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

Are unborn placed at risk by new diet drug? FDA approves weight-management drug Qsymia

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A new weight-loss drug recently approved by the FDA may seem like potentially good news to those struggling with obesity and weight loss. But, as diet drugs have demonstrated in the past, there is reason to proceed with significant caution. And of particular concern with this latest weight-loss drug approval is the risk of significant birth defects.

Earlier this summer, the FDA has approved the drug Qysmia, formerly marketed as Qnexa. The drug promises dramatic weight loss for individuals who struggle with being over-weight or obese who have a body mass index over 27 or 30. In test trials, patients prescribed the Qysmia were losing 5% to 10% of their weight. The problem is that the prescription drug comes with a major warning: women who are planning a pregnancy or may become pregnant should avoid it.

One reason for this is that Qysmia contains the drug topiramate, generally used as an anti-seizure medication in epilepsy patients. But unfortunately, topiramate has been strongly linked to serious birth defects in children born to women who took the drug during pregnancy. The FDA itself specifically highlighted these risks when it announced it had granted approval for the drug. The Agency warned the “Qysmia must not be used during pregnancy because it can cause harm to a fetus” because of topiramate. Research and data shows that there is an increased risk of oral cleft defects in connection with topiramate. In fact, the drug was initially denied approval in 2010, in part because of the risk of birth defects.

The approval of Qysmia follows the FDA’s approval of another weight loss drug, Belviq, in June. While that drug does not contain topiramate, it also is not supposed to be taken during pregnancy and can also result in serious side effects, particularly when taken in combination with other medicines that address serotonin levels.

Achieving a healthy weight is an important medical issue that much of our population seeks to address. For some, medication may be an important component of an overall treatment plan. But given the potential side effects—particularly for pregnant women—medication simply may be more dangerous than helpful.