FDA Advisory Committees Vote to Ban Propoxyphene Products

FDA Advisory Committees Vote to Ban Propoxyphene Products


Joint meeting of Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees determines risks outweigh benefits of Darvon and Darvocet.

FDA’s Anesthetic and Life Support Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee held a joint meeting January 30 to discuss the safety and efficacy of propoxyphene (Darvon) and propoxyphene-combination products. Committee members voted 14 to 12 to recommend that FDA discontinue marketing these products.

An introductory memo to meeting participants from Bob Rappaport, MD, Director of the Division of Anesthesia, Analgesia, and Rheumatology Products in FDA’s Center for Drug Evaluation and Research, included the following:

  • There is insufficient evidence to establish that propoxyphene alone is an effective analgesic.
  • The Committee on Safety of Medicines, under the Medicines and Healthcare Products Regulatory Agency of the UK, determined that the risk of deliberate and accidental overdose was unacceptably high and the product should be withdrawn from the UK market.
  • Propoxyphene and its major metabolite are potent cardiotoxic agents with a narrow therapeutic index.
  • Propoxyphene is widely prescribed, especially in the elderly, and has been associated with a large number of deaths.

The re-evaluation of propoxyphene came about in response to a Public Citizen petition file in February 2006, which stated, “Propoxyphene (now sold mainly as a generic drug), … has been associated with 2110 reported accidental deaths in the U.S. from 1981 through 1999.”

Representatives from FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA) presented data on the efficacy and safety of propoxyphene documented in the New Drug Applications for the products and in the medical literature, as well as adverse event data from FDA’s Adverse Event reporting System and from SAMHSA’s Drug Abuse Warning Network (DAWN). Members also reviewed outpatient prescription usage data.

Xanodyne Pharmaceuticals, Inc., and Qualitest/Vintage Pharmaceuticals argued that the Public Citizen Petition “did not present credible scientific evidence that propoxyphene drugs are unsafe or ineffective when used according to approved labeling.” They maintained that the safety and efficacy of the product had been reaffirmed over the years with the approval of new formulations, new strengths, and new combination products. Their summary document stated, “[The] risks have not prevented the safe use of propoxyphene in accordance with the approved prescribing information,” and reminded committee members that safe use of the drug is safeguarded by its classification as a Schedule IV drug under the Controlled Substances Act.

FDA is not required to follow the joint committee recommendation.

Note*  I hope they are successful in removing propoxyphene in all forms from the market.  I have seen several patients highly addicted to it over the years.