Concerns raised over common asthma drug

A pharmacy technician fills a dispensing machine with Montelukast (Getty)

A pharmacy technician fills a dispensing machine with Montelukast Source: Getty / George Frey

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A common childhood asthma drug has been linked to three suicides in Australia and hundreds of other medical episodes. Concerned parents are calling on the Australian pharmaceutical regulator to follow Europe and the United States, and add a ‘box warning’ to the medication.


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Asthma is a health issue that affects almost three million Australians.

Nearly half a million of those are under the age 15.

Professor Bandana Saini from the University of Sydney says its causes can vary.

“It's actually caused by inflammation. And that can happen as a result of exposure to allergens, but there might be actually much more bigger causes, for example, our environments and how our genes interact in responding to our environments. So it's very complex to describe what causes it, but what happens in asthma is an inflammation or an inflammatory process inside the of the lungs.”

One in three people with asthma uses medication daily, one of them being Montelukast, more commonly known by its generic name Singulair.

It is usually prescribed when asthma is mild and can stop it from getting worse.

The medication has been linked to psychotic episodes in some children, including nightmares, depression and suicidal thoughts.

This has led to new calls for warning labels to be included on its packaging, a measure already adopted by countries such as the US and others in Europe.

Professor Saini says that the appeal is valid, but specialists should not stop prescribing the drug.

“While it is a very rare effect, having these box warnings on medications can alert consumers. The idea is not that the drug that shouldn't be use. It's very effective, reasonable safe, particularly useful in children.”

Montelukast is listed on the Pharmaceutical Benefits Scheme for children under 14.

In the last financial year, over a hundred thousand prescriptions were handed out for the drug.

The drug first came on the market in 1998.

Since then, the Therapeutic Goods Association - which regulates medicines - has received more than 300 reports of psychiatric disorders, including four deaths.

Even so, Montelukast remains popular with parents, mainly because it comes in tablet form, which makes it easy for children to use.

Still, Peter Wark from the National Asthma Council of Australia says he prefers to encourage the use of inhalers.

"There's a perception that using a tablet is easier than using an inhaler, however, none of these things are really the case. Inhaled steroid should be used in a majority of people with asthma from the age of 6 onwards, they have been shown to be both very safe and highly effective. And of course inhalers can be used in children of almost all ages through the use or the space of device to assist with their use.”

The TGA last reviewed the safety of Montelukast in 2018 and, while it says it will not follow the US and Europe for now, it is committed to closely monitoring the problem and take regulatory action if necessary.

Professor Saini says Australia should continue monitoring evidence, but that most people can feel safe using the medicine.

“Should those symptoms occur, they should really come back and talk to their prescriber, their GP or their respiratory physician and get an alternative medication prescribed. I think there's a balance issue here where there's risks related to the drug, but there's also immense benefits. And we should keep that balance in mind.”

 


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