FDA Warns Baxter International Over Promotional Material For Tisseel

Promotional material for Baxter International Inc.'s (BAX) surgical sealant Tisseel overstates the product's effectiveness and is false and misleading, according to the U.S. Food and Drug Administration.

Presentations and brochures for Tisseel, a type of surgical tissue used to control bleeding, makes claims about the product that aren't supported by evidence, according to a letter posted Tuesday on the FDA's Web site. The letter was sent to Baxter on April 14.

A Baxter representative wasn't immediately available to comment.

The FDA said the promotional material claims Tisseel is "97.5% effective in achieving hemostasis" for patients undergoing heart and lung bypass surgery. Hemostasis is the stoppage of bleeding. Tisseel's label notes the product has a demonstrated effectiveness of up to 88.2%.

The FDA said the material also implies Tisseel is effective for more treatments than those for which it has been approved. Tisseel is approved only for patients undergoing heart and lung bypasses, or injuries of the spleen.

The FDA wants Baxter to immediately stop dissemination of the promotional material. The FDA wants the company to respond, detailing how it plans to put truthful, corrective messages out to make sure the audiences that saw the old material get the correct information.

-By Jared A. Favole, Dow Jones Newswires; 202-862-9207; [e-mail]