A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associate 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 prescribers and females of reproductive potential about the:
- Increased risk of congenital malformation, specifically orofacial clefts, in infants exposed to Qsymia during the first trimester of pregnancy
- Importance of pregnancy prevention for females of reproductive potential receiving Qsymia®
- Need to discontinue Qsymia® immediately if pregnancy occurs
For more information about the Qsymia® REMS and education, please visit www.QsymiaREMS.com.