by Playfuls Staff |
28th February 2006
Public Citizen petitioned the U.S. Food and Drug Administration (FDA) to immediately begin to phase out the widely prescribed pain reliever propoxyphene (Darvon, Darvocet and generic versions) from the market because the drug has been associated with more than 2,000 accidental deaths, is physically addictive and is no more effective than safer [more] alternatives.
Data from the Federal Drug Abuse Warning Network, which provides autopsy information from medical examiners in the United States, has found that 5.6 percent of all drug-related deaths were related to propoxyphene during the past 19 years. In 2004, 23 million prescriptions for propoxyphene were filled, making it the 12th most commonly prescribed generic drug in the United States. Four companies – Mylan, Mallinkrodt, Teva and QLT – account for more than 91 percent of U.S. prescriptions.
Propoxyphene has been associated with 2,110 reported accidental deaths in the United States since 1981. A large proportion of these deaths occur because most of the drug is converted into a metabolite that is highly toxic to the heart and lasts longer in the body than the original compound, resulting in cardiac depression. Adverse cardiac events associated with propoxyphene include an interruption of heart transmission of electrical impulses, slowed heartbeats and a decreased ability of the heart to contract properly.
In addition, popoxyphene has been deemed inappropriate for prescription for the elderly because of central nervous system-related adverse events – such as sedation and confusion – that have been found to increase the likelihood of falls and fall-related fractures in the elderly. Studies have shown that propoxyphene use is widespread in the institutionalized population, in emergency rooms and in community-dwelling older people, populations in whom propoxyphene is most dangerous.
Public Citizen is calling for the drug to be phased out, rather than banned immediately, because of its addictive quality.
Public Citizen has a strong track record of identifying dangerous drugs well before federal regulators take action to ban or put warnings on these drugs. For example, Public Citizen warned consumers about the dangers of Vioxx, ephedra, Bextra, Rezulin, Baycol, Propulsid and many other drugs years before the drugs were pulled from the market.
