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dapagliflozin (FARXIGA, QTERN, XIGDUO XR)

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    Public Citizen calls on the Food and Drug Administration’s (FDA’s) Office of Prescription Drug Promotion to halt the dissemination of direct-to-consumer advertisements for five prescription drugs approved only for the treatment of Type 2 diabetes. The ads promote the drugs for the off-label uses of weight loss and blood pressure reduction. Public Citizen also calls on the agency to fine the companies responsible for issuing the ads, an action that it has never before taken in response to such violative ads.
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    Public Citizen urges the agency not to approve dapagliflozin, a member of a new chemical class of drugs to treat type 2 diabetes mellitus, because it is no more effective than a similar diabetes drug, canagliflozin, approved by the FDA in March 2013, but does appear to pose additional safety hazards not seen with canagliflozin, including risks of bladder cancer and liver toxicity.

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