Eli Lilly receives warning about Cymbalta
Pharma Compliance Alert, October 10, 2007
In a warning letter posted last week, the FDA informed Eli Lilly that its professional mailer for Cymbalta was false or misleading because it "overstates the efficacy of Cymbalta and omits some of the most serious and important risk information associated with its use."
Cymbalta is approved to treat major depressive disorder, manage neuropathic pain associated with diabetic peripheral neuropathy (DPN), and treat generalized anxiety disorder. According to the FDA, the mailer recommends Cymbalta for only the second use.
In addition, the FDA claims the mailer is false or misleading because it suggests "patients with DPN 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."
The mailer also fails to list some of the most serious side effects associated with Cymbalta.
The FDA wants Eli Lilly to stop using the mailer, as well as other promotional material that contains the same claims.
Click here to read the warning letter.
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