Parents of children affected by the popular asthma medication Singulair have spoken out about what they believe are the long-term side effects of the drug, with several saying they fear the psychological damage done to their children could be permanent.
Singulair, also known by its generic name montelukast, is commonly prescribed to children suffering asthma because of its pleasant-tasting, chewable tablets.
But the drug has been linked to psychotic breakdowns in children and its listed side effects include nightmares, increased aggression, suicidal thoughts and depression.
In 2015, the TGA issued a notice to doctors reminding them of the side affects of the drug, which it says are extremely rare.
In the past five years to October 2017, the TGA received 227 reports of adverse psychiatric events from Australian patients being treated with the drug.‘NO-ONE TOLD ME THERE WAS A RISK’According to an Asthma Australia fact sheet on Singulair, the side effects of the drug “are reversible once the medication is ceased”.
However, Sunshine Coast mum, Wendy Lawrence, said she believed the drug triggered a mental health condition in her son that he is yet to recover from.
Ms Lawrence’s son, who is now 20 years old, took the medication for 10 years from the age of five.
“Everything started to go wrong when he was on that medication and it continued to get worse while he was on it,” she said.
“No-one ever told me that there was any risk. Maybe I’m an idiot and I needed to do more research, but who would connect an asthma medication to things like that?
”Ms Lawrence said her son’s behaviour problems started soon after he went on Singulair, and by the age of six he had been diagnosed with ADHD as was seeing a psychiatrist once a fortnight.“Normally the ADHD medication would calm things down, but it didn’t do anything for him,” she said.
Ms Lawrence’s son’s behaviour problems worsened over the years, as did his mental health.“By the end of primary school he began self harming – cutting himself with razor blades. Eventually covering himself with thick scars on his arms, legs, stomach, ribs and neck,” she said.
Ms Lawrence said she never made a connection between Singulair and her son’s worsening mental health, and only stopped the medication when he was 15 because doctors told her at the time there was no adult version to give him.
By the time her son stopped the medication he had also developed a drug problem which continued to exacerbate his mental health, she said.
Ms Lawrence acknowledged she had no evidence her son’s problems all stemmed from Singulair but she was convinced the drug played a significant part.“Maybe all of his issues don’t trace back to Singulair, but it seems highly probable that many of them might.”
“If I had of known there was a chance it could cause him to feel suicidal and depressed I would never have let him be on it, because I know that sort of stuff runs in my family anyway.”
“It’s shocking that the drug has been out for so long, and especially with children taking it for so long and having these horrible side effects and no one has done anything.”
DRUG TRIGGERED DAUGHTER’S BREAKDOWN, MUM SAYSNSW mum Emma, who did not want her surname used, said her 11-year-old daughter became suicidal after taking Singulair for four months and was still suffering severe mental health issues almost three years later.
Before taking Singulair, Emma said her daughter had no mental health issues.
“Our daughter went from being the most caring, loving girl who loved sport and her friends to being catatonic then begging us, at one stage, to help her end her life,” she said.
When Emma informed her daughter’s paediatrician and GP about the dramatic changes in her daughter’s behaviour since starting Singulair, she was told to take her off the medication immediately.
However, Emma said her daughter’s mental health continued to worsen, even after she stopped taking the medication.
“I can’t even begin to tell you about her journey from then until now as so much has happened, including suicide attempts, self-harm, several emergency admissions,” she said.
“We were in no way informed about the possible side effects by either the paediatrician nor the pharmacies which filled the scripts for us. We have also been lead to believe that “this was always going to happen” and “it’s not the medication”
.However, Emma said she believed her daughter’s condition was triggered by Singulair.Another mother, Caroline Cornford, from Brisbane, said her son Tim, now five, was prescribed Singulair when he was two-and-a-half.
“After a few months of being on it his behaviour changed dramatically. He would have these scary night terrors which would last for hours. It was like he was possessed by a demon. He was aggressive and sad all of the time,” Ms Cornford said.
Ms Cornford said it was her mother who finally connected the drug to his behaviour after researching online.
“After more research we stopped Singular immediately. His aggression and night terrors subsided gradually,” she said.
However, Ms Cornford said she feared her son may never recover fully from all the drug’s effects.“I think the damage had already been done. He has had speech and delayed development problems and was officially diagnosed with autism last year.
“I think Singulair was a contributing factor, before he was on it he was reaching all of his language and developmental milestones. He was happy little boy.”
“PEOPLE BELIEVE IT’S MAKING CHANGES IN CHILDREN’S BRAINS”
Melbourne mother Vanessa Sellick, has been campaigning for warning labels on the drug’s packaging since 2016, when she went public with the story of her son Harrison, who tried to take his own life at the age of four while he was withdrawing from the medication.
Ms Sellick also helps run a Facebook awareness group about the side effects of Singulair, which has 4000 members.
The group recently surveyed 390 of its members affected by Singulair, and found that more than 60 percent, or 241, reported lingering side effects.The most common lingering side effects were anxiety, ADHD and OCD (obsessive compulsive disorder).
Ms Sellick said Harrison was now doing well, almost eight years after stopping the medication, but still had ongoing OCD issues.
While many kids seemed to bounce back immediately after stopping the drug, this was not always the case,
Ms Sellick said.Ms Sellick said as well as her son’s experience, there was anecdotal evidence from her group’s members that the effects of the drugs could linger in some children for years.
“People believe that it is making changes in their children’s brains,” she said.“With the long-term effects, we are hearing that it affects their schooling and it affects their concentration.
“It seems to be the longer you have been on the medication the longer the effects can linger.”
RESEARCH ON LONG-TERM AFFECTS NEEDED
A study by Dutch researchers last September found kids taking Singulair were 20 times more likely to have suicidal thoughts and 30 times more likely to show aggressive behaviour.
However, none of the studies on Singulair and montelukast’s effects have so far looked at the drug’s long term effects.
Royal Australian College of GPs president and National Asthma Council director Bastian Seidel said if parents were reporting long term effects from the drug then more research needed to be done to investigate the claims.
“It certainly would be concerning if that was the case. Realistically if we have more parents, more patients coming forward and saying this is how the medication has affected me, then I think it does warrant a scientific investigation of whether those claims can be validated.”
“I think we need to be careful that scaremongering isn’t taking place. But again we need to thoroughly appraise the medication, particularly when people are talking about irreversible and long term side effects.”
Dr Seidel said Singulair was often used as a last resort option for patients whose asthma could not be controlled by other medications and could be life-saving for severe asthma sufferers.
“It is a drug that works well for quite a few patients who have tried everything else. For them it’s literally a lifesaver. No doubt about it, from some patients it’s a complete game changer,” he said.“But for some there are adverse reactions and we should take them very seriously and really discuss with parents what are the benefits and potential negative reactions to the drug.”
Dr Seidel said, like the TGA, the National Asthma Council’s scientific review committee was looking into the adequacy of the warnings received by patients and parents “as we speak” after being alerted to the concerns in nine.com.au’s reports last week.
REPORTED CASES COULD BE ‘TIP OF THE ICEBERG’Doctors have stressed the common usage of the drug, and that the number of adverse psychiatric events recorded with the TGA only number in the hundreds, to emphasise how safe it is.
However, a NSW doctor, whose eight-year-old daughter became suicidal while taking the drug, said severe side effects appeared to be far more common than first thought and the number of reported cases could be the “tip of the iceberg”.
“It is becoming increasingly obvious that these side-effects are not as rare as health professionals and pharmaceutical companies have previously thought,” he said.
“Unless you follow-up specifically on every one of the 2 million prescriptions in Australia for Singulair, you cannot accurately report on the incidence of these side effects.”
Dr Seidel said he shared concerns the number of patients experiencing Singulair side effects could be underreported.
“Often it’s not reported, and this is my concern as well. So I think that’s why we should take the view of parents and patients very seriously and we have got to make sure that their concerns about adverse reactions are recorded appropriately,”
Dr Seidel said.Dr Seidel said he was also concerned that in some cases Singulair was being prescribed by specialists in hospital without a follow-up from GPs.
“It is often not the GP who is prescribing the medication. It’s often a specialist. So what we assume, and this is based off case anecdotes, is often there isn’t much time, the doctor is just prescribing something and here we go, the parent will think if the specialist prescribed it, I must be taking this no matter what,” he said.“
And often there is no follow up appointment made to see the GP to monitor what the positive and negative side effects are.”