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University of Otago
A world-first New Zealand study of children's treatment with
"atypical antipsychotic" drugs is providing new insights into why they
are being prescribed and what adverse reactions can result.
The Intensive Medicines Monitoring Programme (IMMP) study investigated
the safety and use of the drugs in all under-16-year-olds in New
Zealand prescribed them between April and July in 2003.
Adverse reactions in the children were monitored until the end of
November 2004 and doctors were surveyed on what particular diagnoses
and symptoms prompted the prescriptions.
Co-author Dr Mira Harrison-Woolrych says this is the first study
anywhere to paint a comprehensive, real-life picture of how the
increasingly-prescribed second-generation antipsychotics are being used
in children.
Their findings appear in the international journal, Drug Safety.
More than 90 per cent of the prescriptions in the 420 children were for
Risperidone, sold under the trade names Risperdal and Ridal in New
Zealand. Risperidone was added to the list of government-subsidised
medicines in 1998.
Adverse events were identified in 30 per cent of the children and the
researchers linked one-third of these to the antipsychotics.
"Weight gain, tooth decay and sleepiness were the most common adverse
events we found," says Dr Harrison-Woolrych who directs the IMMP, which
is based at the University of Otago.
An unexpected finding was that symptoms of depression - previously
unidentified as an adverse reaction of risperidone in children -
emerged in four children during their treatment, she says.
Child psychiatrist and co-author Dr Juan Garcia-Quiroga says while it
is not certain that risperidone use was responsible, people need to be
aware of the possible link.
"More research is required, but because of the potentially serious
consequences, clinicians and carers should look out for the emergence
of these symptoms," says Dr Garcia-Quiroga.
As well as gathering comprehensive data on the adverse reactions, the
researchers also investigated the children’s diagnoses and which
symptoms were being targeted.
They found conduct disorders and attention deficit and hyperactivity
disorder were the most common diagnoses reported in the children,
followed by autism, Asperger's syndrome and other developmental
disorders.
A unique feature of the study was that it asked which specific symptoms
had prompted treatment with the medicines and this approach yielded
clinically relevant data, says Dr Garcia-Quiroga.
Aggression and difficult behaviours were found to be the most common target symptoms, he says.
The United Kingdom health medicines regulatory body has already shown interest in the IMMP findings, says Dr Harrison-Woolrych.
"While prescriptions of these medicines in children and adolescents
have increased vastly worldwide, there has been a lack of good evidence
about their long-term safety.
"By taking advantage of the IMMP's unique prescription event monitoring
and record linkage capabilities we were able to add important knowledge
about this area."
Editor's Note:
Original news release can be found here.
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