Why a common asthma drug will now carry extra safety warnings about depression

Extra Warnings Issued for Asthma and Hay Fever Drug Montelukast

Australia’s Therapeutic Goods Administration (TGA) recently issued a safety alert requiring extra warnings to be included with the asthma and hay fever drug montelukast.

What is Montelukast?

Montelukast is a prescription drug also known by its brand names which include Asthakast, Lukafast, Montelair and Singulair. It’s used to manage the symptoms of mild-to-moderate asthma and seasonal hay fever in children and adults.

What is the Link to Depression and Suicide?

The possibility that this drug may cause behavioural changes is not new information. Manufacturers knew this as early as 2007 and issued warnings for possible side-effects including depression, suicidality and anxiousness.

The United Kingdom’s Medicines and Healthcare products Regulatory Agency has required a warning since 2008 but mandated a more detailed warning in 2019. The United States’ Food and Drug Administration has required boxed warnings for the drug since 2020.

Montelukast is known to potentially induce a number of behaviour and mood changes including agitation, anxiety, depression, irritability, obsessive-compulsive symptoms, and suicidal thoughts and actions.

Recent Study Findings

A recent study published in November 2024 examined data from more than 100,000 children aged 3–17 with asthma or hay fever who either took montelukast or used only inhaled corticosteroids.

It found montelukast use was associated with a 32% higher incidence of behavioural changes. The behaviour change with the strongest association was sleep disturbance, but montelukast use was also linked to increases in anxiety and mood disorders.

Why is the TGA Making this Change Now?

The new risk warning requirement comes from a meeting of the Australian Advisory Committee on Medicines where they were asked to provide advice on ways to minimise the risk for the drug given current international recommendations.

Even though the 2024 review didn’t highlight any new risks, to align with international recommendations, and help address consumer concerns, the advisory committee recommended a boxed warning be added to drug information sheets.

Conclusion

Montelukast is a widely used medication for asthma and hay fever, but it does carry a risk of behavioural changes, including depression and suicidal thoughts. The new warnings are an important step in ensuring patients and healthcare providers are aware of these risks and can take steps to mitigate them.

FAQs

Q: What is montelukast used for?

A: Montelukast is used to manage the symptoms of mild-to-moderate asthma and seasonal hay fever in children and adults.

Q: What are the potential side-effects of montelukast?

A: Montelukast may cause behaviour and mood changes, including agitation, anxiety, depression, irritability, obsessive-compulsive symptoms, and suicidal thoughts and actions.

Q: Should I stop taking montelukast if I have concerns?

A: No, you should not stop taking montelukast without consulting your doctor. They can discuss the risks and benefits of the medication with you and, if appropriate, prescribe a different medication.

Q: Where can I get more information about montelukast?

A: You can speak to your doctor or pharmacist for more information about montelukast. You can also visit the TGA website for more information on the drug and its safety.