On Thursday October 28, 2010, 9:04 pm WASHINGTON (AP) -- Drugmaker Vivus Inc. says federal health regulators declined to approve its experimental diet pill Qnexa, which some doctors and investors have touted as a potential blockbuster weight loss medication.
Vivus said the Food and Drug Administration decided the drug cannot be approved in its present form and asked for more study results and more information on possible risks.
Studies of Qnexa showed patients lost more than 10 percent of their body weight, more than any previous pharmaceutical therapy. But the drug was also associated with side effects including suicidal thoughts and heart palpitations. A panel of FDA advisers voted 10-6 against the drug at a meeting in July.
Weight loss drugs are seen as potential blockbuster sellers, but the drugs have long been plagued by safety issues.
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