Obesity has reached epidemic proportions in America and across the globe. But until now, anti-obesity drugs have been fraught with problems and complications. There has not been an anti-obesity drug since 1999 that successfully entered the US Market. Qsymia, a new combination pill of phentermine and topiramate , has been approved. Phentermine is an appetite suppressant used for a limited period of time to speed weight loss. Topiramate is a well known anticonvulsant that has weight loss side effects when combined with Phentermine. The drug is approved for use in adults with a body-mass index (BMI) in the obese range (>30 kg/m2 ) or with a BMI of >27 kg/m2 if the individual has at least one weight-related condition (i.e. hypertension, type 2 diabetes, or dyslipidemia.)
Importantly, Qsymia could increase heart rate, and should be used with caution for people with unstable heart disease or stroke, according to the FDA. Both the FDA and its advisory committee decided against approval of Qsymia during its first round of consideration in October 2010, pending a more comprehensive safety assessment.
Its approval is accompanied by the promise of the drug maker to employ what is known as risk evaluation and mitigation strategy (REMS). The purpose of REMS is to provide drug safety information to the public to improve transparency and communication. The manufacturer is required to circulate information to be sure that patients are aware of both the benefits and risks of drugs. The drug “will only be dispensed through specially certified pharmacies,” according to the FDA statement. Of special note, the drug must not be used during pregnancy.
Will the drugs help or hinder the obesity epidemic?
@dmontgomerymd I think diet & exercise are the best ways to lose weight. These “quick fix” pills & surgeries are dangerous.
— Joy Haye (@joy_poetic) August 17, 2012
Rhonda Lee is associate web editor for DMMDhealth.