If the British recognize that the drug propoxyphene is too dangerous to prescribe to patients, what’s keeping Americans from realizing the same thing?
The U.K. began a phased withdrawal of Darvocet, which contains propoxyphene, from the British market in 2005, after the U.K. Committee on Safety of Medicines recommended that they do so. In its report, the CSM stated that it could not “identify any patient group in whom the risk-benefit [ratio] may be positive.” The withdrawal was completed at the end of 2007.
It’s not that Americans haven’t tried to tell the government to pull propoxyphene off drug store shelves. In 2006, Public Citizen petitioned the U.S. Food and Drug Administration to withdraw all drugs containing propoxyphene, including Darvon and Darvocet, from the market because of the drug’s hazardous side effects. However, the FDA still has not granted or denied the petition. So now Public Citizen is filing a complaint in the D.C. District Court in the District of Columbia asking it to compel the FDA to make a decision.
Propoxyphene is an extremely dangerous painkiller. It is physically and psychologically addictive, is no more effective than safer alternatives and has been associated with more than 2,000 accidental deaths in America since 1981. Despite these risks, however, the drug was one of the 25 most prescribed generic drugs last year, with 22 million prescriptions filled in pharmacies in 2007.
Reports on propoxyphene dosage suggest addiction can occur at less than the maximum recommended daily dose and unequivocally confirm addiction at just twice the recommended daily dose. In addition, propoxyphene has been deemed inappropriate for the elderly because of its adverse effects on the central nervous system – such as sedation and confusion – that have been found to increase the likelihood of falls and fall-related fractures. However, studies have shown that propoxyphene use is widespread in emergency rooms, institutionalized populations and retirement communities.
Public Citizen is asking the court to find that the FDA’s delay in ruling on the 2006 petition is unlawful and to order the FDA to issue a decision on the petition. With substitutes for the drug that are equally effective and far less hazardous, the FDA has no reason not to immediately start phasing out propoxyphene from American drug stores.