WATCHDOG GROUP SEEKS FEDERAL BAN ON DARVOCET AND RELATED PAINKILLERS

WASHINGTON -- 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.