizen sued the FDA in 2008 when the agency failed to respond to the previous petitions.
Adverse Health Effects of Darvon®
The drug was first approved in 1957 when very few alternatives for pain sufferers existed. Today, it is among the top 25 most commonly prescribed drugs for pain. In 2007 alone, 20 million prescriptions were written. Currently Darvon® is not only under scrutiny for its addictive properties and incidence of suicide in those who take it, but also for its role in deaths through accidental overdose and other health risks related to the heart and liver.
Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, presented new data to the joint advisory committees on the safety of Darvon® as a pain treatment. Quoting figures from the Drug Abuse Warning Network (DAWN), Dr. Wolfe pointed out in his statement that those deaths attributable to Darvon® increased from 446 in 2006 to 503 in 2007, 20 percent of which were classified as intentional suicides.
When the body metabolizes Darvon® (propoxyphene), it creates a toxic cardiac metabolite, norpropoxyphene. Both propoxyphene and norpropoxyphene are accumulated in the liver and heart. In the liver, it may inhibit the liver’s ability to metabolize other drugs such as anticonvulsants causing further health risks. In the heart, the accumulation of the drug may cause side effects such as slowed heartbeats, decreased ability of the heart to contract properly, and interruption of electrical impulses transmitted in the heart. The drug’s build up may also result in causing an accidental overdose, especially in those patients who are elderly that are already suffering from respiratory and/or heart conditions.
Dr. Wolfe is recommending that the drug be removed gradually to give time for those people dependent on it to find safer alternatives. If you or a family member are currently taking Darvon®, Darvocet® or a generic form of propoxyphene, you should consult with your healthcare professional to explore alternative pain treatment drugs.
If you or a family member have suffered heart problems or other side effects from taking Darvon® or other drugs containing propoxyphene, you may wish to contact an attorney to discuss your legal rights. Please contact our knowledgeable attorneys at Brayton Purcell for a free evaluation of your potential case.
