Black box warning seroquelS. . The FDA requested that AstraZeneca add a black box warning to the packaging of Seroquel to reflect this risk. Here’s an FDA excerpt:. Food and Drug Administration (FDA) has issued a special warning (a "black box warning") about the use of Seroquel in elderly people with psychosis or dementia (a . . . . . . . . The FDA ordered a black box warning of an increased risk of death in elderly patients with dementia and warning . . . . full list of black box warning... more