Concerns over the potential risk of sudden death in children with ADHD treated with stimulant drugs have prompted an investigation by drug regulators.
The US Food and Drug Administration is reviewing all studies in this area and has commissioned a study of its own to report later this year. The MHRA and EU drug regulators will then review its conclusions.
The move follows a study published in the American Journal of Psychiatry which looked at sudden unexplained deaths in 564 children and found 1.8% were taking stimulant drugs. This compares to just 0.4% of those in a control group of children who died in road traffic accidents.
A FDA statement said: ‘The FDA is continuing its review of the strengths and weaknesses of this and other epidemiological studies that evaluate the risks of stimulant medications used to treat ADHD in children.’
But it urged parents not to stop their child’s treatment on the basis of this study.
Professor Eric Taylor, chair of the NICE guideline development group for ADHD and head of department of child and adolescent psychiatry at the Institute of Psychiatry, said he had a paper due to be published on ADHD stimulant drug data from general practice. He said: ‘It’s clear that if there is a risk, then it is an exceedingly low risk – about one in a million. Probably there is no risk at all.
‘What GPs do need to know is that children taking stimulants can have raised blood pressure or palpitations and these need monitoring,’ he said.
A spokesperson from the MHRA said it would consider the implications of the FDA review’s findings – along with other soon to be completed studies- and then decide if any regulatory action is required.
By Nigel Praities
Source - http://www.pulsetoday.co.uk/story.asp?sectioncode=23&storycode=4123033&c=2
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