Consumer group urges FDA to reject Arena diet drug

Quoted from http://www.reuters.com/article/2012/06/26/us-arena-publiccitizen-idUSBRE85P1D220120626

Consumer group urges FDA to reject Arena diet drug

 

By Susan Kelly

Tue Jun 26, 2012 5:48pm EDT

(Reuters) - Watchdog group Public Citizen urged U.S. regulators on Tuesday not to approve Arena Pharmaceuticals Inc's experimental diet pill lorcaserin, citing concerns it could increase patients' risk of heart valve damage. 

The U.S. Food and Drug Administration is expected to rule on whether to approve the drug by Wednesday.

Public Citizen, a nonprofit consumer advocacy group, said physicians at last month's FDA advisory panel meeting on lorcaserin raised serious concerns about evidence of increased valve disease risks in patients who used the drug in clinical trials. The panel of independent experts voted 18 to 4 to recommend approval of the pill despite the concerns. 

If approved, lorcaserin would become the first new diet drug on the U.S. market in more than a decade.

Heart valve problems were among the issues that led FDA to pull the anti-obesity drug known as fen-phen from the market in 1997, Public Citizen said.

[Article continues at original source]