It seems like it’s all happening in Wales at the moment. Wales Online last week reported on two children who developed suicidal behaviour and change of personalities on montelukast – Singulair.
It was two mother who pieced the story together in the case of their children and confirmed the link to the drug by getting it stopped and seeing the problem clear up. See below and at the attached link for the online complete with video and photographs.
See here Wales Online.
Two Welsh mothers of children with asthma have raised concerns about a drug that is being used to combat the condition. The children had been prescribed a drug called montelukast, but they are worried it has caused their children to have suicidal thoughts and suffer nightmares and hallucinations. The drug can reduce the number and severity of asthma attacks, potentially even saving lives, but some medics have become concerned by its effects on mental health, with parents reporting worrying side effects.
Campaigners across the country are now calling for better warnings of the side effects to be written on the products.
Kayleigh Hodge, from St Julians, Newport, said her eight-year-old daughter Lily tried twice run out into traffic and had extreme nightmares after being given the drug.
“Lily had been in and out of a hospital from an early age because of her asthma,” explained her mum. On an appointment for a review in 2016, the doctor suggested we try this drug. They said that Lily could be a guinea pig. I thought it was great, anything to help my little girl and keep her out of hospital. It was in the form of granules. It was alright to start with and helped with the asthma, but then she started having these terrible nightmares. I thought it might be just a stage she was going through. I brought it up at her next appointment but was told that extreme side effects were very rare.”
But Kayleigh said her daughter started becoming obsessed with death and stopped wanting to go out. Her worried mum said: “She used to love going out every day, but then she started getting really worried about it and one day she had a complete meltdown in the middle of the street. She said she could hear people in her head calling her names and kept saying that her brain felt weird.”
Worried Kayleigh searched online for montelukast side effects and found other parents who had concerns about the drug.
In 2017, the decision was taken to bring Lily off the drug and after an initial ‘flare-up’ when she ran into the road for a second time, her symptoms have since reduced.
Kayleigh said: “I feel really guilty that I allowed her to go on the drug. Every child is different and will have a different reaction, but I just want to warn other parents to be careful.”
Kayleigh’s not the only Welsh mum to raise concerns.
Rachel Masterman, 45, from Caldicot, said her son Robbie began having nightmares after being put on the drug when he was two. She said: “Robbie developed these dreadful night terrors. He would wake up screaming like he was being murdered. He could see things coming out of the walls, spiders, men coming to get him.”
He was also aggressive, but his behaviour improved when he was taken off the drug when he was four. Rachel added: “It took me two years to realise that it could be linked to the prescription. I looked it up on the internet and the side effects he had been suffering were there in black and white. He is still not his normal self. This drug has changed him.”
Official information from the National Institute for Health and Care Excellence describes such side effects as being ‘uncommon’ or ‘rare’.
But a recent study in the European Respiratory Journal found one in eight children developed ‘neuropsychiatric adverse drug reactions’ which were ‘definitely or probably related’ to the drug.
The drug montelukast, sometimes branded as Singulair, is made by pharmaceutical firm MSD. A spokeswoman for the company said: “For the millions of people suffering with asthma or allergic rhinitis, Singulair has been an important treatment option for appropriate patients, including children, for over 20 years. “As with all medications, there can be side effects and these are outlined in the accompanying patient information leaflet. The safety and efficacy of our products is paramount to MSD and we continually collaborate with all relevant authorities on any reviews and promptly implement relevant regulatory recommendations or actions.”
The respiratory journal article these mothers found is Here. It’s an extraordinary article. Extraordinary in the sense that this drug has been clearly causing so many problems but yet these reactions are not common knowledge. It has somehow flown beneath the radar.
Extraordinary in the sense that the journal published it. They do provide an editorial aimed at toning down the explosive message – Here. This is standard journal practice but to give them credit the editorial does not say these difficulties are not happening.
A few years before, the team at QuarterWatch had produced a bulletin on the top 10 drugs causing side effects in children in the United States. Montelukast causing suicidal ideation in children featured at number 2 on the list. So the European Respiratory Journal is really just reporting something that we might have expected anyway – which adds to the surprise.
Why is this drug and related drugs like Zafirlukast – Accolate and pranlukast – Onon remained off radar?
Its not because these are wonderful drugs for asthma. They aren’t. Somehow though they seem to be seen as innocuous – like pain-killers or antibiotics.
There have been very few reports of problems on any drugs from this leukotriene antagonist group to RxISK but we have had prior awareness of problems in that hugely convincing cases of gross behavioural change have come our way leading to criminal charges, which RxISK was able to mitigate.
We would like to get far more reports of all kinds of problems from all ages linked to drugs from this group.
AntiDepAware @AntiDepAware Jun 1
Mother says that her son’s self-inflicted death was caused by asthma drug Montelukast (aka Singulair). https://mol.im/a/7095063 via @MailOnline
This is Nicholas telling his story
This is becoming an international crisis …
In the USA, the FDA’s Pediatric Advisory Committee will meet this fall to review the warnings on Singulair. A group called Parents United for Pharma Safety and Accountability is urging anyone whose child has had problems to report them online to the FDA by June 30, at this link:
In Australia the Montelukast Side Effects group has been organizing for quite awhile. Check them out on Twitter at @MontelukastSE or on their Facebook page:
There is a concerted campaign to “exonerate” this drug through highly dubious research. Prof. Robert Gibbons has reviewed insurance claim data (available only to him apparently) which he claims disprove any link. But then, he performed the same favor for SSRI antidepressants …
More recently, a study done in Taiwan appeared to find no link, and was presented with great fanfare at the US conference of Chest Physicians. But according to PUPSA it’s possible these reactions (which may occur in as many as one in eight kids in Europe) are less common in East Asian children for reasons of genetic variation … and that the study was done in Taiwan precisely in order to get a more reassuring result.
Gosh. Would responsible scientists (or drug companies) really do that?
There appear to be a lot of links to this problems in all age groups just recently
Back in 2014, Martha R.
Popular Asthma Drug’s Deadly Side-Effects Revealed (Once Merck Stopped Making Money from It)
by Martha Rosenberg / AlterNet October 15, 2014
Singulair, Montelukast: Asthma medication linked to serious psychotic episodes in children ABC Australia 7:30 report Mon 5 Sep 2016 “In Australia, it was a very different story. The Therapeutic Goods Administration didn’t insist on box warnings and instead advised doctors to warn their patients about the risks. But the mothers say they were never warned.” https://www.abc.net.au/7.30/singulair,-montelukast:-asthma-medication-linked/7817264
Fiona French Retweeted
APRIL_charity @APRIL_charity Jun 6
I have just been contacted by journalist about #Montelukast #asthma drug #suicides in children. #Neuropsychiatric #ADRs we’re not declared in #clinical trials – any one wishing to contribute to article, please contact me.
As MoS investigation reveals yet more evidence of pill’s sinister side-effects…
Why DID health chiefs clear the asthma drug that can make children suicidal?
As a result of the price drop, in 2016, prescribing watchdog the National Institute for Health and Care Excellence (NICE) issued guidance recommending doctors offer the drug widely – a move that has saved the NHS almost £50 million, with GPs and specialists only prescribing the generic versions, according to official figures.
In the wake of our reports, last night the Medicines And Healthcare Products Regulatory Agency, which is responsible for drug safety in the UK, confirmed an update ‘as a matter of priority’ which will be completed in August.
The new leaflet will read: ‘Patients should be aware that… behaviour and mood related changes have been reported in adults, adolescents and children with montelukast.
Juan Gérvas @JuanGrvas Jun 12
Montelukast. Tartamudez. Advertencia sobre acontecimientos neuropsiquiátricos y nueva reacción adversa identificada (disfemia, tartamudez). Vía @RaulCalvoRico https://www.aemps.gob.es/informa/boletines-AEMPS/boletinMensual/2019/abril/boletin-abril.htm#infoSeg …
Montelukast: warning about neuropsychiatric events and new identified adverse reaction (dyspnea)
Neuropsychiatric events in adults, adolescents and children taking montelukast are already known and appear in the adverse reactions section of the data sheet and the package leaflet. In order to further increase knowledge and awareness of them, warnings on this issue will be reinforced in the product information, indicating that patients and doctors should be alert to the occurrence of neuropsychiatric events. Patients and / or caregivers should be instructed to notify their doctor if these changes occur. The risks and benefits of continuing montelukast treatment should be carefully evaluated should they occur.
Additionally, dysphemia has been identified as a new adverse reaction associated with the medication.
Doctors warned to tell patients powerful asthma drug montelukast can cause suicidal thoughts or hallucinations
Many patients said that montelukast had deeply affected their behaviour
They complained of nightmares and also seeing grotesque things while awake
It is extremely effective at cutting the frequency of severe asthma attacks
By Stephen Adams Health Correspondent For
The Mail On Sunday
Published: 01:02, 22 September 2019 | Updated: 01:13, 22 September 2019
Doctors have been warned to tell patients that a powerful asthma drug can cause suicidal thoughts or hallucinations.
I am worried that we are being punished for speaking up.
Some whistle-blowers did not choose the role of speaking up against medicines that harm, lightly.
I was harmed . Suffered in silence. The system failed me and the support was non-existent.
You are on your own now and we will give you a label so that no one has to acknowledge the harm the medicines induced!
Like Spruce eloquently states:
‘Some medicines can cause temporary harm. They may last decade or two however, sadly, some casualties are ruined for a lifetime!’
There is still a lot of work to be done in terms of changing the current culture and receiving some form of acknowledgement of the harms, that some medicines can induce. CB
My guess is that we must continue to educate the ‘well’ of possible pitfalls in use of so many medications – once the ‘well’ become the ‘unwell’ it is too late. Too late for a return to a fully functional life and, often, too late for their conditions to be taken seriously by the very ones who could make a difference. IF THOSE AT THE TOP REFUSE TO TAKE THE DAMAGED SERIOUSLY THEN WE MUST CONVINCE THE ORDINARY PEOPLE – AND OURSELVES – THAT THE ‘DAMAGED’ WERE ONCE ‘UNDAMAGED’ AND SHOULD BE OUR REMINDERS OF WHAT CAN HAPPEN IF WE MISPLACE OUR TRUST!
Mary I agree with you that the trust issue is a nightmare . I do a simple thing still by using a marker pen to leave messages where ever possible like ‘do you take prescription drugs? – see Rxisk.org’. Who knows if they might alert at least someone..who then alerts some one else. So where do people go when trust is totally lost and help is needed. Some to the groups they can trust rather than massively funded groups controlled by need to please their ‘masters’.. I go to a specialist shop where cannabinoids are sold and advice available – (but have seen the sprays sold in a tacky mini supermarket) the component which gets you ‘high’ is removed, I would prefer to make my own decision as to whether to buy actual cannabis . But the cannabinoids are classed as a food supplement so hopefully the medical establishment won’t get their mitts on them. They apparently work for some people and not others and can have side effects ,so as with other drugs, natural or not, it’s wise to google info as there are different recommended doses and in spray/drops or tablet form . It’s too soon to tell whether they are worth it for me and too expensive to give a proper trial with higher doses but whether they turn out to be a fad, a placebo or something very beneficial is possibly not known yet
At the end of the day, Susanne, if your experimenting works for you ( be it by giving you a feeling of ‘purpose’ or actual improvement) then it’s worth it, not only for yourself but for others who may read your words – here and wherever else you choose to leave your message. This is Shane’s purpose ( with me as spokesperson!) in everything that he does – to be open about what has happened to him and share that with as many different groups of people as he can find. His hope, by doing so, is that it may prevent SOMEONE, SOMEWHERE, from suffering as he has done. It also helps to get rid of the frustration of it all – and that’s far more in my case than his!
It concerns me that these suicidal/homicidal effects occur in very young children, as young as 4 years old.
Imaging how this effects adults?
This is why someone should invent something to see if a medication (s), is compatible for an individual.
If these asthma medications come with a ‘box warning’, parents or adults would make better informed decisions, before anyone is subjected to devastating psychiatric side effects.
If the USA have a ‘box warning’ for Singulair ( medication for asthma), why don’t the same standards apply for the Australian medication market?
Imagine, what other medications induce this psychological disturbance?
Sadly, many do not question whether the medication are inducing severe side effects because it is not highlighted in the patient information leaflet.
Yes, Rob, it is like playing a ‘game of Russian Roulette’ with one’s life and it is sad that Australia is just relying on pharmacists or doctors to highlight the potential side effects.
Under-reporting, does not acknowledge how many patients are suffering from severe side effects because it may be diagnosed as severe behavioural issues.
This reminds me of a medicine that nearly cost my life and if there was a ‘box warning’ on it and the Doctor had explained to me the potential side effects, the unnecessary pain and suffering, I had endured, would have been avoided. If only I knew……………………….!
Just need to get the awareness out there
Thank you for spreading awareness of the horrific, neuropsychological side effects of this drug. So many families have been affected and personally my child has been off of it for over 10 years, on it for 9 starting at age 7, and still suffers with anxiety and depression. Had I been presented all of the facts in a warning label or from her doctor or the pharmacist, prior to putting her on this, I would never have given it to her. Sadly, there isn’t an any research letting us know if/when all of the affected individuals will ever completely recover. Thank you again!
I am in my 50’s now and have had astma since i was 17 and have sufferd bad this year and been on steroids for 7 months of that year i was prescribed Montelukast 10mg it has only been a week but within 4 days of taking it i can breath better than i have in the last year on my packet it says not for under 15 year olds i know this is an old post and for some it sounds like it has horedus side effects but or me its the best medication i have ever used.