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Risk of Birth Defects. 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 prescribers and females of reproductive potential about the:. Healthcare Provider Training Program.
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