Pubdate: Thu, 02 Mar 2006
Source: North County Times (Escondido, CA)
Copyright: 2006 North County Times
Contact:  http://www.nctimes.com
Details: http://www.mapinc.org/media/1080
Note: Gives LTE priority to North San Diego County and Southwest 
Riverside County residents
Author: Andrew Bridges, Associated Press
Bookmark: http://www.mapinc.org/find?232 (Chronic Pain)

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.
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MAP posted-by: Beth Wehrman