FDA letters cite Lilly, Bayer, Amylin, Cephalon over misleading promotional materials
The AP (1/13, Perrone) reports that the FDA “issued enforcement letters to Eli Lilly, Bayer, Amylin Pharmaceuticals, and Cephalon for making inaccurate or incomplete statements while promoting their drugs.” The agency’s “letter to Lilly cites a print advertisement for the antidepressant Cymbalta, which is approved to treat depression, generalized anxiety disorder, diabetic nerve pain, and the pain ailment fibromyalgia.” The FDA indicated that Lilly’s ad fails to “adequately display information about the drug’s side effects.” Dow Jones Newswire (1/13, Favole) reports that the FDA said Amylin and Lilly representatives overstated diabetes drug Byetta’s weight loss benefits, and that Bayer’s promotional material for the birth-control drug Mirena does not adequately warn women of the risk of losing their baby if they become pregnant while taking the drug.
Meanwhile, the FDA’s letter to Cephalon said the drugmaker did not include important risk information on a dosing card for its lymphoma treatment Treanda, Reuters (1/13, Heavey) reports. The FDA asked that the drugmakers halt use of the advertisements and promotional materials immediately.