FDA to Ban Pain Drug. Darvon, Darvocet and related painkillers were associated with the deaths of at least 2,110 people between 1981 and 1999, critics said Tuesday in asking the government to ban the drugs.
Several hundred more people have died accidentally after taking the drugs each year since then, Public Citizen’s Health Research Group said in a petition it planned to submit to Food and Drug Administration acting Commissioner Dr. Andrew von Eschenbach.
Dr. Sidney Wolfe, the group’s director, said the main active ingredient in the drugs, propoxyphene, is a relatively weak painkiller and poses an unacceptable toxic risk to the millions of patients prescribed it each year. It’s been sold since 1957.
“This a black-and-white example of a drug where its risks far outweigh its benefits,” Wolfe said. “There’s no excuse for this drug to be around.”
The drug’s popularity has waned, but still doctors wrote 23 million prescriptions for propoxyphene-containing drugs last year. Darvocet, which combines propoxyphene with acetaminophen, is among the best known.
An analysis of 26 studies that compared propoxyphene and acetaminophen with just acetaminophen or a dummy pill found the “narcotic combination offered little benefit over acetaminophen alone” in treating pain.
Propoxyphene provides minimal if any additional analgesia to acetaminophen
“Thus, propoxyphene provides minimal if any additional analgesia to acetaminophen alone and is associated with significant adverse effects. It cannot be recommended for routine use,” Dr. Carolyn Sachs of the University of California, Los Angeles, wrote in her analysis, published in March 2005 in American Family Physician.
Heart problems
A phase-out, meant to wean users from the drug, and eventual ban would follow a similar decision made in January 2005 by the United Kingdom, Wolfe said. Public Citizen first sought to ban propoxyphene in 1978.
The FDA does not comment on petitions, spokeswoman Laura Alvey said. The regulatory agency has 180 days to respond to petitioners.
Wolfe said Public Citizen may not wait before undertaking legal action to get the drug off the market.
The body transforms propoxyphene into norpropoxyphene, which can build up in the body and is associated with a variety of heart problems, including arrhythmia.
Eli Lilly and Co. developed the drug but later sold it to aaiPharma Inc. of Wilmington, N.C. That company sold Darvon and Darvocet last year to Xanodyne Pharmaceuticals Inc. The Newport, Ky., company did not return a call seeking comment.
Mylan Pharmaceuticals Inc., one of the larger of the dozen-plus manufacturers of generic drugs containing propoxyphene, declined to comment without having seen the petition, spokesman Patrick Fitzgerald said. Two others: Teva Pharmaceuticals USA and Tyco Healthcare/Mallinckrodt did not return calls seeking comment.
Propoxyphene is among the nation’s most widely abused painkillers, Substance Abuse and Mental Health Services Administration spokeswoman Leah Young said. A 2004 survey found 21 million people had made “non-medical” use of products containing propoxyphene or codeine, Young said.
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