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Diet Drug Faces Scrutiny Over Side Effects
Vivus Inc. is going to face questions later this week about side effects of its experimental diet drug Qnexa.
Food and Drug Administration staffers are raising concerns in a report about anxiety, depression and irregular heartbeat. They also note that there’s still an unanswered question about the effects on pregnant women who take Qnexa.
Vivus, a money-losing biotech company from California, faces a panel of government experts Thursday who will make recommendations on the drug. Vivus is the first of three companies seeking U.S. approval of new diet drugs this year. Arena Pharmaceuticals Inc. and Orexigen Therapeutics Inc. also hope to get U.S. clearance to sell their products.
Despite the concerns, investors viewed the FDA report on Qnexa as generally positive because it also noted the pill is effective. The company's shares shot up 16 percent.
“Vivus is looking forward to addressing the FDA's questions at this Thursday's advisory committee meeting,” a company spokesman says.
Brett Chase covers health care for Portfolio.com and writes the blog Heavy Doses.
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