Need Counsel After Taking Darvocet?
Defective and Dangerous Drug Lawyers in New York City
On November 19, 2010, the Food and Drug Administration ("FDA")
banned the sale of the pain killers Darvon and Darvocet in the United
States after cardiac studies ordered in 2009 demonstrated they increased
the risk of potentially fatal heart arrhythmias in healthy patients taking
the medication in recommended doses. It has also ordered makers of the
generic version of this drug's core compound, propoxyphene, to stop
selling the drug.
Since 2001, our
Darvocet lawyers at Sullivan & Brill, LLP have been helping New Yorkers receive just
compensation for injuries sustained or loved ones lost due to dangerous
drugs such as Darvon or Darvocet.
Call our firm now for a
Darvon and Darvocet are opioid narcotics used to treat mild to moderate
pain. Darvon is the brand name for propoxyphene and Darvocet is the brand
name for propoxyphene mixed with acetaminophen. These pain killers were
approved by the FDA in 1957, but have been plagued by safety concerns
ever since. In addition to the increased risk of heart arrhythmias, the
drug has been linked to increased risk of suicide and accidental overdoses.
This dangerous drug also has an unusually high death rate of 16 deaths
for every 100,000 prescriptions. Public Citizen, a consumer advocacy group,
petitioned the FDA to pull the drug from the market in 1978 and again
in 2006, but the FDA declined stating that the drug's benefits outweighed
Effects and Regulations
The introduction of safer drugs and additional studies of Darvon and Darvocet
since 1978 have changed the cost benefit analysis. According to a statement
issued by Dr. Sidney Wolfe of Public Citizen "Evidence going back
more than 30 years indicates that propoxyphene is not very effective,
is toxic at doses not much higher than the recommend dose," and is
"somewhat addictive." The New York Times reported that "Propoxyphene
has been shown to have very little effect on pain. Many studies showed
no significant improvement by adding it to acetaminophen. Propoxyphene
also has a narrow margin of safety between the recommended dose and a
harmful dose or fatal overdose, according to the FDA review and other
The drug was pulled from the British market by its regulatory agency in
2005 and by the European Union in 2009. In 2009, an FDA advisory committee
voted 14-12 to ban marketing of the drug in the United States, but the
FDA rejected the recommendation and ordered further studies of the drug.
The results of these studies, conducted by the drug's manufacturer,
Xanodyne Pharmaceuticals Inc., of Newport, Kentucky at the direction of
the FDA, have now led the FDA to ban these dangerous drugs. However, the
FDA's approach toward removal of dangerous drugs from the market,
which allows a drug to continue to be sold while its risks are being studied,
has likely led to 1000 to 2000 unnecessary deaths since 2005 when it was
pulled from the UK market, estimates Dr. Sidney Wolfe of Public Citizen.
Doctors have been advised to immediately stop prescribing the drug and
patients have been advised to continue taking it, but to immediately see
their doctor to arrange for an alternative medication. The FDA estimates
that 10 million prescriptions of Darvon and Darvocet where written in
the United States in 2009 and SDI / Verispan indicates that 17.5 million
prescriptions of the generic version were written in 2009. According to
Dr. Farrar, chairman of the FDA advisory panel that recommended the drug's
ban in 2009, and Dr. Wolfe, Extra Strength Tylenol may be the best alternative.
Other alternatives, for patients in worse pain, include the opioids Tramadol
and low-dose hydrocodone or oxycodone.