Harrison attempted suicide when he was five. Why this asthma drug was linked

A common asthma drug used by children has been linked to three suicides in Australia and hundreds of other medical episodes since a federal government safety review six years ago, prompting a renewed push from families to add better warnings to packaging.

The Therapeutic Goods Administration (TGA) and the Pharmaceutical Society of Australia are considering updating product information and labelling rules warning consumers about the link between drugs containing montelukast and neuropsychiatric side effects, after campaigning by families with children affected by the drug.

Harrison Sellick (18), who was on montelukast from the age of two, survived several suicide attempts while taking and withdrawing from the drug. His mother Vanessa is campaigning for better awareness of the potential neuropsychiatric side effects of the drug.

Drugs containing montelukast have been associated with at least 200 adverse events reported to the TGA in the past decade. These include dozens of reports of suicidal thoughts and behaviours, nightmares and other psychiatric disorders. Children as young as two have shown signs of depression and violent behaviour.

Several young Australians using the drug – commonly sold under the product name Singulair – have taken their own lives, including a 23-year-old man who died in July 2023, a 17-year-old girl who died in February 2021, and a 21-year-old man who died in 2020.

Singulair was the suspected drug in these reports to the TGA. However, adverse-event notifications do not mean the event has been confirmed or that the reported suicides were related to the medicine.

In a submission to the TGA, one mother said her eight-year-old daughter had been shifted off her preventer and ventolin and onto montelukast by someone who was not their regular GP, but was “raving about the effects” of the drug.

Her breathing improved within a week, but their regular doctor immediately expressed concerns about montelukast and told them to monitor changes in her mental health as she was “a little bit anxious anyway”.

When they noticed she was struggling to stay in bed and play sport, they pulled her off the drug – but the withdrawal symptoms were “almost immediate”.

“She gets angry, frustrated and has zero patience. Just a completely different girl,” she said. “Had I known how severe the side effects of this medication could be, I would never have allowed it to be put into my child’s body.”

Montelukast is listed on the Pharmaceutical Benefits Scheme for children under 14.

At least 107,700 prescriptions were dispensed to more than 27,600 Australian patients in the past financial year through the Pharmaceutical Benefits Scheme. This number doesn’t include private prescriptions.

The TGA recommended a number of changes in 2018 following a safety review, recommending packaging changes, better reporting of neuropsychiatric events associated with montelukast, and updated education guidelines for doctors and pharmacists handling the drug.

Vanessa Sellick, who has been campaigning for better regulation in Australia since her son Harrison survived several suicide attempts while taking and withdrawing from the drug, said not enough people were being warned by doctors and pharmacists about the potential side effects of the drug.

“It happens more than it used to, but it still doesn’t happen all of the time,” she said.

“Our son had a suicide attempt at five years old during withdrawal from montelukast. He had been suffering side effects. When we stopped the side effects intensified for a while.”

Sellick said it was terrifying.

“He had an overactive flight response so would flee from the house or from school. He was making dark comments about wanting to die. These started at four years old,” she said.

“As a mother, this whole experience has ripped my heart in two. There is nothing more excruciating than watching your child suffer. We did not know how to help him and not one of our doctors made the connection between his struggles and the medication.”

Professor Bandana Saini, a pharmacist and asthma researcher at the University of Sydney, said she discusses the potential side effects of montelukast when training new pharmacists even if the risk of developing severe neuropsychiatric side effects on montelukast were low.

She said Australia should follow Europe and the United States and add a “box warning” to the medication, but that must also be combined with a verbal warning from a doctor explaining the side effects and strategies to mitigate the risk.

”That conversation between the patient and the prescriber is really quite important because some people may not even look at the box,” she said. “There’s also that balance of not worrying or scaring parents particularly about side effects … and then having a child suffer an asthma episode that might be equally life-threatening.”

Pharmacists could also be required to add a fluorescent cautionary label to prescriptions containing montelukast, as a Pharmaceutical Society of Australia review group considers research and submissions from families and stakeholders.

Saini said montelukast, which comes in tablet form, was useful for treating asthma in children “because it’s very difficult to teach children to use inhalers”.

The European Medicines Agency recommended a box warning on medications containing montelukast in December, while warning labels have accompanied the drug in the United States since the Food and Drug Administration updated its rules in early 2020.

Merck, the producer of Singulair, was contacted for comment about the labelling of the product.

A federal health department spokeswoman confirmed there was a known association between montelukast and neuropsychiatric events and, “in rare cases”, suicidal thinking and behaviour.

“These risks are well documented in both the Product Information (PI) and Consumer Medicine Information (CMI), which are the documents used by health professionals and consumers in Australia to communicate safety information about a medicine,” she said.

The spokeswoman said a number of guidelines had been updated since the 2018 TGA review.

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