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Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

FDA Action on Diet Drug Qsymia – A Summary of this Category X Drug

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After years of not granting approval for any new weight loss medications, the FDA recently approved two new medications: Belviq and Qsymia. Both medications are approved on the understanding that obesity is a life-long condition and these prescription medications are intended to be taken for the rest of a person’s life, in conjunction with diet and exercise. Based on testing in clinical trials, patients who are prescribed the drug should see 3% weightloss for Qsymia or 5% weightloss for Belviq within the first 12 weeks or else treatment should be altered or discontinued.

On August 17, the FDA announced that it had approved the chronic weight management drug Qsymia. Qsymia is a combination of two FDA-approved drugs, phentermine, which is typically used for short-term weight loss for patients on a diet and exercise regimen, and topiramate, a drug used to treat epilepsy and migraine headaches. The new drug, Qsymia, is approved for use in adults with a BMI of 30 or greater or adults with a BMI of 27 or greater and who also have another weight-related health condition.

While the approval of Qsymia may come as good news for the thousands of American who suffer from obesity, it is a drug that present serious pregnancy risks. The FDA specifically warns that Qsymia should not be used during pregnancy as it can cause harm to the fetus, specifically an increased risk of oral cleft birth defects.

The labeling information released by the FDA includes “Fetal Toxicity” in the Warnings and Precautions section of the label, stating that women of child-bearing age should obtain a negative pregnancy test before treatment and monthly thereafter and that women prescribed Qsymia should use effective contraceptive while taking the medication. Women who become pregnant while prescribed the drug should cease treatment immediately. Use of Qsymia while nursing is also not recommended, and either treatment or breastfeeding should be discontinued. One reason that the labeling information indicates for these warnings is the fact that studies have shown that a fetus exposed to topiramate, one of the component drugs of Qsymia, in the first trimester has an increased risk of oral cleft birth defects.

In connection with the significant risks of Qsymia for pregnant women, the “Risk Evaluation and Mitigation Strategy” (REMS) associated with the drug provides that the drug is only available through a limited program, with only certified pharmacies allowed to distribute the drug. This limitation is aimed at ensuring that prescribers and patients know of the increased risk of congenital malformations; the importance of pregnancy prevention for patients taking Qsymia; and the need to discontinue treatment immediately if pregnancy occurs.

Further emphasizing the serious risks to the fetus that Qsymia presents, the drug is packaged with a patient brochure alerting of the risk of birth defects. The release of the drug is accompanied by significant training materials and a certification process that must be met in order for providers to prescribe the drug.

The REMS information is reiterated in the medication guide, which places a special emphasis on the risks of birth defects. Among the “most important information” to know about Qsymia, is that it should never be taken while pregnant.