US FDA warns Japan's Daiichi over drug promotions
Source: Reuters
(Adds company comment paragraph 5) WASHINGTON, Jan 19 (Reuters) - The U.S. Food and Drug Administration has warned Daiichi Sankyo Co Ltd. <4568.T> about misleading promotional materials for its dry mouth drug Evoxac, according to an agency letter released on Friday. Daiichi Sankyo, Japan's second-largest drugmaker, distributed wall calendars and dry erase boards that promoted how well the drug worked without also disclosing the risks it carried, the FDA said. Evoxac, also known as cevimeline, is approved in the United States to treat dry mouth in patients with Sjogren's Syndrome -- a disease in which the body's immune system targets glands that produce moisture. In its letter, the FDA requested that Daiichi immediately cease disseminating the items and respond to the agency's warning by Jan. 29. Daiichi Sankyo spokesman Greg Barrett, in a statement, said the company had received the letter and would respond to the FDA as required. He did not specifically address the agency's concerns about the promotional materials. The agency said information about Evoxac's side effects, which include possible heart and breathing complications, among others, were listed on the back of the calendars and boards but "as a practical matter, this information is not visible or even accessible to the viewer" because adhesive backing and other coverings obscured it." "As a result, the pieces misleadingly suggest that Evoxac is safer than has been demonstrated by substantial evidence," the letter said. The FDA posted the warning on its Web site at http://www.fda.gov/cder/warn/2007/Evoxac-wl.pdf. Dozens of FDA warning letters are issued each year but are usually resolved without incident, although the agency can impose fines and other penalties.
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