Ritalin, the drug used to treat Attention Hyperactivity Disorder has been linked to suicidal thoughts, hallucinations and aggressive and violent behaviour.
And the US Food and Drug Administration wants new safety warnings to be placed on the labels of the medicine it has also linked to heart problems.
“We intend to make labelling changes to describe these events,” the FDA told a two-day meeting which was held in Washington in June.
Ritalin was placed on the Pharmaceutical Benefits Scheme in Australia this week, which means it now attracts a government subsidy.
Doctors and ADHD support groups yesterday hit out at criticism of the subsidy, claiming those who blame parents for the attention and hyperactivity problems are ignoring hundreds of world studies. And they say it won’t lead to increased prescribing of the drug.
“There are 250 international studies from different continents showing the effect and benefits of medication as part of a plan,’ Learning Difficulties Coalition president Jude Foster said.
Subsidising Ritalin meant that families had a real choice in which medication they used to treat their children, previously only dexamphetamine had attracted a subsidy, she said yesterday.
Australia’s drug watchdog the Therapeutic Goods Administration says it will monitor the US labelling changes but it believes the side effects are already well described in information inserts in drug packets distributed here.
The US move was prompted by post-marketing reports on the medicine which showed that people using the medicine had experienced hallucinations, suicidal thoughts and psychotic behaviour.
They also demonstrated aggressive and violent behaviour.