on november 16th the FDA faxed a letter to AstraZeneca in regards to the company’s misleading sales material on their very popular drug, seroquel. the fda requested that AstraZeneca stop disseminating the material, adding that failure to correct the violations discussed may result in fda regulatory action, including seizure or injunction, without further notice. you can visit their website here and download the letter.
after reviewing a recent professional sales aid for seroquel the FDA found that the piece is false and misleading because it minimizes the risk of hyperglycemia and diabetes mellitus and fails to communicate important information regarding neuroleptic malignant syndrome, tardive dyskinesia, and the bolded cataracts precaution.
seroquel is obviously frequently prescribed by our doctors with global sales reaching $2.8 billion last year. who knows what kind of sales we’ll see this year after the FDA’s approval of seroquel for treatment of bipolar last month.
today the company said, “AstraZeneca takes FDA’s letter seriously. we will work with the FDA to resolve the matter.”
yes, they should take the letter seriously. and i hope our doctors would do the same. i was prescribed seroquel twice, by two different psychiatrists, for treatment of depression and then later bipolar. on both occasions the drug was prescribed after the docs reviewed my medical history and found my maternal grandmother died from complications of diabetes and my father is diabetic. a third doctor wanted to prescribe the drug and i put my foot down, i questioned her knowledge of the diabetes risk linked to seroquel. she backed down but i would bet money (and a lot of it) that she continues to prescribe the drug to many unknowing patients.