FDA issues warning letters to drug companies for misleading ads

ROCKVILLE, Md. Four drug companies have received warnings from the Food and Drug Administration in the last month for what the agency calls misleading direct-to-consumer advertisements and WebMD Blue Book messages, according to letters the FDA released Tuesday.

The companies include Eli Lilly & Co., for the fibromyalgia drug Cymbalta (duloxetine hydrochloride); Amylin Pharmaceuticals, for the diabetes drug Byetta (exenatide); Cephalon, for the leukemia drug Treanda (bendamustine hydrochloride); and Bayer HealthCare Pharmaceuticals, for the contraceptive Mirena (levonorgestrel).

The FDA alleged that the ads omitted and minimized the drugs’ risks, overstated their efficacy, made false and misleading statements and promoted use of the drugs for unapproved indications.

According to the letter to Cephalon, a dosing card for Treanda omitted details about the safety risks of taking the drug, including that some side effects may be fatal. In the case of Byetta, developed by Amylin and Lilly, a Lilly representative allegedly told an FDA official at the annual meeting of the Endocrine Society that though Byetta was approved only as an add-on therapy for diabetes, it could be used alone and that there were “ways to deal with” issues that might arise with managed care – such as Medicare and Medicaid – when prescribing Byetta alone.

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