Blacknbengal
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FDA panel backs weight loss drug Qnexa
SILVER SPRING, Md. — A panel of advisers to the Food and Drug Administration overwhelmingly backed approval for a highly anticipated anti-obesity pill called Qnexa, a drug which the FDA previously rejected due to safety concerns.
The FDA panel of outside physicians voted 20-2 Wednesday in favor of the weight loss drug from Vivus Inc., setting the stage for a potential comeback for a drug that has been plagued by safety questions since it was first submitted to the agency in 2010.
A majority of panelists ultimately backed the drug due to its impressive weight loss results, with most patients losing nearly 10 percent of their overall weight after a year on the drug. But the group stressed that the drugmaker must be required to conduct a large, follow-up study of the pill's effects on the heart. Studies of Qnexa show it raises heart rate and causes heart palpitations, a longtime concern with diet pills over the years. The group of experts said it is still unclear if those side effects lead to heart attack and more serious cardiovascular problems.
http://www.msnbc.msn.com/id/46487890/?ocid=ansmsnbc11#.T0e4iORdCU4
SILVER SPRING, Md. — A panel of advisers to the Food and Drug Administration overwhelmingly backed approval for a highly anticipated anti-obesity pill called Qnexa, a drug which the FDA previously rejected due to safety concerns.
The FDA panel of outside physicians voted 20-2 Wednesday in favor of the weight loss drug from Vivus Inc., setting the stage for a potential comeback for a drug that has been plagued by safety questions since it was first submitted to the agency in 2010.
A majority of panelists ultimately backed the drug due to its impressive weight loss results, with most patients losing nearly 10 percent of their overall weight after a year on the drug. But the group stressed that the drugmaker must be required to conduct a large, follow-up study of the pill's effects on the heart. Studies of Qnexa show it raises heart rate and causes heart palpitations, a longtime concern with diet pills over the years. The group of experts said it is still unclear if those side effects lead to heart attack and more serious cardiovascular problems.
http://www.msnbc.msn.com/id/46487890/?ocid=ansmsnbc11#.T0e4iORdCU4