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Physicians Who Treat Obesity Question FDA Rejection of Contrave
Date:2/8/2011

ictory that the FDA advisory panel recently recommended lowering the BMI requirement for lap-band surgery without asking for further long-term outcome studies.  Meanwhile, the FDA rejected Contrave and requested the company conduct a study of sufficient size and duration to address the risk of heart attack and stroke. Unfortunately, such studies will likely be costly and require several years to complete, which means that significant time will pass before this drug comes up for approval again.  

The ASBP expects the FDA to consider the demonstrated effectiveness and benefits of weight-loss drugs even if those drugs may carry increased hypothetical risk, because a reduction in obesity leads to a multitude of beneficial effects, which far outweigh minor risks.  

About the ASBP

Founded in 1950, the ASBP is the oldest medical association focused on the education and training of medical professionals treating and managing obese patients and associated diseases. The ASBP is a collaborative organization that provides its members practical information and business tools to implement a successful medical bariatric practice. For more information about the ASBP, visit www.asbp.org.


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