Risk Evaluation and Mitigation Strategy (REMS)

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks. The FDA has required a REMS for Qsymia.

The purpose of the Qsymia REMS is to inform certified pharmacies and patients of reproductive potential about the:

• Increased risk of embryo-fetal toxicity with major congenital malformations, including but not limited to cleft lip and/or cleft palate (oral clefts), and of being small for gestational age (SGA) in a fetus
• Importance of pregnancy prevention for patients of reproductive potential receiving Qsymia
• Need to discontinue Qsymia immediately if pregnancy occurs

Dispensed to Patients Through Certified Pharmacies

Qsymia is available only through certified pharmacies. Click Here to learn more.