Lilly Busted For Cymbalta Mailer

Yesterday, the FDA sent Eli Lilly, makers of Cymbalta, a letter concerning a mailer the company had sent to doctors touting the drug for diabetic nerve pain treatment, an approved indication for the drug.

From a press account:

"The mailer claimed Cymbalta could help patients 'experience less pain interference with overall functioning.' It used a series of bar charts to show how Cymbalta could ease pain that interferes with walking, sleeping, mood, enjoyment of life and other functions. However, the FDA said that claim 'had not been demonstrated by substantial evidence or substantial clinical experience.'

"In addition, the FDA said the mailer failed to reveal risks for patients with certain conditions, including a form of glaucoma, and did not give precautions about liver toxicity or side effects connected with abrupt discontinuation of the drug.

"'Although the mailer presents numerous efficacy claims, it fails to communicate some of the most serious risks,' the letter said."

A Lilly spokesman told a reporter the company was working to understand the FDA's concerns and would act once it had greater clarity. I'd say the FDA's concerns are pretty clear.