That’s what the FDA had to say about a mailer concerning the Cymbalta antidepressant that Lilly sent to docs, according to a warning letter. The agency called the promotional material “false or misleading in that it overstates the efficacy of Cymbalta and omits some of the most serious and important risk information associated with its use.” (The mailer is right here).

Here are a few excerpts: “These claims and presentations are false or misleading because they overstate the efficacy of Cymbalta by suggesting that patients with diabetic peripheral neuropathy who are treated with the drug experience significantly less pain interference with overall functioning, when this has not been demonstrated by substantial evidence or substantial clinical experience…Moreover, the studies at issue were not adequately designed to substantiate the claim of ’significantly less pain interference with overall functioning.’ ”

Then there’s this: The mailer fails to reveal the contraindication regarding use in patients with uncontrolled narrow-angle glaucoma and the
contraindication and bolded warning relating to use with monoamine oxidase inhibitors (see background section). Furthermore, the mailer fails to reveal the Precautions relating to hepatotoxicity, abrupt discontinuation of Cymbalta treatment, and use of the drug in patients with concomitant illness.”