Why would a standard 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, corresponding to suicidal thoughts and signs of depression. The latest warnings are required to be printed initially of data 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 the event you or a member of the family uses montelukast? Here's what you might want to know.

First, what's montelukast?

Montelukast is a prescription drug that can also 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 vital 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 corresponding 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 latest 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 brought on by 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 the way it happens. one Assumption This is since the drug and its breakdown products (or metabolites) affect the brain's chemistry.

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

Why is the TGA making this variation 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 scale back drug risk in the sunshine of current international recommendations.

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

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