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The European Medicines Agency recommended in 2009 that "marketing authorizations for propoxyphene be withdrawn across the European Union.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: Tagging drugs to fight counterfeit medicines

add to favorites email to friend print save as pdf

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

Use new meningitis vaccines only for outbreaks

1 hour ago

(AP)—A U.S. panel on Thursday recommended that two new meningitis vaccines only be used for rare outbreaks, resisting tearful pleas to give it routinely to teens and college students.

New antibiotic avycaz approved

5 hours ago

(HealthDay)—The combination antibiotic Avycaz (ceftazidime-avibactam) has been approved by the U.S. Food and Drug Administration to treat adults with complicated infections of the intra-abdominal area or urinary tract, ...

Tagging drugs to fight counterfeit medicines

Feb 25, 2015

The U.S. and other countries are enacting rules to clamp down on the sales of fake pharmaceuticals, which pose a public health threat. But figuring out a system to track and authenticate legitimate drugs still faces significant ...

Watchdog group seeks FDA ban of antifungal tablets

Feb 24, 2015

(AP)—A consumer safety group is calling on the Food and Drug Administration to pull certain antifungal tablets off the market, saying there are safer medicines that do not carry risks of liver damage.

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.