Why would a typical asthma drug now carry additional safety warnings about depression?

Australia's Therapeutic Goods Administration (TGA) recently issued a security warning requiring Additional warnings Asthma and hay fever medicine needs to be added with montelukast.

Warnings are for consumers and their families to search for serious behavioral and mood changes, comparable to suicidal thoughts and signs of depression. The recent warnings are required to be printed at the start of knowledge leaflets given to each patients and health care providers (sometimes called “boxed” warnings).

So why did the TGA issue this warning? And is there any cause for concern in case you or a member of the family uses montelukast? Here's what it’s good to know.

First, what’s montelukast?

Montelukast is a prescription drug that can be known by its brand names including Asthakast, Lukafast, Montelair and Singulair. It is used to administer the symptoms of mild to moderate asthma and seasonal hay fever Children and adults.

Asthma occurs when Airways tight and produces extra mucus, which makes it harder for air to maneuver into the lungs. Likewise, a runny nose is characteristic Tuberculosis Caused by excess production of mucus.

Leukotrienes is a crucial family of chemicals present in the airways and involved in each mucus production and airway obstruction. Montelukast is a cysteinyl leukotriene receptor antagonist, meaning it blocks the location within the airways where leukotrienes act.

Montelukast can’t be used to treat severe asthma (asthma attack), since the tablet takes time to interrupt down within the stomach and be absorbed into the body. Rather, it’s taken each day to assist prevent asthma symptoms or seasonal hay fever.

It will be used with asthma puffers containing corticosteroids and medications comparable to salbutamol (Ventolin) in severe attacks.

What is the connection between depression and suicide?

The possibility that this drug may cause behavioral changes shouldn’t be recent information. The manufacturers knew this. In early 2007 and issued warnings for possible unwanted effects including depression, suicidality and anxiety.

The UK Medicines and Healthcare Products Regulatory Agency requires a warning. Since 2008 But a more detailed warning is warranted. In 2019. Required by the United States Food and Drug Administration. Boxed warnings For drugs from 2020.

Montelukast is thought to potentially induce numerous Changes in behavior and moodincluding agitation, anxiety, depression, irritability, obsessive-compulsive symptoms, and suicidal thoughts and actions.

Initially one A 2009 study It analyzed data from 157 clinical trials involving greater than 20,000 patients and concluded that there have been no outright suicides attributable to taking the drug, and only a rare risk of suicidal thoughts or attempts.

Most of all A recent studyPublished in November 2024, it reviewed data from greater than 100,000 children aged 3–17 years with asthma or hay fever who received either montelukast or inhaled corticosteroids alone. .

It found that montelukast use was related to a 32 percent higher incidence of behavioral changes. The behavior change with the strongest association was sleep disturbance, but montelukast use was also related to a rise in anxiety and mood disorders.

Over the past ten years, there have been roughly 200 cases of behavioral unwanted effects. Reported to TGA. In relation to montelukast. This included 57 cases of depression, 60 cases of suicidal thoughts and 17 cases of suicide attempts or deliberate self-harm. There were seven cases where patients taking the drug accomplished suicide.

This is definitely sad. But these numbers have to be seen within the context of the number of individuals shooting up. During the identical time, Over 200,000 scripts For montelukast are covered under the Pharmaceutical Benefit Scheme.

Overall, we don't know definitively that montelukast causes depression and suicide, just that it seems to extend the chance for some people.

And if it does change behavior, we don't fully understand how. one Assumption This is since the drug and its breakdown products (or metabolites) affect the brain's chemistry.

In particular, it may possibly interfere with how the brain detoxifies the antioxidant glutathione or alter the regulation of other brain chemicals, comparable to neurotransmitters.

Why is the TGA making this transformation now?

The threat warning comes from meeting the brand new requirement. Australian Advisory Committee on Medicines where they were asked to offer advice on ways to cut back drug risk in the sunshine of current international recommendations.

Although the 2024 review didn’t highlight any recent risks to align with international recommendations and help address consumer concerns, the advisory committee beneficial adding boxed warnings to drug information sheets. .

If you might have asthma and take montelukast (or your child does), it’s best to not only stop taking the medication, as this might put you vulnerable to an attack that will be life-threatening. . If you might be concerned, seek advice from your doctor who can discuss the risks and advantages of medicines for you, and, if appropriate, prescribe a special medication.