Medical Marketing and Media - FDA to Lilly: Can Cymbalta journal ads
THE FDA called on Eli Lilly to stop journal ads for Cymbalta as a treatment for nerve pain caused by diabetes because the ads fail to address drug risks.
In a Sept. 9 untitled letter posted by the agency last month, the Division of Drug Marketing, Advertising and Communications (DDMAC) said the ads, which ran through spring of 2005, are considered Cymbalta promotions, even though their main panels don’t mention the drug.
Risks for users of Cymbalta, also used as an antidepressant, include dementia when taken with older antidepressants known as monoamine oxidase inhibitors. In October. Lilly issued a “Dear Doctor” letter warning against the drug’s use in patients with preexisting Ii ver conditions.
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The drug can also spur allergic reactions, DDMAC said. The ads first appeared in the fourth quarter of 2004 and ran through the first quarter of 2005, but were not scheduled to appear again, Lilly execs said. Lilly credited a 5.2% increase in profits for the third quarter in part to strong sales of the SSNRI. - M. A.
Copyright Haymarket Media, Inc. Dec 2005
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