An asthma drug taken by hundreds of thousands of Britons could increase the risk of suicide, US research suggests.
Montelukast, sold under the brand name Singulair, is a commonly prescribed medicine in Britain and distributed more than 4 million times in England last year, data backed by the NHS suggests.
But new research backed by the US government has found that it can cross the blood-brain barrier (a membrane designed to protect the brain) and bind to the cells that govern our mood and impulse control.
The study was prompted by worrying reports of children taking or attempting to kill themselves while taking the drug, some as young as five years old.
There are now concerns that the estimated 350,000 Britons taking the drug, including 35,000 children, may be living at a similar risk.
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.
Available since the 1990s, it is typically 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.
Montelukast, sold under the brand name Singulair, is a commonly prescribed medicine in Britain and distributed more than 4 million times in England last year, data backed by the NHS suggests.
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’s annual meeting earlier this month, 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However, experts did not suggest that the drug should be withdrawn from sale or banned, adding that its studies are still ongoing and the results have not yet been finalized.
Patient safety leaflets distributed with montelukast in Britain have described the risk of suicidal thoughts as “very rare” occurring in only one in 10,000 patients.
The UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), said more prominent warnings would be added this year to information leaflets distributed with the medicine.
These are similar to those the US equivalent of the MHRA has added, highlighting the potential risk of “serious neuropsychiatric events” when taking montelukast since 2020.
Yael’s mother, Le’at, 41 (right), a graphic designer, noticed a change in her daughter’s behavior and attitude and began researching all of her daughter’s asthma medications. Ms Borger was shocked to discover that montelukast had “suicidal thoughts” as a side effect.
The MHRA has consistently stated that the benefits of montelukast outweigh the risks for most patients.
Medicines safety incident reports submitted to the MHRA have recorded five reports of suicide among patients taking montelukast, three of them among people aged between 10 and 19 years.
Such reports, which may be made by the public or by doctors, are not a guarantee that a particular medication is associated with a side effect; Such events may simply be coincidences.
The MHRA has previously stated that it has received more than 1,200 reports of suspected neuropsychiatric reactions to montelukast since the drug was approved in the UK in 1998.
About 500 of them were children under 10 years old.
Britons who have lost children to suicide, or nearly had an accident while taking the drug, have insisted there is a link.
One case is that of Harry Miller, from London, who committed suicide at the age of 14 in 2018 after taking the drug.
Available since the 1990s, montelukast is typically prescribed to asthma patients whose condition cannot be controlled with the usual treatment, inhalers.
James Burke, from Leeds, who committed suicide in April 2017, aged 21, after suffering years of anxiety and depression, is another whose death has been linked to the drug.
His mother Sharon, speaking afterwards, said: “James made the final decision to kill himself, but that drug (montelukast) put him in the frame of mind to do it.”
Another was from London, England, who was 14 when he committed suicide in 2018 after taking asthma medication.
And in 2019, the Mail on Sunday shared the story of Yael Borger, who, aged 16, had suicidal thoughts which she believes were triggered by the drug.
Harry’s father Graham said he welcomed the MHRA’s new commitment to clarify warnings about the drug’s potential risks earlier this year.
“We think it brings some meaning to Harry’s death because it alerts other children to the dangers,” he said. the guardian.
Estimates on the number of patients taking montelukast come from a UK action group concerned about the drug’s potential health impacts.
Montelukast was originally developed by the German pharmaceutical company Merck.
Organon, a Merck subsidiary that now markets Singulair, said in a statement following news of the US investigation last week 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.