FDA pulls pain med off the market due to safety risks

2010-11-20 00:36:35 GMT+7 (ICT)

WASHINGTON, D.C. (BNO NEWS) -- The U.S. Food and Drug Administration (FDA) on Friday said Xanodyne Pharmaceuticals Inc. which makes Darvon and Darvocet, has agreed to withdraw the medication from the U.S. market due to safety risks.

Darvon and Darvocet is the brand version of the prescription pain medication propoxyphene.

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 agency said it received new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities, and combined with other information, including new epidemiological data, the FDA concluded that the risks of the medication outweigh the benefits.

Propoxyphene is an opioid used to treat mild to moderate pain. First approved by the FDA in 1957, propoxophene is sold by prescription under various names both alone or in combination with acetaminophen.

Since 1978, the FDA has received two requests to remove propoxyphene from the market. Until now, the FDA had concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks of the drug.

-- © BNO News All rights reserved 2010-11-20

Interesting, that's going to change practice a bit but it is nothing insurmountable.