Darvon and Darvocet Recall Not Issued by FDA Despite Recommendations
UPDATE NOVEMBER 2010: The FDA recalled Darvocet and Darvon on 11/19/2010, indicating that data now links the medications to a potential risk of heart arrythmias, in addition to other side effects, such as suicide, overdose and death. Potential lawsuits are being reviewed by the Darvocet lawyers and Darvon lawyers at Saiontz & Kirk, P.A. for individuals who may be entitled to compensation for an injury or death.
Going against the recommendations of their own advisory panel and disregarding a 2006 petition filed by the consumer advocacy group Public Citizen, the FDA announced Tuesday that Darvon and Darvocet side effects do not justify a ban on the painkillers. Instead, the agency will require manufacturers of all propoxyphene-based medications to carry more stringent “Black box” warnings to alert users of the risk of overdose and death.
Public Citizen filed a petition calling for the FDA to require a Darvon and Darvocet recall in 2006, and followed that up with a lawsuit filed last summer against the FDA for failing to act on their petition.
Earlier this year, an FDA advisory committee met and evaluated the safety and risks associated with the powerful painkillers. In the wake of data from Europe that linked Darvon and Darvocet to hundreds of accidental and intentional drug overdoses, the FDA panel voted to recommend the agency withdraw approval for the drugs.
While the FDA usually follows the recommendations of their advisory panels (and they also usually end up acting in accordance with Public Citizen petitions; see the Botox warnings and Levaquin tendon rupture warnings), they are not required to do so. In a statement released yesterday, the FDA said it uses a different measuring stick for determining the benefits and risks of drugs than the advisory committee and Public Citizen:
There are differences in how FDA and those who support the market withdrawal of propoxyphene view the benefit and safety data of this drug. FDA finds there is evidence that propoxyphene can effectively treat pain at recommended doses. FDA also finds that the differences in use patterns between Europe and the United States limit the applicability of the European data to the U.S. population. The U.S. data available to date do not confirm the European findings. Because these data are limited, however, FDA is further investigating the safety concerns with propoxyphene in the United States.
Propoxyphene was first approved for use in medications in 1957. It is an opioid that is used as a painkiller. The new labeling requirements on the medications will include a boxed warning of the risk of overdose, and information in medical guides on overdose risk and the importance of taking proper dosages.
The FDA’s decision may provide some insight into how the agency will handle recent recommendations by its advisory panel that called for a recall of Percocet, Vicodin and other painkillers that contain acetaminophen. The panel narrowly voted that the drugs were dangerous enough that they should be removed from shelves. That panel also voted to restrict the dosage of acetaminophen-based over-the-counter medications, like Tylenol and NyQuil, to 325 milligrams per day.
DARVOCET AND DARVON LAWSUITS
The product liability lawyers at Saiontz & Kirk, P.A. are evaluating the potential for Darvocet and Darvon lawsuits for individuals who have suffered fatal or catastrophic injuries as a result of an accidental overdose. If you, a friend or family member experienced problems as a result of the drugs or other painkillers that contain propoxyphene, request a free consultation and claim evaluation.