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Government researchers have found that a widely prescribed asthma drug originally sold by Merck & Co may be linked to serious mental health problems for some patients, according to a scientific presentation reviewed by Reuters.

The US researchers found that the drug, sold under the brand name Singulair and generically as montelukast, attaches to multiple brain receptors critical to psychiatric functioning.

Singulair was a blockbuster product for Merck after its launch in 1998, offering relief in a pill as an alternative to an inhaler. In early advertising, the company said the side effects were so benign that they were “similar to a sugar pill,” while the label said any distribution in the brain was “minimal.” Generic versions are still prescribed to millions of adults and children every year.

But by 2019, thousands of reports of neuropsychiatric episodes, including dozens of suicides, in patients prescribed the drug had piled up on internet forums and in the US Food and Drug Administrations tracking system. Such “adverse event” reports do not prove a causal link between a medicine and a side effect, but are used by the FDA to determine whether more study of a drugs risks are warranted.

After years of analysis, the reports and new scientific research led the FDA in 2020 to add a “black box” warning to the montelukast prescribing label, flagging serious mental health risks like suicidal thinking or actions.

The agency also convened a group of internal experts around the same time to look into why the drug might trigger neuropsychiatric side effects.

The results of the group’s work, which are preliminary and have not been previously reported or released publicly, were presented to a limited audience at the American College of Toxicology meeting in Austin, Texas on Wednesday.

The FDA said it does not plan to update the drug label based on data from the presentation.

The behavior of montelukast appears similar to other drugs known to have neuropsychiatric effects, such as the antipsychotic risperidone, according to FDA slides reviewed by Reuters. The FDA has cautioned that its studies are ongoing, and results have not been finalized.

When the FDA added the black box, it cited research from Julia Marschallinger and Ludwig Aigner at Austria’s Institute of Molecular Regenerative Medicine.

The two scientists told Reuters on Thursday the new data showed significant quantities of montelukast present in the brain. The receptors involved play a role in governing mood, impulse control, cognition and sleep, among other functions, they said.

The research does not show whether that binding mechanism leads directly to harmful effects in individual patients, or who is particularly at risk, the two scientists said. However, Marschallinger said the new data bolsters reports from people who reported suffering side effects.

“It’s definitely doing something that’s concerning,” she said.

A Merck representative did not respond to questions. Organon, a Merck spinoff that now markets Singulair, said in a statement it is confident in the drug’s safety profile.

“The product label for Singulair contains appropriate information regarding Singulair benefits, risks and reported adverse reactions,” the company said.

Reuters reported last year that the FDA had received thousands of reports of patients, including many children, experiencing depression, suicidal thoughts and behaviors, or other psychiatric problems after they began using montelukast.

By 2019, the FDA tallied 82 suicides linked to Singulair and its generic versions reported to its adverse-event database since 1998. At least 31 of those reports involved someone 19 or younger.

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Robert England’s 22-year-old son Nick killed himself in 2017 less than two weeks after starting montelukast. England recalls that his son had trouble sleeping before he died, and said he was completely healthy and had no mental health problems prior to taking the drug.

“He was on that medication for just days, literally just days,” England said. “It completely changed the trajectory of our lives.”

The Reuters report also detailed lawsuits alleging that Merck knew from its early research that the drug could impact the brain and minimized the potential for psychiatric problems in statements to regulators. Many of those lawsuits are still pending.

If you are struggling with suicidal thoughts or are experiencing a mental health crisis and live in New York City, you can call 1-888-NYC-WELL for free and confidential crisis counseling. If you live outside the five boroughs, you can dial the 24/7 National Suicide Prevention hotline at 988 or go to SuicidePreventionLifeline.org.

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Fourteen children arrested on suspicion of manslaughter over Gateshead fire released on bail

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Fourteen children arrested on suspicion of manslaughter over Gateshead fire released on bail

All 14 children arrested on suspicion of manslaughter after a boy died in a fire have been released on police bail, officers said.

Layton Carr, 14, was found dead near the site of a fire at Fairfield industrial park in the Bill Quay area of Gateshead on Friday.

Northumbria Police said on Saturday that they had arrested 11 boys and three girls in connection with the incident.

In an update on Sunday, a Northumbria Police spokesman said: “All those arrested have since been released on police bail pending further inquiries.”

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Teenager dies in industrial estate fire

Firefighters raced to the industrial site shortly after 8pm on Friday, putting out the blaze a short time later.

Police then issued an appeal for Carr, who was believed to be in the area at that time.

In a statement on Saturday, the force said that “sadly, following searches, a body believed to be that of 14-year-old Layton Carr was located deceased inside the building”.

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David Thompson, headteacher of Hebburn Comprehensive School, where Layton was a pupil, said the school community was “heartbroken”.

Mr Thompson described him as a “valued and much-loved member of Year 9” and said he would be “greatly missed by everyone”.

He added that the school’s “sincere condolences” were with Layton’s family and that the community would “rally together to support one another through this tragedy”.

A fundraising page on GoFundMe has been set up to help Layton’s mother pay for funeral costs.

Pic: Gofundme
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Pic: Gofundme

Organiser Stephanie Simpson said: “The last thing Georgia needs to stress trying to pay for a funeral for her Boy Any donations will help thank you.”

One tribute in a Facebook post read: “Can’t believe I’m writing this my nephew RIP Layton 💔 forever 14 you’ll be a massive miss, thinking of my sister and 2 beautiful nieces right now.”

Detective Chief Inspector Louise Jenkins, of Northumbria Police, also said: “This is an extremely tragic incident where a boy has sadly lost his life.”

She added that the force’s “thoughts are with Layton’s family as they begin to attempt to process the loss of their loved one”.

They are working to establish “the full circumstances surrounding the incident” and officers will be in the area to “offer reassurance to the public”, she added.

A cordon remains in place at the site while police carry out enquiries.

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Football bodies could be forced to pay towards brain injury care costs of ex-players

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Football bodies could be forced to pay towards brain injury care costs of ex-players

Football bodies could be forced to pay towards the care costs of ex-players who have been diagnosed with brain conditions, under proposals set to be considered by MPs.

Campaigners are drafting amendments to the Football Governance Bill, which would treat conditions caused by heading balls as an “industrial injuries issue”.

The proposals seek to require the football industry to provide the necessary financial support.

Campaigners say existing support is not fit for purpose, including the Brain Health Fund which was set up with an initial £1m by the Professional Footballers’ Association (PFA), supported by the Premier League.

But the Premier League said the fund has supported 121 families with at-home adaptations and care home fees.

From England‘s 1966 World Cup-winning team, both Jack and Bobby Charlton died with dementia, as did Martin Peters, Ray Wilson and Nobby Stiles.

Neil Ruddock speaks to Sky's Rob Harris outside parliament
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Neil Ruddock speaks to Sky’s Rob Harris outside parliament

Ex-players, including former Liverpool defender Neil Ruddock, went to parliament last week to lobby MPs.

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Ruddock told Sky News he had joined campaigners “for the families who’ve gone through hell”.

“A professional footballer, greatest job in the world, but no one knew the dangers, and that’s scary,” he said.

“Every time someone heads a ball it’s got to be dangerous to you. You know, I used to head 100 balls a day in training. I didn’t realise that might affect my future.”

A study co-funded by the PFA and the Football Association (FA) in 2019 found footballers were three and a half times more likely to die of a neurodegenerative disease than members of the public of the same age.

‘In denial’

Among those calling on football authorities to contribute towards the care costs of ex-players who have gone on to develop conditions such as Alzheimer’s and dementia is Labour MP Chris Evans.

Mr Evans, who represents Caerphilly in South Wales, hopes to amend the Bill to establish a care and financial support scheme for ex-footballers and told a recent event in parliament that affected ex-players “deserve to be compensated”.

Greater Manchester Mayor Andy Burnham, who helped to draft the amendment, said the game was “in denial about the whole thing”.

Mr Burnham called for it to be seen as “an industrial injuries issue in the same way with mining”.

In January, David Beckham lent his support to calls for greater support for footballers affected by dementia.

One of the amendments says that “the industry rather than the public should bear the financial burden”.

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A spokesperson for the FA said it was taking a “leading role in reviewing and improving the safety of our game” and that it had “already taken many proactive steps to review and address potential risk factors”.

An English Football League spokesperson said it was “working closely with other football bodies” to ensure both professional and grassroots football are “as safe as it can be”.

The PFA and Premier League declined to comment.

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Terror arrests came in context of raised warnings about Iran, with ongoing chaos in its own backyard

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Terror arrests came in context of raised warnings about Iran, with ongoing chaos in its own backyard

These are two separate and unrelated investigations by counter-terror officers.

But the common thread is nationality – seven out of the eight people arrested are Iranian.

And that comes in the context of increased warnings from government and the security services about Iranian activity on British soil.

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Counter terror officers raid property

Last year, the director general of MI5, Ken McCallum, said his organisation and police had responded to 20 Iran-backed plots presenting potentially lethal threats to British citizens and UK residents since January 2022.

He linked that increase to the ongoing situation in Iran’s own backyard.

“As events unfold in the Middle East, we will give our fullest attention to the risk of an increase in – or a broadening of – Iranian state aggression in the UK,” he said.

The implication is that even as Iran grapples with a rapidly changing situation in its own region, having seen its proxies, Hezbollah in Lebanon and Hamas in Gaza, decimated and itself coming under Israeli attack, it may seek avenues further abroad.

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The government reiterated this warning only a few weeks ago, with security minister Dan Jarvis addressing parliament.

“The threat from Iran sits in a wider context of the growing, diversifying and evolving threat that the UK faces from malign activity by a number of states,” Jarvis said.

“The threat from states has become increasingly interconnected in nature, blurring the lines between: domestic and international; online and offline; and states and their proxies.

“Turning specifically to Iran, the regime has become increasingly emboldened, asserting itself more aggressively to advance their objectives and undermine ours.”

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Anybody working for Iran in UK must register or face jail, government announces

As part of that address, Jarvis highlighted the National Security Act 2023, which “criminalises assisting a foreign intelligence service”, among other things.

So it was notable that this was the act used in one of this weekend’s investigations.

The suspects were detained under section 27 of the same act, which allows police to arrest those suspected of being “involved in foreign power threat activity”.

Those powers are apparently being put to use.

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