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FDA asks AZ to tidy up sales aid

AstraZeneca has received orders in the US from the Food and Drug Administration to stop using a certain sales aid for Seroquel

AstraZeneca (AZ) has received orders in the US from the Food and Drug Administration (FDA) to stop using a certain sales aid for Seroquel as parts of the document are misleading and fail to reveal key information regarding the risks of onset and potential severity of certain side effects, including hyperglycaemia and Type II diabetes mellitus.

In a fax to AZ's director of promotional regulatory affairs in America, the FDA pinpointed several areas where the company's Seroquel sales aid fell short of the required standard, noting that the marketing material `fails to reveal that the risk of developing [tardive dyskinesia] and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered increase'.

The correspondence also pointed out where other vagaries in the notification of potential side effects were unacceptable as they appeared on the professional sales aid, notably that a statement about the clinical manifestation of neuroleptic malignant syndrome (NMS) is misleading. The material states that `A rare condition referred to as neuroleptic malignant syndrome has been reported with this class of medications, including Seroquel'.

However, the FDA deemed this to be misleading in that it `fails to reveal that NMS is a potentially fatal symptom complex associated with the administration of SeroquelÖ furthermore, the professional sales aid fails to convey the important information from the PI regarding the clinical manifestations of NMS and that management of NMS should include immediate discontinuation of antipsychotic drugs'.

Overall, the FDA felt moved to remind AZ that `promotional materials are misleading if they fail to reveal facts that are material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the materials'.

AZ is understood to have taken the FDA's comments ìseriouslyî and is seeking to work with the agency to resolve the matter. The company also made clear that at no point did it intend to disseminate misleading or false promotional material, and that doctors in the US who received the sales aid in question would also have been given a copy of the FDA-approved product labelling for Seroquel, which included the warnings and precautions in full associated with its use in patients.

The FDA has given AZ until November 30, 2006, to make its official written response.

30th September 2008

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