A Food and Drug Administration (FDA) advisory panel voted 14-12 to recommend withdrawing Darvon, a prescription drug used to treat pain for more than 50 years. Darvon has been linked to such problems as addiction and suicide. The decision followed a daylong hearing that analyzed the risks and benefits of the medication. The FDA is not required to follow the panel’s recommendation, although the agency usually does.
Darvon was initially approved in 1957 at a time when there were very few alternatives to treat pain, except aspirin and powerful narcotics. The medication is mainly marketed as Darvocet and is one of the top 25 most commonly prescribed drugs. In 2007, more than 20 million prescriptions were written.
Public Citizen, a consumer group, petitioned the FDA to ban Darvon because the medication offers fairly weak pain relief and has a risk of overdose. The group also argued that Darvon has the potential to be used in suicides.
“With a drug that has almost no evidence of benefit, any risk is unacceptable. Hopefully the FDA will follow the vote of its advisers,” said Dr. Sidney Wolfe, a drug safety expert with Public Citizen who first pursued a ban in the 1970s.
According to two companies that market the drug, Darvon is safe and effective when used as directed.
Darvocet is the widely used combination drug of Darvon and acetaminophen. Most studies have shown that the Darvon component appears to contribute “little or no” additional pain relief beyond that provided by the acetaminophen component. An analysis prepared for the hearing stated that Darvon is a weak pain reliever.
Other actions may be taken if the FDA decides not to ban the drug, including requiring stiffer warnings, safety studies or special education efforts designed for doctors and patients.