The pain-killing drugs Darvon, Darvocet and their generic ingredient propoxyphene are being removed from the market because of serious heart risks, the Food and Drug Administration announced on Friday.
The agency recommended that doctors and pharmacists immediately stop prescribing the drug and contact patients to advise them to throw it away and switch to another pain-killer.
Dr. Sidney Wolfe, director of the Public Citizen’s Health Research Group, who had petitioned the F.D.A. to ban the drug in 1978 and 2006, said the delay has cost more than 1,000 American lives. Dr. Wolfe, in a statement, asked for a congressional investigation into the delay.
Last year, an F.D.A. panel of experts voted 14-12 to recommend the drugs’ removal.
Since 2005, about 120 million prescriptions have been filled in the United States for the drugs, Dr. Wolfe said. Propoxyphene drugs are among the 40 most commonly prescribed drugs in the United States, government and company officials say, with more than 23 million prescriptions written in 2007. They have been sold since 1957 and are popular with older Americans. Their usage has waned due to newer drugs for moderate pain.
Gerald Dal Pan, director of the agency Office of Surveillance and Epidemiology, said in a conference call with reporters that about 10 million Americans received the prescriptions in 2009.
Great Britain had banned the drugs in 2005, and the European Union followed in 2009, based partly on evidence from Florida where medical examiners were reporting excess deaths from people who
used it.
The F.D.A. in a MedWatch report Friday said a new study showed Darvon usage at therapeutic doses caused significant changes to electrical activity of the heart.
The agency recommended that doctors and pharmacists immediately stop prescribing the drug and contact patients to advise them to throw it away and switch to another pain-killer.
Dr. Sidney Wolfe, director of the Public Citizen’s Health Research Group, who had petitioned the F.D.A. to ban the drug in 1978 and 2006, said the delay has cost more than 1,000 American lives. Dr. Wolfe, in a statement, asked for a congressional investigation into the delay.
Last year, an F.D.A. panel of experts voted 14-12 to recommend the drugs’ removal.
Since 2005, about 120 million prescriptions have been filled in the United States for the drugs, Dr. Wolfe said. Propoxyphene drugs are among the 40 most commonly prescribed drugs in the United States, government and company officials say, with more than 23 million prescriptions written in 2007. They have been sold since 1957 and are popular with older Americans. Their usage has waned due to newer drugs for moderate pain.
Gerald Dal Pan, director of the agency Office of Surveillance and Epidemiology, said in a conference call with reporters that about 10 million Americans received the prescriptions in 2009.
Great Britain had banned the drugs in 2005, and the European Union followed in 2009, based partly on evidence from Florida where medical examiners were reporting excess deaths from people who
used it.
The F.D.A. in a MedWatch report Friday said a new study showed Darvon usage at therapeutic doses caused significant changes to electrical activity of the heart.
