Consumer Group Urges Food and Drug Administration to Ban Drug Darvon
Article Outline
This was the headline in USA Today (March 1, 2006). It is among the most frequently prescribed opioid analgesic for the elderly. The advocacy group Public Citizen petitioned that the Food and Drug Administration immediately begin a phased removal from the market. Propoxyphene has been associated with 2110 accidental deaths in the United States between 1981 and 1999.
Because the drug is broken down to a more potent metabolite (norpropoxyphene) that is more toxic than the original drug can lead to problems. Norpropoxyphene is 2.5 times as potent as propoxyphene and has a half-life of 36 hours. The potential for cardiac depression makes this drug dangerous. Given that the drug has been shown to be no more effective than two aspirins or 1000 mg of acetaminophen, why prescribe it? Its depressant effects on the central nervous system combined with possible toxic metabolites can subject the elderly to falls and possible fractures.
The drug also has evidence of addiction. For the elderly, long-term use can cause dependence and withdrawal symptoms after discontinuation of the drug. In addition to addiction problems, the elderly are subjected to greater buildup of the cardiotoxic metabolites.
Caterino, Emond, and Camargo (2004) surveyed emergency departments across the United States from 1992 to 2000. They noted 16.1 million inappropriate medications were administered to elderly (≥65 years) patients. Six drugs accounted for 70.8% of the inappropriate medications. Propoxyphene accounted for 17.2% behind promethazine (22.2%) and meperidine (18%).
Lau, Kasper, Potter, and Lyles (2004) surveyed a nationally representative sample of nursing homes to estimate the scope of potentially inappropriate medication prescriptions. They reported that at a minimum of 50% of all residents aged 65 years and more with a nursing home stay of 3 months or longer received at least one inappropriate prescription. Propoxyphene topped the list, but the researchers did not relay any particular order in naming the list of inappropriate prescriptions.
The literature is replete with studies, case reports, and comments about the dangers of propoxyphene, especially among the elderly. The American Geriatric Society recommends that this drug not be given to the elderly. Advocacy groups such as Public Citizen have made the same recommendation and petitioned the Food and Drug Administration to begin a phased removal of propoxyphene. What should we be doing about this?.
References
- . Inappropriate medication administration to the acutely ill elderly (a nationwide emergency department study, 1992-2000) . Journal of the American Geriatric Society . 2004;52(11):1847–1855
- . Group urges FDA to ban drug Darvon . USA Today . 2006;D7; March 1
- . Health Service Research . 2004;39(5):1257–1276
- Public Citizen. Retrieved March 1, 2003, from http://www.citizen.org/publications/release.cfm?ID=7420
PII: S1524-9042(06)00035-X
doi:10.1016/j.pmn.2006.03.001
© 2006 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

