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Qsymia carries pregnancy risks (topiramate causes birth defects), a more complex side effect profile including cognitive effects from topiramate, and it requires participation in a REMS risk management program

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The FDA emphasized that compounded drugs are not FDA approved and therefore are not reviewed by the agency for safety, effectiveness, or quality before marketing

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Sokos GG, Nikolaidis LA, Mankad SD, Elahi E, Shannon RP

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