Media reports have prompted Federal Minister for Health Greg Hunt to order an urgent investigation into the psychiatric adverse effects of montelukast in children.
The minister has told the TGA to follow up concerns raised in a 9 News report about psychiatric effects of the drug following the suicide of a teenager in the US who had been taking the montelukast for asthma.
In the program, the Australian parents of the teen said they had not been told by doctors about the possible adverse effects of montelukast.
The program noted that montelukast’s product information listed depression, increased aggression, hallucinations and nightmares as possible adverse effects.
However it said the warnings were not put on the outside of the product labelling in Australia.
It also featured a Melbourne mother who delivered a petition to the minister calling for montelukast warning labels after her 12 year old son started having suicidal thoughts while taking montelukast.
A spokesman for the health minister said the concerns raised in the program would be investigated.
“The Minister has asked the Therapeutic Goods Administration to conduct an urgent review and provide advice to the government on this matter.”