FDA Panel Urges Darvon BanFeb 2, 2009 | Parker Waichman LLP The Darvon debate continues, but U.S. Food and Drug Administration (FDA) advisors are recommending the painkiller be pulled from the market. USA Today reported that following a hearing about the popular pain drug, a FDA panel voted to withdraw the drug in a 14-to-12 vote.
Darvon, known generically as Propoxyphene Hydrochloride, is also prescribed as Darvocet, which contains the active ingredient in Tylenol, reported USA Today. At issue, is that consumer groups feel the drug does not provide effective pain relief and could, therefore, lead to overdose risks. Drug makers disagree, reported USA Today, and maintain that, when used as directed, Darvon is safe and effective.
And, while the panel voted that Darvon’s benefits don’t outweigh its risks, said the Wall Street Journal, the decision remains with the agency, which is known for agreeing with panel decisions, but not when the vote is this close.
Darvon has been on the market for over 50 years, since 1957. In 2007 alone, over 20 million prescriptions were written for propoxyphene medications, said the WSJ. Over 600 million prescriptions have been written for the drug since its introduction, said Dow Jones. Congressional hearings on the Darvon’s safety and efficacy began 30 years ago and critics have long claimed that the drug is responsible for accidental overdoses and suicides, said the Journal. Consumer advocacy group, Public Citizen, has been working to ban Darvon for decades and is responsible, with its petition and an ensuing lawsuit, for bringing about the recent FDA move.
Sidney Wolfe, a doctor at Public Citizen said of Darvon that, "Claims of its efficacy have been seriously undercut by the FDA's own analysis," adding that Darvon "possesses weak analgesic effects." Wolfe presented data last week revealing that over 500 deaths took place in 2007 in which propoxyphene was involved, reported the WSJ. "All drugs have risks," Dr. Wolfe said. "If they don't have benefits they need to come off the market," quoted the WSJ.
Today, the Darvon and Darvocet are manufactured and marketing by private, generic drug makers such as Xanodyne Pharmaceuticals Inc. of Newport, Kentucky and Qualitest/Vintage Pharmaceuticals, of Huntsville, Alabama, said Dow Jones. Approved for mild to moderate pain, the propoxyphene medications have been linked to death in patients—especially when used with alcohol and other drugs—and have also been found to be addictive. According to FiercePharma, it is because of the potential abuse that the FDA advisory committee was been called in to help determine if the drugs should or should not remain on the market.
The Public Citizen petition followed the United Kingdom ban of propoxyphene pain killers over concerns of abuse and fatalities linked to the drugs, said the WSJ. Dow Jones reported that an FDA review of its adverse-event reporting data base confirmed 3,028 serious and non-serious reports linked to propoxyphene from 1957 through September 24, 2008; 2,136 reports were considered serious and 1,452 ended in death. The FDA noted that much of the reports involved suicides, intentional and unintentional drug overdoses, and heart attacks.