The U.S. Food and Drug Administration has sent a warning letter to drug maker AstraZeneca, claiming that some of the company’s promotional material for Seroquel contains “false or misleading†information. According to the FDA, AstraZeneca failed to adequately detail the risks of hyperglycemia and diabetes and omitted important data about neuroleptic malignant syndrome and other relevant conditions. Seroquel, an atypical antipsychotic that is used in the treatment of bipolar disorder and schizophrenia, earned roughly $2.76 billion in worldwide sales in 2005.
The FDA sent its warning letter on November 16 to James Gaskill, AstraZeneca’s director of promotional regulatory affairs. The letter held the company in violation of the Federal Food, Drug, and Cosmetic Act because of a misleading promotional sales aid for Seroquel. The promotional material does not include significant data from the product’s required patient-information labeling. According to the FDA’s letter, “The promotional material raises significant public health and safety concerns through its minimization of the risks associated with Seroquel.â€
The FDA is asking AstraZeneca to refrain from circulating the misleading materials. The company has until the end of the month to respond to the warning letter, but has announced its intentions to work with the FDA to resolve the matter.
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