SILVER SPRING, Md., Nov. 19, 2010 /PRNewswire-USNewswire/ —
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 generic manufacturers of Xanodyne’s decision and they will
be removing their propoxyphene-containing products from the market
as well.

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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.  

“FDA is pleased by Xanodyne’s decision to voluntarily remove its
products from the U.S. market,” said John Jenkins, M.D., director
of the Office of New Drugs in the FDA’s Center for Drug Evaluation
and Research (CDER). “These new heart data significantly alter
propoxyphene’s risk-benefit profile. The drug’s effectiveness in
reducing pain is no longer enough to outweigh the drug’s serious
potential heart risks.”

The FDA is advising health care professionals to stop
prescribing propoxyphene to their patients, and patients who are
currently taking the drug should contact their health care
professional as soon as possible to discuss switching to another
pain management therapy.

Propoxyphene is an opioid used to treat mild to moderate pain.
First approved by the FDA in 1957, propoxyphene is sold by
prescription under various names both alone (e.g., Darvon) or in
combination with acetaminophen (e.g., Darvocet).

Since 1978, the FDA has received two requests to remo

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