Darvon and Darvocet Recall Not Issued by FDA Despite Recommendations

Harvey Kirk

By Harvey Kirk
Posted July 8, 2009


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.


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.

5 Comments • Add Your Comments

  • Carolyn says:

    Every painkiller has side effectes to a minimal number of people. It is not near as dangerous as Oxycontin or Lortab.

    The FDA needs to pull their head out of their butt!!!!!!!!!!!!!!!!!!!!!

    Doesn’t the good outweigh the bad?

    Posted on November 21, 2010 at 10:50 am

  • Marge says:

    First Vioxx, now Darvocet. Is there anything else you would like off the market that helps with pain? I use painkillers sparingly, but do need them and many do not work. People who abuse these drugs make the rest of the population suffer and have to do without. Perhaps closer monitoring of quantities by the pharmacies and doctors would eliminate some of these problems. I personally have a contract with my physician that I will limit the use, and in two years have not broken that contract.

    Posted on December 9, 2010 at 11:50 pm

  • Janet says:

    Darvocet is not as scary as taking something more addicitve like Lortab or any other codeine or morphine product!!!! When taken as directed the good does ooutweigh the bad!

    Posted on December 10, 2010 at 4:38 pm

  • Shirley says:

    Seriously, who in this day and age that has ever been prescribed any medication – precscription or OTC – does not understand that there are potential side effects? Is that not why there are laws requiring a doctor’s prescription for specific medications…aside from two of the most addictive and harmful drugs alcohol and tobacco? I know that’s a different branch of the government and I admit, I have used Darvocet safely for over 30 years…it’s the only thing that manages my chronic pain without doping me into oblivion. Tylenol alone does not help me and I, like numerous others can no longer take aspirin, advil, alleve because they cause bleeding problems.
    My guess is that this has more to do with money and lawsuits than it has to do with protecting the public.

    Posted on December 14, 2010 at 1:10 am

  • jr23 says:

    can;t believe the FDA recommends to replace Darvon etc with Oxycontin and oxycodone 2 possible addictive and very abused drugs over a low addictive rarely abused

    Posted on May 2, 2013 at 12:30 am

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