Complaints filed to the FDA specifically related to marketing and advertising date back to 2012, when the agency received a strongly-worded letter from BlueCross BlueShield of Arizona. "We would like to confidentially express concern about the marketing and 'educational efforts' by representatives/employees of Avanir Pharmaceuticals, Inc.," the insurance provider said in its letter. The insurer raised questions about whether PBA occurs in dementia patients and expressed concern that the drugmaker was misrepresenting Nuedexta as safe and effective in populations where it had not been adequately studied. "We believe that the manufacturer appears to be marketing Nuedexta far beyond the scope of the clinical evidence," the company stated in the letter. BlueCross BlueShield of Arizona said in a statement to CNN that it felt compelled to detail these issues for the FDA. "As with any concern where member health and medical guidelines could potentially be compromised, it's our responsibility to act," it said.