Other News Group sues FDA for inaction over its petition to ban risky painkiller
By Sue Mueller
Jun 20, 2008 - 8:12:14 AM
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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 early petition to pull a
prescription painkiller off from 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 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 the concerned
painkiller 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 additive and it can
slow heartbeat and other serious cardiac adverse responses even when used
properly, according to the lawsuit.
Because of side effects, the drug is believed to be inappropriate
of the elderly.
And it can cause
sedation and confusion that increase risk of falls and fractures, both are a
risk for the group.
The UK ordered the drug phased out in 2005 based on the fact
that it was associated with a few hundreds of accidental deaths and suicides
each year.
In the US, doctors wrote 22 million prescriptions for the
medication last year, one of most commonly used generic prescription drugs.
Manufacturers and FDA did not make comments in response to
the lawsuit.