(Feb. 28, 2006)--A research group said Tuesday it plans to submit a petition to the Food and Drug Administration, seeking a federal ban on painkillers it says have been associated with the deaths of more than 2,100 people between 1981 and 1999.
The director of the Public Citizen's Health Research Group says the main ingredient in drugs such as Darvon and Darvocet, propoxyphene, is a relatively weak painkiller and poses an unacceptable toxic risk to patients.
The petition says that since 1999, several hundred more people have died accidentally after taking the drugs each year.
“The number of deaths involving propoxyphene in the U.S. alone is striking,” says the petition, filed by Public Citizen and two Swedish experts on propoxyphene.
“The Food the Drug Administration should immediately begin phasing out the use of propoxyphene,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group.
“Millions of people, many of them elderly, are being put at risk when using this drug when there are safer, more effective alternatives available.”
Doctors wrote 23 million prescriptions for drugs containing propoxyphene last year.
The British government announced a phased removal of the drug from the market last year, Public Citizen said, because risks outweigh benefits.
The FDA says it does not comment on petitions.
It has 180 days to respond to petitioners.
Click Here For Public Citizen Web Site
Click Here For FDA Web Site