FDA Seeks Halt of Cymbalta Promotion

The U.S. Food and Drug Administration (FDA) has determined that a professional mailer on Cymbalta from manufacturer Eli Lilly and Co. is "false and misleading" in that it "overstates the efficacy of Cymbalta and omits some of the most serious and important risk information associated with its use" in violation of federal law. FDA has ordered Lilly to cease dissemination of these promotional materials. Cymbalta has been approved for treatment of major depressive disorder, management of pain associated with diabetes, and treatment of generalized anxiety disorder.

• FDA Letter to Eli Lilly and Co. [PDF file]
• Wall Street Journal: FDA Asks Eli Lilly to Stop Promotion of Cymbalta
• Cymbalta Safety Information (Eli Lilly and Co.)
• Duloxetine (marketed as Cymbalta) Information (FDA)