Australia’s Therapeutic Goods Administration has ordered warning labels on an asthma medication prescribed to millions of children that has been linked to suicidal thoughts, hallucinations and other psychiatric conditions.
U.S. government-backed research found that montelukast, sold under the brand name Singulair, binds to brain cells that control mood, decision-making, attention, impulse control and sleep.
Over the past decade, the TGA has received approximately 200 reports of behavioral side effects associated with montelukast in Australia.
This includes 57 cases of depression, 60 cases of suicidal thoughts and 17 suicide attempts or incidents of intentional self-harm.
There were seven cases in which patients taking the drug committed suicide.
Although these figures are worrying, Nial Wheate, professor of pharmaceutical chemistry at Macquarie University, highlighted the need to consider them in the context of the number of Australians taking the drug.
«During the same period, more than 200,000 montelukast prescriptions have been filled under the Pharmaceutical Benefits Plan.
“Overall, we don’t know conclusively that montelukast causes depression and suicide, just that it appears to increase the risk for some people.”
Australian-born Harrison Sellick attempted suicide at just five years old, a couple of years after participating in Singulair. His mother Vanessa said he started having “really long meltdowns” from the age of two, as well as “general comments about death and self-hatred.”

Montelukast, sold under the brand name Singulair, is a commonly prescribed medication in Australia.
Dr. Wheate urged anyone with concerns to consult their doctor.
‘If you have asthma and your child is taking montelukast, you should not simply stop taking the medication, because this could put you at risk of having an attack that could be life-threatening.
“If you’re concerned, talk to your doctor, who can discuss the risks and benefits of the medication for you and, if appropriate, prescribe a different medication.”
Montelukast, given as a daily pill, works by blocking chemicals released by the body that cause the airways to swell and constrict during an asthma attack.
Since the 1990s, it has been commonly prescribed to asthma patients whose condition cannot be controlled with standard treatment.
Controversy surrounding the drug and its potential to cause suicidal ideation has circulated for years.
Campaigners have repeatedly called for more to be done to educate patients and parents about the potential risk.
These calls have now been amplified after the results of research into the drug and its impact on the brain were revealed in the United States.
Presented at the American College of Toxicology last year, representatives from the U.S. Food and Drug Administration’s National Center for Toxicological Research confirmed that there is a link between the drug and psychiatric conditions.
They said laboratory tests had shown “significant binding” of montelukast to multiple receptor cells found in the brain and is highest in cells known to be involved with psychiatric effects.
However, experts did not suggest that the drug should be withdrawn from sale or banned, adding that its studies are still ongoing and the results have not yet been finalized.
Singulair was a hugely successful product for Merck after its launch in 1998, offering relief for asthmatics in a pill as an alternative to an inhaler.
A 2017 analysis by Kiplinger, a business forecasting company, suggested that the drug had generated nearly $50 billion in sales for Merck since it came to market.
In early advertisements, the company said the side effects were so benign that they were “similar to a sugar pill,” while the label said the effect on the brain was minimal.
As of 2019, health authorities had received thousands of reports detailing psychiatric episodes in patients prescribed the drug, including dozens of cases of suicide.
Among them was Melbourne boy Harrison Sellick, who attempted suicide when he was just five years old.
According to his mother Vanessa, Harrison was prescribed montelukast when he was two years old, but over the next three years he developed behavioral problems and suicidal thoughts.

Virginia native Nicholas England shot himself in the head at age 22, just weeks after taking the generic version of Singulair.
Sellick told Daily Mail Australia that her son, now 17 and not taking medication, tried to take his own life when he was just five years old: “He started having very long seizures that lasted an hour and a half.” There were general comments about death and self-hatred.’
In another heartbreaking story, Robert England’s 22-year-old son Nick committed suicide in 2017, less than two weeks after starting taking montelukast.
England remembers her son having trouble sleeping before he died, and said he was completely healthy and had no mental health problems before taking the medication.
“He was only on that medication for a few days, literally just a few days,” England said. “It completely changed the trajectory of our lives.”
Organon, a Merck subsidiary that now markets Singulair, said in a statement following news of the US research that it is confident in the drug’s safety profile.
“The Singulair product label contains adequate information about the benefits, risks, and reported adverse reactions of Singulair,” the company said.