FDA Pulls Darvon Painkiller Due to Safety Risks

By: AP Email
By: AP Email

WASHINGTON (AP) - The maker of the painkiller Darvon is pulling
the drug off the market at the request of public health officials
who say the more than 50-year-old pill causes potentially deadly
heart rhythms.

The Food and Drug Administration said Friday that Xanodyne Pharmaceuticals had agreed to halt all U.S. marketing of Darvon and
the related brand Darvocet, which have been subject to safety
concerns for decades. The Kentucky company confirmed the move in
its own statement.

The FDA also ordered generic drugmakers to stop making and
selling low-cost drugs containing the active ingredient in Darvon,
called propoxyphene.

Britain and the European Union decided to ban Darvon in 2005 and
2009, respectively, due to a long trend of suicides and accidental

FDA officials said they decided to take action based on a recent
study showing Darvon interferes with the electrical activity of the
heart, causing irregular heart rhythms that can be fatal. Xanodyne
conducted the study last year at the government's request.

"This last study, the cardiac study, was sort of the final
piece of the puzzle that told us what the complete picture was,"
said Dr. Gerald Dal Pan, director of FDA's office of surveillance
and epidemiology.

Dal Pan said patients should continue taking the medication
until their doctor prescribes a replacement therapy. Other commonly
prescribed drugs in the same class are oxycodone and codeine.

But public safety advocates said the agency should have acted
much sooner to pull a drug with limited benefits and a long history
of safety problems.

"The FDA's deadly delay in this case starkly illustrates how
one of the most important public health concepts, the precautionary
principle, was embraced by the UK and Europe, but was for too long
recklessly rejected by the FDA," said Dr. Sidney Wolfe, of the
consumer watchdog group Public Citizen.

Wolfe estimated that at least 1,000 to 2,000 U.S. patients died
from taking Darvon since the U.K. banned the product in January

Public Citizen petitioned the FDA to ban the drug in 1978 and
again in 2006, pointing to its role in thousands of deaths reported
by state medical examiners.

The most recent petition led to a January 2009 meeting, where a
panel of outside experts voted 14-12 to recommend the drug be
pulled from the market.

But the FDA disagreed, and later that year agency officials said
they would keep the drug on the market with a bolder warning label
about the risk of overdosing. Around that time, the FDA asked
Xanodyne to conduct the study of the drug's heart effects.

"For the first time we now have data showing that the standard
therapeutic dose of propoxyphene can be harmful to the heart," Dal
Pan said.

Propoxyphene, which was first approved in the 1957, is an opioid
narcotic used to treat mild to moderate pain. About 10 million
people in the U.S. received prescriptions for Darvon and related
drugs in 2009, according to the FDA.

The most popular form of the drug currently is Darvocet, which
combines propoxyphene with the more common painkiller
acetaminophen. At FDA's 2009 meeting, officials cited studies
showing most of the pain relief from Darvocet came from the
acetaminophen component.

Based in Newport, Ky., Xanodyne Pharmaceuticals is a privately
held company focused on pain relief drugs.

A spokesman for the company said it does not advertise Darvon or
Darvocet, which make up less than 1 percent of the market for
propoxyphene-based drugs. The majority of medicines sold are
generic versions, he said.

In the last two years the FDA has begun prodding drugmakers to
develop more sophisticated pain relievers that are harder to abuse
or misuse. recently developed products include pills that are
formulated to lose their potency if they are crushed or dissolved.

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