HARRY Miller was just 14 when he started hearing voices and feeling “scared”.
The “really good kid” attended three church youth groups a week, but began having tantrums after a doctor first prescribed him the asthma medication montelukast in 2016.
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The pills have been linked to depression, aggression and suicidal thoughts, but her parents, Graham and Allison, say they were not informed of the risks at the time.
Allison came home to find feathers everywhere after Harry attacked a pillow with a kitchen knife in an “out of character” outburst one night.
And on February 11, 2018, after a trip to the Science Museum, the family found Harry dead in his room by suicide.
Graham, from south-west London, told The Sun: “It was an absolute horror.
“We finished at the museum and thought about going to Pizza Express and sent him a message. My wife was worried because he didn’t respond.
“I was thinking, ‘Ali, don’t worry. He’s a teenager.’
“We got home and luckily my kids didn’t go in because my wife was going in to check on him.
“My wife found Harry and called me, and I was tasked with giving my son mouth-to-mouth resuscitation while we waited for the ambulance.
“Parents’ pain – it’s like no other in these situations. Simply terrible. It was a big shock for me. I had no idea we were going to get into this.”
Montelukast – also known as Singulair – was prescribed more than 4 million times in the UK in 2021, according to NHS data.
The 25-year-old medicine is used to treat asthma symptoms and is regularly given to children from six months of age.
However, the Medicines and Healthcare products Regulatory Agency issued an important safety announcement in September 2019, highlighting the potential for “neuropsychiatric reactions”.
These can include “speech difficulties and obsessive-compulsive symptoms,” he said.
Some patients reported experiencing hallucinations, including a child who said he saw demons with red eyes and melting walls.
The NHS lists mood swings, depression, aggression and thoughts of self-harm among the drug’s serious side effects.
In addition to the psychological problems linked to the drug, Harry began to suffer from tremors in his hands – another known side effect.
This thing is like a sledgehammer in people’s lives. The absolute horror it causes
Graham Miller
He was referred to the SNS’s child and adolescent mental health services in January 2018, a month before he committed suicide, due to the problems he suffered.
However, he was never able to attend the appointment because the invitation was sent to the wrong person, Graham said.
He and Allison only learned of the drug’s potentially devastating side effects two years after Harry’s death and now want their inquest reopened.
Graham said: “This thing is like a sledgehammer in people’s lives. The absolute horror it causes.
“We’ve been here for six years and I go to counseling every week. It’s a miracle I get out of bed every day.”
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The MHRA is currently reviewing the drug again and is in the final stages before announcing the outcome to healthcare professionals and patients.
Campaigners, including Graham and Allison, call for the use of US and EU-style “black box warning” labels on medicine packaging.
Graham said: “We were thinking, what the hell is causing this shaking.
“In America it was always according to instructions, but it wasn’t there in the UK. I remember thinking, damn – this killed my son.
“This thing is important. It has a real impact on people. I think we need to be a little more careful when deciding to give psychoactive drugs to children.”
But healthcare professionals have suggested it may be more effective to ensure there is better communication between medical professionals and patients so they can detect symptoms.
Thorrun Govind, a pharmacist and health lawyer, said: “I think we should be aware that this is a medicine given to children.
“I completely understand where families’ concerns are coming from, and we need to balance prescribing a medication that is generally safe but can have these side effects.
“Emphasis should be on prescribers and pharmacists informing parents of what to watch out for because they are more likely to detect symptoms.
“Patient information leaflets should be easier to use so people are aware of the dangers.”
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Professor Alastair Suttclife, a pediatrician at University College London, worked on a review of montelukast and its possible links to suicide in 2012.
At the time, an allergy consultant told him his nephew was taking the medication and said it was like “1,000 hammers hitting my head”.
So far, research has found no significant increased risk of suicide in asthma patients – who are already at higher risk – who take the medication.
And it often means patients don’t need to take other asthma medications, such as steroids, which have also been linked to mood swings.
Professor Sutcliffe said parents should still be aware of mental health symptoms if their child is prescribed it.
He said: “If your child is prescribed montelukast and they start complaining about being in a bad mood or showing signs of mental distress, then safety says they shouldn’t take it.”
Patients should not stop a prescription medication like montelukast without first consulting their doctor.
OFFICIAL REVIEW
Dr Alison Cave, from the MHRA, said: “Patient safety is our top priority.
“We have been conducting a review to thoroughly investigate new data on the risk of neuropsychiatric reactions with montelukast, including indicators of lack of risk awareness among patients, caregivers and healthcare professionals and whether any further regulatory action is needed.
“We listen and learn from patients’ experiences and this information forms an important part of our assessments and decision-making.
“We keep all medicines under ongoing review and are working to address the concerns raised and will provide an update upon completion of our review.”
She added: “We encourage patients and carers to report any adverse drug reactions they experience with montelukast to us through our Yellow Card scheme.
“We also advise patients and carers to speak to their GP or pharmacist if they experience any neuropsychiatric symptoms whilst using montelukast.”
An Organon spokesperson said: “Nothing is more important to Organon than the safety of our medicines and the people who use them.
“Reports of adverse events are taken seriously and, as with all of our medicines, we continually monitor the safety of Singulair.
“We remain confident in the safety profile of montelukast sodium when used in accordance with the MHRA-approved Summary of Product Characteristics and Patient Information Leaflet.
“We are committed to working with regulators to label our products appropriately, allowing healthcare professionals to make informed decisions about the products they prescribe.
“We are confident that, together with the MHRA, we have communicated to healthcare professionals and patients complete and appropriate information about the safe and effective use of montelukast sodium.”
YOU ARE NOT ALONE
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 TV stars and footballers.
It is the biggest cause of death for people under 35, deadlier than cancer and car accidents.
Yet it is rarely spoken of, a taboo that threatens to continue its deadly rampage unless we all stop and pay attention, now.
That’s 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 part to help save lives.
Let’s all promise to ask for help when we need it and listen to others… You are not alone.
If you, or someone you know, needs help dealing with mental health issues, the following organizations will provide support:
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