[Valid Atom 1.0]

sexta-feira, 16 de julho de 2010

FDA panel votes down new obesity drug

The headquarters of the U.S. Food and Drug Administration (FDA) is seen in Silver Spring, Maryland November 4, 2009. (Xinhua/Reuters File Photo)

BEIJING, July 16 (Xinhuanet) -- Advisory committee of the U.S Food and Drug Administration (FDA) voted against anti-obesity drug Qnexa for safety concerns, media reported Thursday.

The panel cited side effects such as possible birth defects, increased heart rate, and psychiatric problems. It said those risks outweigh the pill's effect of causing weight loss. Ten people out of sixteen on the panel voted no.

Chair of the panel Kenneth Burman said he hoped his veto “will allow more discussion”. “I would not be upset if it were approved with more indications (limiting its use)," the MD of Georgetown University said.

Almost all on the panel agreed that the pill, developed by Vivus Inc., has stronger effect than all approved weight loss drug. However, the drug’s side effects are not to be overlooked.

For example, it may cause birth defects, may increase suicidal tendency, may cause a condition called metabolic acidosis that speeds bone loss; it also poses risk of kidney stones, among other serious effects.

Vivus said in a statement it would continue working with the FDA, despite disappointment that the panel voted down the drug. FDA is scheduled to make a final decision on the drug in October.



๑۩۞۩๑๑۩۞۩๑๑۩۞۩๑๑۩۞۩๑๑۩۞۩๑


LAST

Sphere: Related Content
26/10/2008 free counters