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Alan Khadavi, MD, APC
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August 10, 2023 by Alan Khadavi

Is Singulair Safe to Use? A study of Montelukast

Is Singulair safe to use?

Montelukast is a selective leukotriene receptor antagonist recommended for the treatment of asthma and allergic rhintis. During the recent decade, concerns have been raised regarding potential neuropsychiatric adverse events in patients initiated on Singulair. In 2020 the US FDA issued a warning of serious mental health side effects for Singulair. However, earlier studies have been conflicting because of small sample sizes and cofounding factors.

Singulair psychiatric side effects; a large study

A recent nationwide cohort explored the association of the use of of Singulair and onset of neuropsychiatric disorders in individuals 18 years and older with asthma.

The researchers concluded that the initiation of Singulair was significantly associated with the use of neuropsychiatric medicine including antidepressants, antipsychotics, anxiolytics, lithium and medication used for attention deficit/hyperactivity disorder.  In the study, age significantly played a role with an increased risk in age groups 18-44 years, where as no association was seen among patients 45 years or older. This was consistent with other studies.

There are however other studies that have contradicted these findings.

Overall it was concluded that Singulair in adult patients with asthma was associated with a substantial an increased risk of neuropsychiatric events compared with those on other asthma medications. The association was strongest in the the youngest age groups.

Doctors and patients need to be aware of such potentially serious adverse effects of Singulair.

Most patients who take Singulair will not experience these adverse effects, but patients and doctors need to be aware of the possibility of it that it will occur. Even more so in patients that have a history of depression or other psychological disorders. This study did not look into children under 18 years of age, but the FDA has already had warnings about this saying that risks may include suicidal thoughts and actions.

FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis

The vast majority of patients, Singulair is safe to use. If you are currently on Singulair or you are considering taking it, speak to your doctor about the potential risks and benefits and see if its right for you. An alternative medication to Singulair is Zafirlukast (Accolate), which has a similar mechanism of action. Unfortunately Zafirlukast has its own list of potential side effects and it much less commonly used. Patients on Zafirlukast also require lab monitoring of their liver enzymes regularly.

 

Filed Under: Blog, Headlines

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Dr. Alan Khadavi
Allergy & Asthma Specialist

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