2010年10月2日 星期六

Weight Loss | New anti-obesity drug rejected FDA Panel



The troubled path of drug supply continues to look for a challenge, especially after a U.S. Food and Drug Administration (FDA) panel recommended Thursday that the agency to qualify any new anti-obesity drug approval rating in the second of three this year.

The new drug called lorcaserin works, the brain of serotonin, a neurotransmitter in appetite, digestion, memory, mood and other functions involved. Serotonin plays a role in the cardiovascular system and diet drug Fen-Phen (fenfluramine and phentermine) in 1990, after she retired heart valve related problems. When administered in high doses, gave the new drugs many tumors in rats (although there are studies in humans is not associated with increased cancer risk). "In my opinion, the potential risks of the drug outweigh the benefits," Heidi Connolly, a panel member and professor of medicine at the Mayo Clinic, told Bloomberg News.

The other members of the committee, but focuses more on a level of questionable effectiveness as security issues in their final vote of nine to five is against the approval. "I really don 't have many problems with the risks," said Eric Felner, a member of the committee and pediatric endocrinologist at Emory University, told the New York Times. "I thought, I did not look like the work."

FDA requires new diet drug to help people, at least five percent of their weight loss than placebo. Who lost the Lorcaserin weight of about 3.3 percent more than placebo, according to the Times. But the drug has a wider criteria of the FDA at least twice as many people that the drug (compared with placebo) five percent or more met their weight loss.

Qnexa, another diet drug, was approved by the Committee in July. And the record is for the drug-Cont Rave latest assessment of three possible new treatments in December, the Times reported, planned. Although the FDA is not bound to follow the recommendations of the Advisory Committee, often working on their decisions. The company, which Lorcaserin, Arena Pharmaceuticals, FDA approval will continue to pursue, said Arena CEO Jack Lief Bloomberg, and the Agency's decision to come in October.

Many observers are skeptical that pharmaceutical drug supply is a panacea for the growing epidemic of obesity will be released soon, despite the widespread development of obesity and substantial incentives for a blockbuster. Another failure possible for the area: Meridia (Sibutramine) is a product already on the market, could be removed from the shelves in the United States because it is already in Europe. Its use has been to heart attack and stroke by people who are associated with increased risk, and the FDA panel divided (eight to eight) in a vote on 15 September, whether a sale.

Source: iStockphoto / FotografiaBasica

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