For the past year, Martin Schmidt couldn't figure out why his six-year-old daughter Chloe stopped being a normal and happy girl.
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Asthma tablet caused 'monster' behaviour
Martin Schmidt speaks of his daughter Chloe, whose asthma medication Montelukast triggered unpredictable mood swings and extreme tantrums.
"She became extremely irrational, irate, moody .. it was like there was some imbalance in her brain, just setting off this little monster that we knew wasn't our daughter," Mr Schmidt, a Wollongong teacher, said.
Earlier this month he learned that Chloe's asthma medication Montelukast - a chewable, cherry-flavoured tablet - could trigger suicidal thoughts and actions, depression and aggressive behaviour.
He immediately stopped the medication and, in his words, he got his daughter back.
The Schmidts are among 91 affected Australian families who are demanding a fluorescent warning label about the side effects be added to the packaging of medications with the active ingredient Montelukast, including the popular, brand-name version Singulair.
The families claim their doctors and pharmacists never warned them of the possible neuropsychiatric side effects. There are no warnings on the box or on an information leaflet inside.
In the US, drug makers were ordered to include warnings in the box after a 15-year-old boy named Cody Miller, who had taken the medication for 17 days, committed suicide.
The Therapeutic Goods Administration has received 119 reports of "psychiatric events" linked to seven medicines with Montelukast between 2000 and June 2016. It says warnings are not necessary and it will consider "further activities" to highlight the issue.
After sharing her son's experience in an ABC 7.30 story about Singulair in early September, Vanessa Sellick from Melbourne launched a Change.org petition demanding compulsory labelling that has since gained 1500 signatures.
Her son Harrison began taking Singulair when he was two years old. He lost control over his emotions and had frequent meltdowns. When he was four, he expressed suicidal thoughts and at age five he acted on them.
"One night during bath time he asked me to break both of his legs so that he would fall to the bottom of the bath and drown. I was horrified, heartbroken, scared and confused," said Ms Sellick.
"During one of his medical assessments he stated to the doctor: 'I feel like there's nothing in my body, I'm just breathing without lungs, blood just pumping without a heart'."
The Consumer Health Forum said adding a warning label was only one part of the solution.
"The most important point is that doctors and pharmacists have the prime responsibility for informing patients and/or parents all they need to know about the medicine," said its chief executive Leanne Wells. "Labelling is part of that advice."
MSD, an arm of American pharmaceutical company Merck & Co., said it was confident in the efficacy and safety of Singulair, a medication that has been prescribed to tens of millions of patients.
It said the side effects were outlined in the 'Product Information' and 'Consumer Medicine Information' leaflets that were available online. The weblink was printed on the box.
"The decision to prescribe or to discontinue treatment is taken jointly by the doctor and their individual patient, as only they can weigh-up the potential benefits against any potential risks in a given individual case," a spokesman said.
"The doctor has a responsibility to keep themselves up-to-date with the effects of that medicine."
Dr Richard Kidd, Australian Medical Association's chair of general practice, has previously said the chance of side effects was too low to warrant unnecessarily frightening parents.
Professor Greg Kyle, a pharmacy expert at Queensland University of Technology, said 16 Singulair cases that have been reported to the TGA were related to suicidal thoughts and depression.
"So 16 cases in over 2 million prescriptions makes this a truly rare effect," he said. "Ideally, these effects would not occur. However, expecting such rare events to be included on warnings is not feasible."
Both the National Asthma Council and Asthma Australia have dismissed the calls from parents for a warning label, saying Montelukast was highly effective and had an "excellent" safety record.
"Asthma Australia and our partners the National Asthma Council Australia will continue to monitor and assess evidence and update parents and the wider community as necessary," a statement said.
For Mr Schmidt, a warning label is one part of the solution.
"I wouldn't point the blame at one particular person or group. I think there has to be overall more awareness of the issue, and for doctors to warn their patients," he said.
"It's amazing, my wife and I look at Chloe now and just think bliss. The tantrums are gone, the feelings of guilt are gone, she's so much more engaged in having cuddles, being happy and loving," he said.
Ms Sellick said she would not stop fighting for compulsory warning labels and urged parents who suspect side effects in their children to consult their doctor.
The TGA said: "Patients and their carers are encouraged to report adverse events to the TGA. Adverse event reports help inform our regulatory and educational activities."