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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