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FDA Advisory Committee Rulings on Obesity Drugs Not Favorable

>> Saturday, September 18, 2010



The FDA has been busy this week, with meetings to discuss the future of two obesity drugs, one of which is currently available, and one of which is in the pre-approval phase. Overall, the future for both looks bleak.

Sibutramine (Meridia) is an obesity drug that works as an appetite suppressant, and has been available in Canada for a decade. It has come under scrunity in the past year following the results of the SCOUT trial, which was a study examining the effects of sibutramine vs placebo in over 10,000 participants who had preexisting heart disease, diabetes, or both. This study, which was published in the New England Journal of Medicine a couple of weeks ago, showed that there was a 16% increase in risk of heart attack and stroke. The increased risk was seen only in patients with known cardiovascular disease; patients with diabetes but no known history of heart disease did not have an increased risk of these events.

In response to these data, which were made available earlier this year, sibutramine was pulled from the market in Europe, but it has remained available in North America. An FDA Advisory Meeting held this week (with Alberta's own Dr Arya Sharma being one of the presenters to the committee) resulted in a 50/50 vote as to whether to recommend that the drug be pulled from the American market. Eight members voted that the drug be removed from the market, while the other 8 voted that it remain on the market with new labelling restrictions.

The following day, the FDA held another advisory meeting, this time to discuss a new obesity medication called lorcaserin. The panel voted 9 to 5 against its approval for use in USA, stating that the modest weight loss seen did not make up for several unanswered questions about its safety.

Thus, the struggle to find effective and safe weight loss medications is still underway. A newer class of injectable medication used to treat type 2 diabetes, called GLP-1 analogs, assist with weight reduction, and are currently in trials for weight loss (though not yet approved for this purpose) in non-diabetics. In September 2010, these seem to be the brightest spot on the horizon.


Dr. Sue Pedersen © 2010 www.drsue.ca drsuetalks@gmail.com


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1 comments:

liposculpture guide January 27, 2011 at 2:18 AM  

Obesity affects approximately 300 million people globally and 60 million people in the U.S. The condition is responsible for approximately 112,000 deaths in the U.S. annually.the FDA is in a tough position, facing criticism on its safety record at the same time it is being pressured to approve drugs faster.

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