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Sunday, July 1, 2012

Watchdog group warns of heart valve risk related to diet pill.

Reuters (6/26, Kelly) reports that as regulators prepare to rule on whether to approve Arena Pharmaceuticals' diet pill lorcaserin on Wednesday, watchdog group Public Citizen has asked the US Food and Drug Administration to reject the experimental drug, citing concerns that it could pose a risk to heart valves. The group noted that doctors at an FDA advisory meeting last month said evidence from clinical trials showed an increased heart valve disease risk in patients who used lorcaserin. The panel still voted to recommend the drug for approval by a vote of 18 to 4.
        U-T San Diego (6/27) reports the FDA "could delay its decision and require Arena to file more information about Lorcaserin, which could become the first new weight loss drug of its kind approved in the US in more than a decade. The agency is expected to review a possible competing drug -- Vivus' Anexa, on July 17."

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