The FDA has asked AstraZeneca to halt distribution of a professional sales aid used to market its antipsychotic medication Seroquel.
In a warning letter sent to AstraZeneca, the FDA’s Division of Drug Marketing, Advertising & Communications (DDMAC) wrote that the sales aid is misleading because it minimizes the risk of side effects associated with Seroquel.
“The promotional material raises significant public health and safety concerns through its minimization of the risks associated with Seroquel,” DDMAC wrote.
AstraZeneca spokesman Jim Minnick told MM&M the company was working closely with the FDA to resolve the matter.
“The purpose of the piece was to convey to healthcare professionals accurate and scientifically substantiated information about the risk of diabetes, accompanied by a copy of the FDA approved product information product labeling,” Minnick said.