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FDA GIVES GREEN LIGHT TO POTENTIALLY DANGEROUS WEIGHT LOSS DRUG

FDA GIVES GREEN LIGHT TO POTENTIALLY DANGEROUS WEIGHT LOSS DRUG

The Food and Drug Administration recently approved the first prescription diet drug in a decade. The drug, Belviq, is made by Arena Pharmaceuticals, which claims that it can help obese dieters lose weight by modifying their brain chemistry to create a sense of fullness.

A rival drug called Qnexa may receive approval in July. Safety concerns caused Qnexa to be rejected by a government advisory panel in a 10-6 vote in 2010, but the drug was approved when it came up for review a second time. Despite the government approval, some consumer advocates worry that Belviq and Qnexa are actually dangerous pharmaceuticals set to repeat the Fen-Phen debacle of the '90s.

Belviq, which is the trade name of Lorcaserin, will be available next year. Several post-marketing studies have yet to be completed, however, including investigations into whether the drug may lead to heart attacks and stroke. The use of the drug in obese children must also be studied.

Some consumer groups are skeptical that the drug will be effective or that the risks of the drug outweigh the benefits, given concerns regarding heart valve disease associated with the drug.

"Its benefits are really small, and practically everyone on the advisory committee agreed that there wasn't enough evidence to rule out clinically significant heart valve disease," said Sidney Wolfe, who directs the health research group of the consumer group Public Citizen. "We've already had a weight reduction drug (Fen-Phen) taken off the market because it damaged heart valves."

Source: USA Today, "FDA OKs first new prescription diet drug in a decade," Nanci Hellmich, June 27, 2012

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