FDA Requires REMS for New Weight-management Drug

Plan Includes Prescriber Training, Patient Education

September 19, 2012 01:40 pm Matt Brown

Mountain View, Calif.-based pharmaceutical manufacturer VIVUS has launched a risk evaluation and mitigation strategy (REMS) for its newly released weight-management drug Qsymia(ir.vivus.com), which received FDA approval in July.

Qsymia is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with a body mass index (BMI) of 30 kg/m2 or more or a BMI of 27 kg/m2 or more in the presence of at least one weight-related comorbidity, such as hypertension, type 2 diabetes or dyslipidemia.

Although Qsymia is a schedule IV drug, it contains the teratogenic substance topiramate, which has been associated with orofacial clefts in infants exposed to the drug during the first trimester of pregnancy.

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That risk of teratogenicity prompted the FDA to require a REMS for the drug that highlights the importance of pregnancy prevention for females of reproductive potential who receive the drug. The REMS includes a medication guide for patients, a training program for health care professionals, a patient brochure on risks associated with use of the drug and other education tools.

According to a company spokeswoman, VIVUS sent an email about the Qsymia REMS to approximately 90,000 physicians on Sept. 5 and mailed a hard copy of the letter(www.qsymiarems.com) to an additional 30,000 doctors the same day. All of the physicians were "current writers of obesity agents -- specifically, anyone who wrote at least one prescription in the past 12 months," she said.

Qsymia is available only via certified mail-order pharmacies that are part of a home delivery network(www.qsymiarems.com) set up by the company.