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FOOD & DRUG ADMINISTRATION:

A new FDA report (dated March 3, 2006) contains yet more warnings about the dangers of ADHD drugs.   From the executive summary: 

“The most important finding of this review is that signs and symptoms of psychosis or mania, particularly hallucinations, can occur in some patients with no identifiable risk factors, at usual doses of any of the drugs currently used to treat ADHD.”  (page 3) 

“Numerous … reports of aggression or violent behavior during drug therapy of ADHD have been received ... approximately 20% of cases overall were considered life-threatening or required hospital admission.”

“Also of note, a striking majority (80 to 90% overall) of patients identified in this review had no prior history of similar events.”  (page 4) 

 

FROM THE FDA’s “SELECTED CASE NARRATIVES”:

“A 5 year old male … woke up crying and screaming that he had bugs crawling on him. … hallucinations stopped when Adderall XR was stopped.”  (page 10) 

“A 6-year-old boy … developed hallucinations of spiders under the mattress…. Concerta was stopped and the patient recovered.”  (page 12) 

“A 7-year-old boy with ADHD … reported seeing and feeling snakes crawling on and around him starting approximately one hour after drug [Ritalin] ingestion.” (page 16)   

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SEE FULL REPORT ON FDA HOME PAGE:

http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4210b_11_01_AdverseEvents.pdf