Warning of ‘suicide risk’ from commonly prescribed drug – and kids may be more at risk

AN asthma drug prescribed to kids can cause suicidal thoughts, hallucinations and other psychiatric conditions, regulators say.

US government-backed research found that montelukast binds to brain cells controlling mood, decision-making, and attention.

4

4

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 died by suicide in 2018 after taking the asthma drug.

Montelukast - also known as Singulair - was prescribed more than four million times in the UK in 2022, according to NHS figures.

Read more on Montelukast

DRUG ALERT

Common asthma & hay fever drug 'can cause suicidal thoughts & hallucinations'

DRUG ALERT

Dad's 'horror' at finding son, dead after 'asthma drug triggered hallucinations'

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.

There have been 82 suicides linked to montelukast since 1998 in the US, the Food and Drug Administration (FDA) reports.

Most read in Health

SICK OF IT

Six Christmas ‘food hygiene fails’ that could leave guests with food poisoning

A&E PRESSURE

'Critical incidents' declared at hospitals - map shows where to 'stay away'

PARENT WARNING

My baby is spending first Christmas in hospital after catching killer 'cold'

MUM'S AGONY

I had to put my son's Xmas presents in his coffin after a sudden coughing fit

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 UK 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. 

4

4

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.

'It's definitely doing something that's concerning'

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."

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 , 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.

READ MORE SUN STORIES

MOVING ON

BBC star quits after 24 years on air saying 'what a privilege it's been'

ruth-less

Eamonn Holmes blindsided by ‘TV wife's’ sudden departure in another brutal blow

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.