Qsymia risk management system used to to prevent fetal harm

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Qsymia is an FDA approved drug used to manage weight in obese and some overweight adults who may have weight-related medical problems such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia). The drug is intended to be used in combination with a healthy diet and exercise.

However a Risk Evaluation and Mitigation Strategy (REMS) is used for the drug because of the effects that Qsymia can have on fetuses. The purpose of the Qysmia REMS is to ensure that prescribers and females using the drug are aware of and take appropriate actions to prevent such effects.

Possible risks include congenital malformation, especially orofacial clefts (cleft palate and lip, for example) in the first trimester of pregnancy. Because of these risks women who want to use Qsymia must explicitly prevent pregnancy, and discontinue Qsymia immediately if pregnancy occurs.

The strategy is similar to that used for the drug Isotretinoin (marketed as Accutane), which is used to treat severe nodular acne. Isotretinoin REMS requires women using the drug to agree in writing to using two forms of birth control, and have regular pregnancy tests before, during and after taking the drug.

Dr. Ross notes The possible teratogenic effects of Qsymia must be widely disseminated to all physicians who might prescribe the drug for weight loss. And they must make every effort to ensure their female patients take appropriate actions to either prevent pregnancy while using Qsymia, or stop using it if they do become pregnant.