Too many people prescribing and taking montelukast are unaware of its serious side effects. Neuropsychiatric events (NPE) can emerge suddenly or after chronic use. As explained by Dr Sally Seymour in this Medscape article, “Small children can’t report side effects, and young children or teenagers may experience changes in behavior or mood that can be mistakenly attributed to a normal phase of development.” Because there is no reason for parents, consumers and health professionals to assume an asthma medication can cause mental health problems, many only make this link when there is increased publicity about it.

Reports of neuropsychiatric events to the Therapeutic Goods Administration (TGA) bear this out. There is a direct correlation between publicity – such as TGA reviews into montelukast (2013 and 2018) and Australian media coverage of montelukast’s side effects – and reports to the TGA of such events. This is true down to the month of media coverage. For example, in September 2016, Australian media covered the issue on five occasions. Out of 70 reports made that year, 46 were made in September and 16 in October. In February 2018, the media covered it four times and 14 of 36 reports for that year were made in February. This is why we believe many people remain unaware that montelukast is causing their mental health issues and that adequate warnings about potential side effects must be given to everyone who takes this medication.

Montelukast side effects can be written off as behavioural or developmental difficulties in young children
The US Food and Drug Administration (FDA) Reports of Neuropsychiatric events linked to montelukast also show a pattern of peaks
which have been explained as related to publicity about them

In 2009, the US institute for Safe Medication Practices found, “Hundreds of doctors, parents and patients reported possible psychiatric side effects of montelukast, once informed of a possible connection. A handful of cases prior to March 2008 were credible enough for the manufacturer, Merck & Co., to include them in the product information for physicians, and to trigger an independent FDA safety review, without either indicating it had confirmed a causal relationship. The mere public notice that such a review had begun, together with the addition of suicide to the product label, was enough to trigger hundreds of additional case reports. For an event to be reported in a voluntary system, a linked series of events has to happen: 1) it has to occur; 2) it has to be observed in credible detail; 3) a connection to the drug has to be suspected, and 4) the observer must elect to report it. The case of montelukast illustrates what happens when one link in this chain—a connection to the drug—is largely missing, and what occurs when healthcare professionals and consumers are informed of a possible connection. In the past, drug manufacturers have sought to discount spikes in adverse event case reporting when connected to publicity as “stimulated” reporting, as if the cases were somehow less valid than other reports. We believe the opposite: without patients and doctors getting adequate information about possible drug adverse events, the injuries caused by drug therapy will be substantially underreported in any kind of monitoring system. Rather than discounting these events, such spikes are evidence of the system beginning to correct undercounting that routinely occurs … After the FDA warning, psychiatric side effects accounted for 96% of all types of adverse events cases reported; prior to the warning the warning psychiatric side effects accounted for 4% of a small number of cases.”

Sign and share the petition to insist Australian consumers are adequately warned about the potential mental health side effects of this drug.

If you or a loved one have experienced mental health side effects from montelukast, please report it to the TGA here.