UPDATE: FDA Warns Bayer, Eli Lilly For Misleading Drug Ads
January 12 2010 - 6:52PM
Dow Jones News
The U.S. Food and Drug Administration has warned several
pharmaceutical companies, including Eli Lilly & Co. (LLY) and
Bayer AG (BAYRY, BAYN.XE), for either overstating the effectiveness
of their medicines or not mentioning risks associated with them in
promotional material, according to letters posted to the agency's
Web site Tuesday.
The letters were sent to the companies from December 2009
through Jan. 7 of this year and say promotional material from
Amylin Pharmaceuticals Inc.'s (AMLN), Cephalon Inc. (CEPH), Eli
Lilly and Bayer is misleading. The FDA wants the companies to stop
disseminating the misleading material.
The FDA said representatives of Amylin Pharmaceuticals and Eli
Lilly exaggerated the diabetes-drug Byetta's ability to help
patients lose weight. The companies co-market the product.
The agency said a print advertisement for Eli Lilly's
depression-drug Cymbalta "fails to communicate any risk information
in the main part of the ad." Cymbalta is associated with numerous
risks, including that it may cause patients to contemplate
suicide.
The agency reviewed a script for a live program for Bayer's
birth-control medicine Mirena and said it doesn't adequately convey
that if a woman becomes pregnant while on the medicine she may lose
her baby. Bayer had discontinued using the promotional material in
February 2009 and will respond to the FDA, a company spokeswoman
said.
The agency said a pocket dosing card for Cephalon's
non-Hodgkin's lymphoma treatment, Treanda, includes an "extremely
limited risk presentation." Treanda may cause fatal allergic
reactions or pneumonia.
"Importantly, this presentation omits critical details about the
risks it discloses, including the context that some of these risks
are frequent, severe and potentially fatal," the agency said in its
letter to the company.
- By Jared A. Favole, Dow Jones Newswires; 202-862-9207;
jared.favole@dowjones.com
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