Xanodyne agrees to withdraw propoxyphene from the U.S. market
Xanodyne Pharmaceuticals Inc. which makes Darvon and Darvocet, the brand version of the
prescription pain medication propoxyphene, has agreed to withdraw the medication from the U.S.
market at the request of the U.S. Food and Drug Administration. The FDA has also informed the
generic manufacturers of propoxyphene-containing products of Xanodyne’s decision and requested
that they voluntarily remove their products as well.
The FDA sought market withdrawal
of propoxyphene after receiving new clinical data showing that the drug puts patients at risk of
potentially serious or even fatal heart rhythm abnormalities. As a result of these data, combined
with other information, including new epidemiological data, the agency concluded that the risks of
the medication outweigh the benefits.
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