Zeneca Seroquel

Executive Summary

A fact sheet, slide presentation and videotape that "minimize the potential of Seroquel to cause ocular changes" are among promotions that drew a letter from FDA's ad division May 6. The materials were submitted to FDA following the agency's request in a Nov. 24, 1998, warning letter to review all promotional materials Zeneca continues to distribute. FDA specifically objects to comparisons of Seroquel (quetiapine) and haloperidol and materials emphasizing the use of direct ophthalmoscopy to detect cataract formation. "Direct ophthalmoscopy is not a sensitive measure of lenticular changes and may miss a developing cataract," FDA states. Other violative promotions include a Zeneca brochure implying that the drug is effective for bipolar disorder and schizoaffective disorder. Seroquel is indicated for treatment of manifestations of psychotic disorders in schizophrenic inpatients