FDA Criticizes Cymbalta's Medical Journal AdsNov 10, 2005 | Bloomberg
Eli Lilly & Co. failed to make the risks of its Cymbalta medicine clear enough in medical journal advertisements that promoted the drug to treat nerve pain caused by diabetes, U.S. regulators said.
In a letter to Lilly posted Wednesday on the U.S. Food and Drug Administration Web site, the agency said the company should stop running the ads. David Shaffer, a Lilly spokesman, said Wednesday in a telephone interview that the ads appeared in the 2004 fourth quarter and the 2005 first quarter and won't be run again.
The FDA said the ads are considered Cymbalta promotion even though their main panels don't mention the drug. Cymbalta, also used as an antidepressant, has risks that include dementia if used with older antidepressants known as monoamine oxidase inhibitors. It also can spur allergic reactions, the FDA said.