Wednesday, July 8, 2009
Melvin Baker - AHN Reporter Washington, D.C. (AHN) - Resisting a call to ban the painkilling drugs Darvon and Darvocet, the Food and Drug Administration on Tuesday decided instead to strengthen warning labels and to begin a study that may result in additional restrictions.
The primary ingredient in both drugs is propoxyphene, which the FDA said had been linked to fatal overdoses.
The agency moves will require drug makers to add language to warning labels that emphasize the potential for overdose. A medication guide also will be included in packaging that advises the correct dosage.
Makers of the drugs also must begin a study "assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses," according to an FDA statement.
"Physicians need to be aware of the risk of overdose when prescribing these drugs. They should carefully review patient histories and make appropriate treatment decisions based on the warnings and directions stated within the drug's label," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research said in a statement.
The FDA action rejected a petition by the group Public Citizen to gradually withdraw propoxyphene from the market.
Public Citizen says the drug has been linked to more than 2,100 accidental deaths in U.S. between 1981 and 1999.
In testimony before the FDA in January, Dr. Steven Wolfe of Public Citizen said that if propoxyphene came up for approval today, it would b erejected because it had "one of the most unfavorable benefit-to-risk ratios ever seen for a drug."
Dr. Steven Karch, a former medical examiner, told the FDA that the efficacy of propoxyphene" is poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable."
Propoxyphene has been on the market since 1957. Public Citizen began pushing for the drug to be banned or its use severely restricted in 1978.
No comments:
Post a Comment