A medication that would be the nation’s first new prescription diet drug in a decade may be nearing approval by the Food and Drug Administration.
An FDA advisory committee, in a 13-to-7 vote, has recommended approval of Contrave, a diet drug from Orexigen Therapeutics of San Diego.
The panel, Reuters reports, found that the benefits of the drug outweighed its risks, despite concerns that the drug caused a slight increase in blood pressure and pulse rate while having only a modest effect on weight loss. However, at least 35 percent of patients in the drug trials lost at least 5 percent of their weight.
Some panelists worried that rejection of yet another diet drug — two have been turned down by the FDA this year — could discourage development of needed diet aids even as two out of three Americans are overweight or obese. Weight-related problems are “the most serious disease that the United States is facing,” said the panel’s chairman, Abraham Thomas, head of endocrinology at Henry Ford Hospital in Detroit.
Contrave acts by both boosting metabolism and curbing appetite and cravings.
The higher blood pressure and pulse rate caused by Contrave could potentially increase the risk of heart attacks and strokes, but the trials conducted by Orexigen were too limited to determine that. The FDA and the company agreed that a larger trial to examine the risk of heart attacks should be conducted, and the advisory panel voted 11 to 8, with one abstention, that that study could be done after the drug was approved by the FDA, according to the New York Times.
The FDA usually follows the recommendations of its advisory panels. A final ruling is due by Jan. 31, but there could be a delay while the details of the follow-up trials that would be conducted after the drug is approved are being decided.
Reuters noted that drug companies seeking to sell diet pills have been thwarted for decades by serious side effects. Xenical, approved in 1999, remains an approved prescription weight-loss drug, as does a lower-dose, over-the-counter version called Alli. Both can cause serious liver problems, uncontrolled bowel movements and gas.
Meridia, which was on the market since 1997, was withdrawn in October due to heart risks.
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Once you have decided that you want to diet, you need to pick a diet plan that you can stick to. One of the best types of plans that you can choose is one that relates to your weight loss goals. In order to determine your weight loss goals, you need to look at how much weight you want to lose. Are you trying to get rid of ten pounds or fifty? The more aggressive you want to diet, the more strict of a diet plan you will end up needing. Sometimes, a planned diet may just not work, know your limits, or you may regret beginning to diet at all.