DDMAC Cites Watson for Misleading Ferrlecit Promotions
Two journal advertisements circulated by Watson Pharmaceuticals contain misleading information about the firm's anemia treatment Ferrlecit, according to the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC).
DDMAC issued Watson an untitled letter after reviewing a reminder ad and a "non-product specific belly band" ad that appeared in the October 2004 issue of Kidney International. The reminder ad appeared on the back cover of the journal and the belly band was placed around the outside of the issue, according to the warning letter.
Although the ads didn't appear together in the journal, DDMAC said it considers the two pieces to be one full product ad because they shared numerous presentation elements and were placed in close physical proximity to one another. The combined promotional pieces made several claims about Ferrlecit (sodium ferric gloconate), but they omitted specific information about the drug and failed to include any risk information, DDMAC said.
In addition to omitting risk information, the belly band contained the claim "easy administration." DDMAC called the claim "misleading at best," noting that patients require Ferrlecit to be administered intravenously over eight sessions at sequential dialysis treatments.
The FDA asked Watson to immediately cease dissemination of the promotional materials and submit a written response to the untitled letter by May 19.
To view the letter, go to http://www.fda.gov/cder/warn/2005/Ferrlecit_ltr.pdf (http://www.fda.gov/cder/warn/2005/Ferrlecit_ltr.pdf).