Xanodyne Pharma said that the withdrawal is part of a market-wide withdrawal applying to all propoxyphene-containing products, affecting branded and generic pharmaceutical companies and a number of products on the market.
Propoxyphene is a mild opiate used for the treatment of mild-to-moderate pain.
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 Center for Drug Evaluation and Research (CDER) Office of New Drugs director John Jenkins said that the FDA is pleased by Xanodyne’s decision to voluntarily remove its products from the US market.
"These new heart data significantly alter propoxyphene’s risk-benefit profile," Jenkins said.
"The drug’s effectiveness in reducing pain is no longer enough to outweigh the drug’s serious potential heart risks."
CDER Office of Surveillance and Epidemiology director Gerald Dal Pan said that with the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart.