In other action, a 50-year-old painkiller linked to deadly
overdoses needs tougher warnings and more research, U.S. regulators
said, rejecting calls from advisers and a consumer group to pull the
product from the market. Propoxyphene-containing products, sold as
Darvon, Darvocet or in generic form, must add a boxed warning about the
risk of excess use, the FDA's strictest caution. The agency also
ordered closely held Xanodyne Pharmaceuticals Inc. (Newport KY) and
generic makers of the drugs to study their effects on the heart at
higher-than recommended doses. Public Citizen, a Washington consumer
group, prompted the FDA to re-evaluate the safety of Darvon in a 2006
petition that cited more than 2,000 accidental deaths linked to the
drug. Outside advisers to the FDA voted 14-12 in January that
Darvon's risks outweighed its benefits. The agency disagreed,
saying most overdoses are intentional and patients should have access to
it.
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