Darvon Is Still in the Public Eye
Article Outline
In June 2006, I wrote an editorial about a consumer group urging the Food and Drug Administration (FDA) to ban the drug Darvon (Willens, 2006). On July 7, 2009, the FDA released information about several actions to reduce the risk of overdose in patients using Darvon or Darvocet (U. S. Department of Health and Human Services, 2009). These actions were taken because of data linking propoxyphene and fatal overdoses. To further evaluate the safety of propoxyphene, the FDA plans to work with the Centers for Medicare and Medicaid Services and the Veterans Health Administration to study how often the elderly are prescribed propoxyphene over other analgesics. They were also interested in the difference in the safety profiles of propoxyphene compared with other drugs. On that same date, the FDA denied a citizen petition from the public interest group Public Citizen requesting a phased withdrawal of the drug. The FDA responded that the benefits of using the drug at recommended doses outweighs the safety risks at this time.
The FDA is now requiring a new safety study about the effects of propoxyphene on the heart at doses higher than recommended. Furthermore, the FDA will examine the possibility of reviewing medical examiner data in the Substance Abuse and Mental Health Administration's Drug Abuse Warning Network.
In 2003, K-Pharm Research and Consulting reviewed propoxyphene products for inclusion within Alberta's triplicate prescription program (K-Pharm Research and Consulting, 2003). They reported that deaths typically occur rapidly and have occurred with as little as twice the therapeutic drug level. When taken with alcohol, it can be dangerous and lead to death by accidental poisoning (Jonasson, Jonasson & Saldeen, 2000). These researchers examined the forensic evidence where blood is screened for alcohol and medical drugs. Death certificates were analyzed regarding alcoholism, drug addiction, mental problems, somatic illness, and the cause of death. In blood analyzed during 1992 and 1996, 43% of deaths were classified as suicide and excluded from the study. Alcohol was found in 42% of the remaining 1,016 cases, with almost one-half of these cases (47%) within the last 2 years of the study.
A Google search on December 21, 2009 of Darvon lawsuits yielded 5,200 results. Many of the results are to law firms providing information about the drug and the possibility of death. Many include a form to fill out to have a case reported. Most the services offered were free of charge.
Clearly this drug should be followed, as well as the FDA report or study results from the Centers for Medicare and Medicaid Services and the Veterans Health Administration (VHA) (Veterans Health Administration, 2006). No mention of these studies was noted on the government (VHA or FDA) websites about whether this study is being conducted. We should all keep this in mind and seek the outcomes. Your comments in the form of a letter to the editor are welcome.
References
- U. S. Department of Health and Human Services (2009). FDA takes action on Darvon, other pain medications containing propoxyphene. Retrieved July 7, 2009, from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170769.htm
- . Middle-aged men—A risk category regarding fatal poisioning due to dextropropoxyphene and alcohol in combination. Preventive Medicine. 2000;31:103–106
- K-Pharm Research and Consulting (2003). Review of proproxyphene products for inclusion within Alberta's triplicate prescription program. Sherwood Park, Alberta. (pp. 1–9).
- Veterans Health Administration (2006). Review of the efficacy and safety of propoxyphene. Retrieved December 21, 2009 from http://www.pbm.va.gov/
- . Consumer group urges Food and Drug Administration to ban drug Darvon. Pain Management Nursing. 2006;7(2):43
PII: S1524-9042(09)00134-9
doi:10.1016/j.pmn.2009.12.002
© 2010 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.
