Drugmaker pulls painkillers from US market over heart risks

Nov 19, 2010

Drugmaker Xanodyne Pharmaceuticals Inc. agreed Friday to pull two of its painkillers, Darvon and Darvocet, from the US market over heart risk concerns, the US Food and Drug Administration said.

Similar withdrawals from the market of the drug also known as propoxyphene were recommended in Europe in 2009 and are already under way.

"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 ," the agency said.

"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."

Generic manufacturers of the medication were also notified of Xanodyne's decision and urged to do the same, the FDA said.

The European Medicines Agency recommended in 2009 that "marketing authorizations for propoxyphene be withdrawn across the European Union. A phased withdrawal of propoxyphene is underway," the FDA noted.

Propoxyphene, an opioid used to treat mild to moderate pain, has been on the US market since it was first approved by the FDA in 1957.

Explore further: Teva to lift bid for Mylan: report

Related Stories

FDA orders overdose warnings for Darvocet

Jul 07, 2009

(AP) -- The government is letting the painkillers Darvocet, Darvon and their generic cousins stay on the market but ordered stronger warnings against deadly overdoses on Tuesday.

FDA relents from midodrine withdrawal plan

Sep 06, 2010

(AP) -- Federal regulators have backed off a plan to remove a Shire PLC low blood-pressure treatment from the market after warning in August that the drug has not been proven effective.

FDA rejects new obesity drug Qnexa

Oct 30, 2010

The US Food and Drug Administration has rejected a marketing request by Vivus for its new obesity treatment called Qnexa, because it considers it a health risk, the California-based biotech firm said in a statement.

FDA cracks down on hydrocone products

Sep 29, 2007

The U.S. Food and Drug Administration says it will start taking enforcement action against companies marketing unapproved hydrocodone products.

Recommended for you

Teva to lift bid for Mylan: report

8 hours ago

Israeli pharmaceutical giant Teva plans to increase its bid for rival Mylan and could announce the move as soon as this week, according to a US media report Monday.

Vaccine for West Nile Virus enters human clinical trials

13 hours ago

A clinical trial of a new investigational vaccine designed to protect against West Nile Virus infection will be sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes ...

FDA clears drug for leading form of cystic fibrosis

Jul 02, 2015

Federal health officials have approved a new combination drug for the most common form of cystic fibrosis, the debilitating inherited disease that causes internal mucus buildup, lung infections and early death. But it will ...

User comments : 1

Adjust slider to filter visible comments by rank

Display comments: newest first

Chace_Schutte
5 / 5 (1) Nov 19, 2010
I'm so happy I read this 15 mins after it was published, My doc prescribed me these and I have been reluctant to take any kind of pills because I prefer vaporizing marijuana. I have taken them but I'm not going to anymore : P THANK YOU PHYSORG!

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.