FDA WARNS DAIICHI SANKYO FOR MISLEADING DRUG MARKETING

The FDA warned Daiichi Sankyo for promotional items it said were misleading because they obscured risk information for Evoxac, a drug that treats dry mouth in patients with Sjogren's syndrome.

Daiichi Sankyo made wall calendars and dry erase boards that presented efficacy claims, but hid risk information, the warning letter said. The risk information was printed on the backs of the materials, making it inaccessible to viewers, the agency said. The failure to include risk information on the promotional materials misbrands Evoxac, the letter added.

Opaque paper backings and adhesives cover the backs of the calendars and boards, so the information is completely obscured, according to the FDA. Even if the paper backing is removed, the products are designed to stick to walls or other surfaces, so the risk information would again be hidden, the agency added.

The FDA said even if the risk information on the backs of the materials could be accessed, the products would still be misbranded. The risk information and the effectiveness claims must be in the same place on the marketing materials, according to the letter.

The agency asked Daiichi Sankyo to stop distributing the calendars and dry erase boards, and also to send a corrective message about potential risks with Evoxac to audiences who received the promotional materials.

The warning letter can be viewed at www.fda.gov/cder/warn/2007/Evoxac-wl.pdf (http://www.fda.gov/cder/warn/2007/Evoxac-wl.pdf).