The review included 49 randomized, controlled clinical trials in the pediatric development programs, as well as postmarketing adverse event reports (AERS). The evidence shows that hallucinations and other psychotic symptoms emerge in children prescribed every one of the ADHD drugs: In controlled trials, only children taking the drugs suffered treatment-emergent "Hallucinations involving visual and/or tactile sensations of insects, snakes, or worms…" whereas none of the children on placebo hallucinated or became psychotic.
Further underscoring that the drugs are to blame: Dr. Andrew Mosholder and colleagues report, that in 90% of the cases, "there was no reported history of a similar psychiatric condition." The authors note: "Patients and physicians should be aware that psychosis or mania arising during drug treatment of attention-deficit/hyperactivity disorder may represent adverse drug reactions."
The findings have finally been published by the Amer Academy of Pediatrics in its journal, Pediatrics (Abstract below).
It is exceedingly troubling that publication of such vital drug safety information was held up for three years–especially since this analysis had been vetted at the FDA.
One can only suspect that the delay was due to major conflicts of interest–the worrisome scientific findings collide with the financial interests of the American Academy of Pediatrics.
AAP- ADHD diagnostic criteria (2000) expand the roster of children who will be "diagnosed" with ADHD–indeed, they recommend AGAINST screening for possible biological malfunctions: "the AAP recommends that other diagnostic tests be discarded in determining an ADHD diagnosis. Screening for high lead levels, for example, or abnormal thyroid hormone levels should not be considered a routine corollary in the ADHD diagnosis."
AAP Treatment recommendations promote the use of drugs:
The ADHD Management Plan – Sample 1 outlines behavior improvement goals and a medication schedule with details regarding timing and possible side effects.
Sample 2 outlines behavior improvement goals and a simple medication schedule.
Contact: Vera Hassner Sharav
Hallucinations and Other Psychotic Symptoms Associated With the Use of Attention-Deficit/Hyperactivity Disorder Drugs in Children.
Andrew D. Mosholder, MD, MPHa, Kate Gelperin, MD, MPHa, Tarek A. Hammad, MD, PhD, MSc, MSa, Kathleen Phelan, RPha, Rosemary Johann-Liang, MDb.
Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland; bHealth Resources and Services Administration, Department of Health and Human Services, Rockville, Maryland
Vol. 123 No. 2 February 2009, pp.
OBJECTIVES. To gain a better understanding of the capacity of psychostimulant medications to induce adverse psychiatric reactions and determine the frequency of such reactions, we analyzed postmarketing surveillance data and clinical trial data for drugs, either approved or under development, for the treatment of attention-deficit/ hyperactivity disorder.
METHODS. The US Food and Drug Administration requested manufacturers of drugs approved for attention-deficit/hyperactivity disorder or with active clinical development programs for that indication to search their electronic clinical trial databases for cases of psychosis or mania using prespecified search terms.
The manufacturers supplied descriptions of clinical trials, numbers of patients exposed to study drug, and duration of exposure to permit calculations of incidence rates. Independently, cases of psychosis or mania in children and adults for drugs used to treat attention-deficit/hyperactivity disorder from the Food and Drug Administration Adverse Event Reporting System safety database were analyzed. Manufacturers were asked to conduct similar analyses of their postmarketing surveillance databases.
RESULTS.We analyzed data from 49 randomized, controlled clinical trials in the pediatric development programs for these products. A total of 11 psychosis/mania adverse events occurred during 743 person-years of double-blind treatment with these drugs, and no comparable adverse events occurred in a total of 420 person-years of placebo exposure in the same trials. The rate per 100 person-years in the pooled active drug group was 1.48. The analysis of spontaneous postmarketing reports yielded 800 reports of adverse events related to psychosis or mania. In 90% of the cases, there was no reported history of a similar psychiatric condition. Hallucinations involving visual and/or tactile sensations of insects, snakes, or worms were common in cases in children.
CONCLUSIONS. Patients and physicians should be aware that psychosis or mania arising during drug treatment of attention-deficit/hyperactivity disorder may represent adverse drug reactions. Pediatrics 2009;123:611-616
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