Last week the FDA order Eli Lilly and Co. to stop disseminating advertising material for the popular antidepressant Cymbalta, they characterized as misleading. The FDA posted the letter sent to Lilly on their website last Tuesday claiming that the advertising mailer for Cymbalta overstates the effectiveness of the drug and fails to point out the serious potential dangers associated with the drug. Cymbalta is a powerful antidepressant that has also been used to treat other ailments like diabetic nerve pain and general and anxiety disorder.
The mailer promotes the drug’s use for diabetic nerve pain and states that those patients experienced “significantly less pain interference with overall functioning” when using the drug. The FDA letter noted that this “has not been demonstrated by substantial evidence or … clinical experience.”
The FDA also says that the promotion material fails to disclose important precautionary information about liver toxicity and other serious concerns. In the past there has been a link between Cymbalta, along with other antidepressant like Zoloft and Paxil, and an increased risk of suicide in both children and adults. Although the drug is not approved for use in children, through off-label prescription many doctors have prescribed Cymbalta to treat childhood depression.
Eli Lilly and Co. says that they are working with FDA to resolve this issue and will take the necessary action to reach a satisfactory solution.
For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.