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TUESDAY, July 7 (HealthDay News) -- Concerns about the possibility of fatal overdoses led U.S. health officials Tuesday to take several steps to limit the risk of using pain medications containing propoxyphene, including Darvon and Darvocet.
Manufacturers must strengthen the labels of propoxyphene-containing products by adding boxed warnings that emphasize the potential for overdose and developing medication guides to be given to each person filling or refilling a prescription.
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The manufacturers must also conduct a new safety study to assess unanswered questions, such as how propoxyphene affects the heart when taken at higher-than-recommended doses, Dr. Janet Woodcock, director of the U.S. Food and Drug Administration's Center for Drug Evaluation and Research, said during a news conference.
The FDA is also working with several health-care organizations to collect additional safety data on these products, Woodcock said, adding that "the data we accumulate could result in additional regulatory action."
Woodcock also announced that the FDA has denied a petition from the consumer advocacy group Public Citizen asking for a phased withdrawal of products containing propoxyphene.
"The reason for the denial is that FDA has determined that propoxyphene is an acceptable option for relief of mild-to-moderate pain when taken as directed," she said. "Moreover, FDA recognizes that other options clinicians might have for pain management come with their own safety concerns."
Propoxyphene-containing products have been linked to fatal overdoses, FDA officials said. Between 1959 and 2005, 91 deaths attributed to an overdose of these products have been recorded in the adverse-events database, said Dr. Gerald Dal Pan, head of the FDA's office of surveillance and epidemiology.
But that database would not necessarily register information on deliberate overdosing, Woodcock said.
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