foodconsumer.org: Group sues FDA for inaction over its petition to ban risky painkiller

Group sues FDA for inaction over its petition to ban risky painkiller
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admin on 06/20/2008 17:38:00
 
FRIDAY JUNE 20, 2008 (foodconsumer.org) -- A prominent consumer group Thursday
filed lawsuit against the Food and Drug Administration over the agency's delay
in response to its earlier petition to pull a prescription painkiller off the
marker, The Associated Press reports.
Public Citizen said in the suit that the painkiller sold under such names as
Darvon and Darvocet is too dangerous to stay on the market.
The suit was filed in U.S. District Court in Washington alleging that the FDA
has violated the law by not ruling on its petition within six months.
Two years ago, a petition was filed by the group to ask the FDA to ban the drug,
arguing that safer drugs are available and that the painkiller in question has
caused more than 2,000 accidental deaths since 1981.
The drug of concern is a narcotic called propoxyphene, made and sold by many
generic manufacturers in addition to companies that sell the drug under the
brand names Darvon and Darvocet.
Dr. Sidney Wolfe cited a recent review of studies saying that ibuprofen worked
better for most cases of pain, The AP reports.
One downside is that propoxyphene is addictive; it can also slow down the
heartbeat and cause other serious cardiac adverse responses even when used
properly, according to the lawsuit.
Because of the side effects, the drug is believed to be inappropriate for the
elderly.   And it can cause sedation and confusion that increase the risk of
falls and fractures, both of which are already a risk for this group.
The UK ordered the drug phased out in 2005 based on the fact that it was
associated with a few hundred accidental deaths and suicides each year.
In the US, doctors wrote 22 million prescriptions for the medication last year,
one of the most commonly used generic prescription drugs.
Manufacturers and the FDA made no comments in response to the lawsuit.
By Sue Mueller, and edited by Heather Kelley.
Jun 20, 2008 - 8:12:14 AM