
The Therapeutic Goods Administration has rejected claims that its adverse reaction reports indicated an "alarming" growth of severe psychotic episodes in children taking drugs to treat attention deficit hyperactivity disorder (ADHD).
Sydney's Daily Telegraph newspaper today published an article which claimed that at least 30 children taking ADHD drugs experienced psychotic episodes, including suicidal thoughts.
Basing the claim on apparent data from the TGA, the paper alleged that the number of adverse reactions to ADHD drugs in children had doubled in three years.
However a TGA spokesperson told Pharmacy News that the paper's conclusions were based on "raw data taken out of proportion" and there was no report indicating "cause and effect" between the drugs and the alleged adverse events.
National Prescribing Service chief executive Dr Lynn Weekes said the reported adverse reactions were "consistent with the side effect profile" of ADHD drugs but urged caution over making any direct links.
"Reports to TGA are of a suspected link between a drug and the adverse event and so no single event can be assumed to be causal," Dr Weekes said.
"Rates of reporting to TGA are influenced by a number of factors including media coverage and prevalence of use. So while we can't definitely conclude that ADHD medications have directly led to the adverse effects reported, we should take the increase in reports of suicidal thoughts seriously and continue to monitor children closely for side effects."
The Daily Telegraph cited a case of one seven-year-old boy who tried to commit suicide while on Ritalin (methylphenidate).
More than 480,000 prescriptions were issued for Ritalin, fellow methylphenidate brand Concerta, Strattera (atomoxetine) and dexamphetamine during the past year.
At the start of October, PBS subsidy for Concerta extended release formulations were extended to adults.