FDA Requires REMS for New Weight-management Drug

Mountain View, Calif.-based pharmaceutical manufacturer VIVUS has launched a risk evaluation and mitigation strategy (REMS) for its newly released weight-management drug Qsymia, 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.

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 (2-page PDF; About PDFs) 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 set up by the company.