Ban Darvocet: The Pain-killer That Kills! sign now

Lets ban Darvocet: The pain-killer that Kills!

"Darvon, Darvocet and related painkillers should be phased out and eventually banned, a watchdog group said Tuesday in a government petition that cited the accidental deaths of at least 2,110 people between 1981 and 1999.

Several hundred more people have died accidentally after taking the prescription narcotics each year since, Public Citizen's Health Research Group said in the petition faxed to the Food and Drug Administration. A roughly equal number of people used the drug to commit suicide.

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. Propoxyphene has been sold since 1957. Public Citizen first sought to ban it in 1978.

"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 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.

A phase-out, meant to wean users from the addictive drug, and eventual ban if approved, would follow a similar decision made in January 2005 by the United Kingdom. Health officials there said at the time that the drug was associated with 300 to 400 accidental deaths and suicides each year.

In the United States, 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. It is sold in multiple generics versions as well.

A recent 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.

"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.

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 said in a statement that it intends to file a "substantive response" to the petition as soon as practicable.

A spokesman for Mylan Pharmaceuticals Inc., one of the larger of the dozen-plus manufacturers of generic drugs containing propoxyphene, did not return an e-mail seeking comment on the petition. 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."- The Associated Press.

I, Patricia McClain,made this petition out of love for a friend. My friend Renee, also known as Waya, miscarried and lost her child because of Darvocet. A painkiller that kills is not a "pain-killer" at all, just a killer. Lets ban Darvocet and all related drugs so there'll be no more deaths, and no tragedies like Renee's daughter. Please help us get Darvocet off the market for good.

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