AN asthma drug prescribed to kids can cause suicidal thoughts, hallucinations and other psychiatric conditions.
US government-backed research found that montelukast binds to brain cells controlling mood, decision-making, and attention.
The fresh research was sparked by thousands of heartbreaking stories from families of children on montelukast.
This included Harrison Sellick, from Melbourne, Australia, who tried to take his own life at just five years old.
Another was Harry Miller from London, England, who was 14 when he killed himself in 2018 after taking the asthma drug.
Montelukast – also known as Singulair – was prescribed more than 4million times in the UK in 2022, according to NHS figures.
The montelukast UK action group estimates at least 35,000 of these were children.
In the US, around 12 million people in the US take montelukast, with 1.6 million of them being kids under 18.
The 25-year-old medication is used to treat asthma symptoms and is regularly given to children as young as six months old.
Since 1998, 82 suicides have been linked to montelukast in the US, Food and Drug Administration (FDA) reports.
The drug has also been tied to depression, anxiety, nightmares, agitation, and even full-blown psychosis.
It’s unclear how many suicides in the UK are linked to montelukast.
However, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has received around 1,205 reports of psychiatric side effects tied to the drug since 1998.
Of these, almost half (551) involved children under nine.
The complaints were submitted through the Yellow Card scheme, which allows patients and healthcare professionals to report adverse reactions.
In the US and Europe, the medicine’s box sports a black box label; the strictest warning that indicates the medication can lead to death or serious injury.
The US and Australia have no such warning on its montelukast boxes, as of yet.
The montelukast UK action group is calling for more prominent warnings of the drug’s possible side effects.
In March, the MHRA confirmed that the drug is under review.
The MHRA issued an important safety announcement in September 2019 highlighting the potential for “neuropsychiatric reactions”.
These can include “speech impairment and obsessive-compulsive symptoms”, it said.
Some patients have reported suffering hallucinations, including one child who said they saw red-eyed demons and melting walls.
The NHS lists mood changes, depression, aggression and thoughts of self-harm among the drug’s serious side effects.
The FDA’s National Center for Toxicological Research shared new findings at the American College of Toxicology’s annual meeting this week.
They confirmed earlier complaints linking the asthma drug montelukast to psychiatric issues in some patients.
Researchers are still unclear on how the drug affects brain cells, but Julia Marschallinger, a neurology researcher at Stanford, said: “It’s definitely doing something that’s concerning.”
EVERY 90 minutes in the UK a life is lost to suicide.
EVERY 90 minutes in the UK a life is lost to suicide.
It doesn’t discriminate, touching the lives of people in every corner of society – from the homeless and unemployed to builders and doctors, reality stars and footballers.
It’s the biggest killer of people under the age of 35, more deadly than cancer and car crashes.
Yet it’s rarely spoken of, a taboo that threatens to continue its deadly rampage unless we all stop and take notice, now.
That is why The Sun launched the You’re Not Alone campaign.
The aim is that by sharing practical advice, raising awareness and breaking down the barriers people face when talking about their mental health, we can all do our bit to help save lives.
Let’s all vow to ask for help when we need it, and listen out for others… You’re Not Alone.
If you, or anyone you know, needs help dealing with mental health problems, the following organisations provide support:
Years of analysis and new studies pushed the FDA to investigate why montelukast might trigger side effects like depression, anxiety, agitation, and thoughts of self-harm.
Preliminary results, presented in Austin this week, showed “significant binding” of montelukast to several brain receptors, said Jessica Oliphant, deputy director at the FDA’s toxicology research centre.
Her team also confirmed earlier findings that the drug enters rat brains, though more research is needed on how it builds up in the body.“
“These findings show that montelukast concentrates in brain regions tied to psychiatric effects,” Jessica added.
FDA slides, reviewed by Reuters, compared montelukast to antipsychotic drugs like risperidone, known for their neuropsychiatric effects.
While the findings back to earlier concerns, the research doesn’t suggest montelukast should be banned.
The FDA stressed the studies are ongoing, and conclusions aren’t final.
Still, their investigation isn’t the first time scientists have raised concerns about the drugs.
