WASHINGTON, July 16 (UPI) — A U.S. drug advisory panel turned thumbs down on a new drug to treat obesity because of health concerns, said a panel member.
The advisory committee to the Food and Drug Administration voted 10 to 6 that safety concerns of increased heart rate, possible birth defects and psychiatric problems overshadowed potential benefits of the drug Qnexa, developed by Vivus, The New York Times reported Friday.
The FDA’s handling of new obesity drugs has the drug industry and Wall Street paying close attention, the newspaper said.
Almost two-thirds of American adults are either obese or overweight, so a successful diet drug could garner sales of billions of dollars a year.
But safety concerns remain paramount for the FDA, as weight-loss drugs, likely to be used by millions of people for long periods of time, have a record of health risk problems.
“No one wants to conduct a large public health experiment on the population,” one committee member, Elaine H. Morrato of the University of Colorado, Denver, said.
Vivus chief Leland F. Wilson said the company was disappointed with the vote but would continue trying to win approval.
“The advisory committee vote is a recommendation, not a final step,” he said.
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