ADHD Drugs May Get Mania/Psychosis Warning

March 2006

Following last month’s recommendation to add a “black box” warning about cardiovascular risks, attention deficit hyperactivity disorder (ADHD) drugs may also have to provide information about the possible risk of psychosis or mania.

Since January 2000, the Food and Drug Administration (FDA) and drugmakers have received hundreds of reports of psychosis or mania behavior in patients taking the drugs. Most of the reported cases were children 10 or younger. At this age, hallucinations are uncommon. After patients stopped taking the ADHD drug, their symptoms stopped.

From 2000 to 2005, the use of ADHD drugs rose 57% in children and adolescents and doubled in adults. Currently, ADHD drug labeling does not clearly state the risk of mania or psychosis symptoms in patients.

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