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On Wednesday, a U.S. Food and Drug Administration advisory committee will debate whether the FDA should require attention deficit/hyperactivity disorder drugs to carry an updated label. The new label would warn millions of ADHD drug users of the possible risks of psychosis or mania, particularly with pediatric use.

According to a memo written by two psychiatric drug reviewers in the FDA''s Office of Drug Safety, the agency and drugmakers received hundreds of reports of psychotic and manic behavior, especially hallucinations, in patients who took ADHD medications since January 2000. Additionally, the patients had no previous or known risk factors that may have contributed to the psychosis.

Data from Medco Health Solutions reveals that the use of ADHD medications by children and adolescents in the U.S. increased 57 percent from 2000 through 2005. The use of ADHD drugs in adults doubled between that time.

The psychiatric drug reviewers, Kate Gelperin and Kate Phelan, wrote that the current FDA approved ADHD drug labeling doesn''t give adequate information about the risks of psychosis or mania behavior linked to the drugs. Furthermore, they say the labeling does not clearly state that the use of the medications should be terminated if such symptoms do develop. “We recommend that these issues be addressed,” they write.

Gelperin and Phelan noted that a “substantial proportion” of reported cases of hallucinations occurred in children 10 years of age or younger. “The predominance in young children of hallucinations, both visual and tactile, involving insects, snakes and worms is striking, and deserves further evaluation.” In many of these cases, the psychosis and mania symptoms went away after the patients stopped using the drug, the reviewers write.

Associate professor of psychiatry at Harvard Medical School, Timothy Wilens, says that most physicians are fully aware of the side effects associated with the drugs, including psychosis. “I''m not sure what''s going to be gained by spending a lot more time on this,” Wilens said in an interview on Monday.

Wilens also believes that in many cases of psychosis in ADHD drug users, the medications reveal a previously undiagnosed condition like bipolar disorder.

However, Grace Jackson, psychiatrist and member of the International Center for the Study of Psychiatry and Psychology, says that ADHD drugs “are exactly the same chemicals” as street drugs, which are known to spur psychosis behavior.

The pediatrics advisory panel will also join the new label debate on Wednesday. The FDA is not required to follow the advise of the advisory committees, but usually does.