A new black box warning will be added to an asthma drug which has been linked to reports of three suicides in Australia during the past year.
The decision comes after more than a decade of lobbying by families about the dangerous potential side effects of the drug montelukast, marketed as Singulair.
The medication comes in chewable tablets and is commonly prescribed to children, but adults can also use it.
Some parents have said their children suffered severe side effects while taking the medication, including nightmares, behavioural changes, and in rare cases, suicidal thoughts.
An Australian mother living in the US, Mary Hozen, also told of how her 18-year-old daughter Sara took her own life after three month of taking montelukast.
The Therapeutic Goods Administration’s Advisory Committee on Medicines (ACM) approved the black box warning at a meeting in August, with the outcome published last week.
The decision follows similar moves overseas, where a black box warning has been added on products containing montelukast in the US, Canada and Europe.
In its meeting statement, the ACM said evidence for the potential association between montelukast and neuropsychiatric risks remained uncertain, but a black box warning would “align Australia with international regulators” and “acknowledge consumer concerns”.
Since then, the US Food and Drug Administration has released initial findings from internal research it has conducted into the effects of montelukast.
The results, presented at an American College of Toxicology conference last month, are yet to be peer-reviewed but showed montelukast attaches to multiple brain receptors critical to psychiatric functioning.
In Australia, there have been 20 “adverse events” involving medicines containing montelukast reported to the TGA in the last 12 months, including three suicides.
Anyone – including patients, doctors or family members – can report an adverse event. The reports have not been confirmed by the TGA and do not prove a causal link between a medicine and a side effect.
In the cases of all three people who ended their own lives, montelukast was the only drug they were known to be taking.
Back in 2018, following a series of articles published by 9news.com.au which told the stories of children and adults suffering from nightmares and suicidal ideations while taking the medication, the TGA announced information about possible neuropsychiatric side effects of montelukast would be added to product information inside the box.
Vanessa Sellick is a Melbourne mother who has been campaigning for warning labels on the drug’s packaging for 11-and-a-half years.
Sellick said the new black box warning was another step in the right direction, but the announcement had brought up a “mixture of emotions”.
“We’re excited by this progress, but, on the other hand, we know there’s been three additional suicides this year in Australia from montelukast-induced suicide, and that’s hard to accept,” she said.
“We’ve been advocating for 11-and-a-half years, and we’ve still got people dying from this medication.”
Sellick’s son Harrison, now 19, began taking Singulair at two years old.
He would have severe tantrums that would last for hours and when he was just four he began having suicidal thoughts, she said.
Sellick said her son was in the bath one day when he began begging her to kill him in graphic detail. At five, he made an attempt on his own life.
As a young adult, Harrison was still suffering the effects of the medication, Sellick said.
“One of the acknowledged side effects of (montelukast) is obsessive compulsive disorder, and that would probably be Harrison’s biggest struggle,” Sellick said.
“His OCD makes it difficult for him to function on a day-to-day basis. He still has anxiety, and he does suffer from bouts of depression as well.”
Sellick, who runs a patient advocacy group for people affected by montelukast along with another parent Jocelyn Suiter, said more needed to be done to help stop others suffering.
“What we want now is actually a fluorescent sticker on the outside of the packaging, which is called a cautionary advisory label,” Sellick said.
While warning labels on the outside of packaging could be found for some medications in Australia, such as those that should not be taken while operating heavy machinery, there were currently none for drugs associated with neuropsychiatric side effects, Sellick said.
Sellick and Suiter’s group have been working with the Pharmaceutical Society of Australia and the TGA, who have started a consultation process regarding a cautionary advisory label for montelukast.
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