Darvon and Darvocet Recall
Failing to remove a dangerous product from the market can have severe health consequences. But it is even worse when the withdrawal effort could have come much sooner and some of the health issues prevented. Xanodyne Pharmaceuticals Inc. which makes Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, recently agreed to withdraw the medication from the U.S. market. The withdrawal came at the request of the FDA. The FDA sought withdrawal of propoxyphene after the agency received new clinical data that showed that propoxyphene-based drugs puts patients at risk of potentially serious or even fatal heart arrhythmia. After weighing the benefits and risks of the drug, the FDA determined that the serious heart risks, combined with the risks of suicide, addiction and death outweighed the potential benefits of the drug as a painkiller. However, despite the FDA’s decision to request the withdrawal at this time, the consumer watchdog Public Citizen blasted the FDA for waiting too long before issuing a Darvon and Darvocet recall late last week.
Earlier Complaints Ignored
Propoxyphene, which is contained in Darvon and Darvocet, is an opioid used to treat mild to moderate pain. Darvon was first introduced in 1957. Now, the drug is most commonly prescribed as Darvocet, which combines the active ingredient in Darvon with acetaminophen, the active ingredient in Tylenol. Darvocet’s use is not limited to a small number of people. In fact, it has been prescribed for more than 22 million people and is one of the 25 most commonly used prescriptions.
The widespread use makes the FDA’s slow reaction time even more devastating. Public Citizen released a statement this past Friday stating that the delay may have resulted in 1,000 to 2,000 additional Darvon and Darvocet deaths during the years after the FDA should have recalled all propoxyphene drugs. Public Citizen first petitioned the FDA for a Darvocet and Darvon recall in 1978. At that time, there was already evidence of the adverse health effects Darvon and Darvocet could have on the heart. But the earlier warnings did not end there. The U.K. decided to pull Darvocet and Darvon from that market in January 2005, after determining the drugs were too dangerous and had little benefit. Public Citizen petitioned the FDA for a recall again in 2006, but again to no avail. It then filed a lawsuit against the FDA in 2008 following the FDA’s refusal to act on its petition.
It was not until after that lawsuit that the FDA’s own advisory committee voted for a recall in January 2009 for the same reasons as the UK. The FDA defended its decision to wait however, saying that it only recently received enough data to justify that the risks of Darvon and Darvocet side effects outweighed its health benefits.
What the Future Holds
There is a small bright spot for some patients. “With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart,” said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology, CDER. “However, long-time users of the drug need to know that these changes to the heart’s electrical activity are not cumulative. Once patients stop taking propoxyphene, the risk will go away.”
Dr. Sidney Wolfe, director of Public Interest’s health research wing, wasn’t focusing on the limited bright side and instead had some harsh words for the FDA. “Due to FDA negligence, at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene since [the] time the UK ban was announced,” Wolfe said. “The FDA’s pitiful excuse that it needed to order a human study to find that ‘the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities’ before deciding whether to ban propoxyphene only emphasizes how out-of-step the agency is with the rest of the world – which already had enough human evidence of death and near-death in tens of thousands of people to act accordingly.”
Consumers who have been harmed by Darvon or Darvocet should not just accept their health issues. Whether or not the FDA or Xanodyne acted negligently remains to be determined. Public Citizen has called for a congressional investigation into the agency’s negligence, but patients should not wait for the results of that potential investigation. The time to contact a lawyer and explore all potential remedies is now.