December 3rd 2024.
A recent decision has been made to add a new black box warning to an asthma medication that has been linked to three suicides in Australia over the past year. This move comes after years of families advocating for awareness of the drug's potentially dangerous side effects. The medication, known as montelukast or Singulair, is often prescribed to children in chewable tablet form, but adults can also use it.
Concerns were raised by parents who noticed severe side effects in their children while taking the medication, including nightmares, changes in behavior, and in rare cases, suicidal thoughts. In fact, two adults who spoke to 9news.com.au shared that they either attempted to take their own lives or experienced serious episodes of self-harm while on montelukast. Another heartbreaking story was shared by Mary Hozen, an Australian mother living in the US, who lost her 18-year-old daughter Sara to suicide after just three months of taking the medication.
In August, the Therapeutic Goods Administration's Advisory Committee on Medicines met and approved the addition of a black box warning, which was published last week. This decision follows similar actions taken in other countries such as the US, Canada, and Europe. The committee acknowledged that there is still uncertainty surrounding the potential link between montelukast and neuropsychiatric risks, but they believed that adding the black box warning would align Australia with international regulators and address concerns raised by consumers.
The US Food and Drug Administration has also released initial findings from research on montelukast's effects on the brain. Although these results have not been peer-reviewed, they showed that the medication can attach to brain receptors that are crucial for psychiatric functioning. In Australia, there have been 20 reported "adverse events" associated with montelukast in the past year, including three suicides. These reports come from various sources such as patients, doctors, and family members, and have not yet been confirmed by the TGA.
All three individuals who took their own lives were known to be taking montelukast as their only medication. This is a concerning trend that was brought to light in 2018 when 9news.com.au published a series of articles featuring personal stories of individuals, both children and adults, suffering from nightmares and thoughts of suicide while taking the medication. As a result, the TGA announced that information about potential neuropsychiatric side effects would be included in the product information inside the box.
One mother, Vanessa Sellick, has been advocating for warning labels on montelukast's packaging for over 11 years. Her son Harrison, who started taking Singulair at just two years old, experienced severe tantrums and suicidal thoughts from a young age. As a young adult, he still struggles with obsessive-compulsive disorder, anxiety, and bouts of depression, all of which are recognized side effects of montelukast. Along with another parent, Jocelyn Suiter, Sellick runs a patient advocacy group and is calling for a fluorescent sticker on the outside of the packaging to serve as a cautionary advisory label.
Currently, there are warning labels on some medications in Australia, such as those that should not be taken while operating heavy machinery. However, there are no labels for drugs associated with neuropsychiatric side effects. Sellick and Suiter have been working with the Pharmaceutical Society of Australia and the TGA to establish a cautionary advisory label for montelukast. In the meantime, those seeking support can contact Lifeline or Beyond Blue for assistance.
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