Failure to Act on Painkiller Petition Puts FDA Under Fire in New Lawsuit
A suit has been brought against the U.S. Food and Drug Administration (FDA) for violating the law in not acting on a petition in a timely manner.
Two years ago, Public Citizen sued the FDA to withdraw the painkillers Darvon® and Darvocet® from the market and the FDA has not acted on this petition. According to the lawsuit filed in U.S. District Court for the District of Columbia, the FDA is putting the public at risk by allowing these drugs to remain on the market.
Darvon and Darvocet both contain propoxyphene, a drug that is known to be both physically and psychologically addictive. The suit claims that the drug is no more effective than safer alternatives on the market and has been associated with more than 2,000 deaths in the U.S. since its launch in 1981. Despite health risks associated with the drug, it was the 25th most prescribed generic drug on the market last year with more than 22 million prescriptions filled in American pharmacies in 2007.
The Public Citizen petition of 2006 was seeking the gradual withdrawal of all products containing propoxyphene from the U.S. market as has now been required in the United Kingdom. The phased withdrawal of Darvocet from the British market began in 2005 following the recommendation of the U.K. Committee on Safety of Medicines (CSM). A CSM report concluded at the time that it could not “identify any patient group in whom the risk-benefit ratio may be positive” for Darvocet. The complete withdrawal of this drug from the market was achieved by the end of 2007.
Three years after the British government began to withdraw Darvocet and two years after Public Citizen petitioned to initiate phase out here, the FDA has done nothing to protect Americans from the dangerous side effects of propoxyphene, the suit alleges. The main reason for this request is that the drug is considered to be highly toxic to the heart and can lead to interruption of heart transmission of electrical impulses, slowed heartbeat and a decreased ability of the heart to contract properly. Depression is another side effect of the drug.
Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen said, “Top FDA drug officials, including Center for Drug Evaluation and Research Director Dr. Janet Woodcock and Dr. Robert Temple, are well aware that this drug has considerable human toxicity, addiction potential and abuse liability, but very limited therapeutic usefulness. Given this extremely unfavorable ratio of risks to benefits, it is inexcusable that the FDA did not take propoxyphene off the market long ago. It is our hope that his lawsuit will force the agency to finally begin this desperately needed regulatory process.”
Public Citizen is a national, nonprofit consumer advocacy group founded in 1971 to represent consumer interests in Congress, the executive branch and the courts.