Darvocet®, manufactured by Kentucky-based Xanodyne Pharmaceuticals, has been pulled from the market at the request of the U.S. Food and Drug Administration (FDA).
The drug is a compound consisting of propoxyphene and acetaminophen. Darvon® is another propoxyphene preparation, which has no other active ingredient.
Propoxyphene can result in serious, sometimes fatal, abnormal heart rhythms, according to the FDA, which based its decision on new studies of the medication. The federal agency asked manufacturers of generic forms of the medication to withdraw their products also.
Propoxyphene also is sold under the names Dolene®, Propacet® 100, Wygestic®, SK-65, SK-65 APAP, Trycet Genagesic®, E-Lor®, and Balacet®.
New Study Data
Data from the new studies show that propoxyphene can cause serious, potentially fatal, changes in the electrical activity of the heart. A patient’s risk for these serious heart rhythm changes can occur at any time, even after prolonged use of the drug.
“These new heart data significantly alter propoxyphene’s risk-benefit profile,” said Dr. John Jenkins of the FDA’s Center for Drug Evaluation and Research. “The drug’s effectiveness in reducing pain is no longer enough to outweigh the drug’s serious potential heart risks.”
“Too Little Too Late”
The action was too little too late, according to Dr. Sidney Wolfe, of the Public Citizen’s Health Research Group (PCHRC).
Britain banned propoxyphene-containing drugs in 2005. In 2009, the European Medicines Agency (similar to our FDA) recommended the drug be gradually removed from the European Union Market. The agency concluded that the potentially fatal risks to the heart outweighed any pain-relieving benefit.
There is some discrepancy between the views of the PCHRC and the FDA.
Dr. Gerald J. Dal Pan, director of the FDA’s Center for Drug Evaluation and Research, said the “for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart.”
“Due to FDA negligence,” said Dr. Wolfe, “at least 1,000 to 2,000 or more people in the United States have died from using propoxyphene since the time the U.K. ban was announced.”
Some More Susceptible to Harm
The risk of heart problems is greater in some patients. They include—
- Patients with impaired kidney function
- Patients taking other medication that can affect the heart
- Patients taking medications that can affect the breakdown (metabolism) of propoxyphene
Stopping the medication can have side effects, so patients should speak with their doctors before stopping the medication. These side effects can be:
Darvon® was developed by Eli Lilly and Co. and was approved by the FDA in 1957. In 2009, about 10 million Americans took a prescription drug containing propoxyphene.
If you or someone you love has been harmed by Darvocet®, you should seek the advice of an attorney who is an expert in pursuing harmful drug lawsuits. Our lawyers at Gacovino Lake & Associates are familiar with the harm Darvocet® can cause and for many years have successfully represented clients harmed by drugs. Contact a Darvocet® attorney today.