FDA Requires Stronger Warnings on Singulair and Generic Montelukast

On March 4, 2020 the U.S. Food and Drug Administration (FDA) announced it would be strengthening the warning regarding the risk for neuropsychiatric events related to the drug Montelukast, marketed both as Singular® and in generic form. A boxed warning, the most visible warning label the FDA uses, will be issued. Those who are prescribed Montelukast will also be given a new patient medication guide to educate about the drug and the risks associated with it.^1-3

Prescribing information for Montelukast

Montelukast is frequently prescribed in the management of asthma and allergic rhinitis (hay fever) symptoms. With the new warning, doctors are encouraged to prescribe alternate treatments, particularly for those with mild cases of hay fever. Other drugs should be tried and deemed ineffective for an individual before prescribing montelukast.

For those using Montelukast to treat asthma, a detailed discussion weighing the risks and benefits to the individual should be undertaken between the prescribing physician and the individual. While Montelukast does already contain a mental health risk warning, the FDA is concerned that those being prescribed Montelukast are unaware of the potential mental health side effects. Therefore, the stronger, boxed warning is being used going forward.^1-3

Neuropsychiatric events

The FDA is concerned with the increased rate of neuropsychiatric events as evaluated in their most recent data findings. Some of the neuropsychiatric events that have been reported with montelukast include depression, agitation, sleeping problems, and suicidal thoughts and actions. The FDA updated the label to reflect these concerns in 2008 when these neuropsychiatric events began to be reported.

As continued reports of suicide and mental health side effects from Montelukast were referred through the FDA Adverse Event Reporting System (FAERS), the FDA undertook a further evaluation of the drug, resulting in the announcement of the new warning label.^1-3

Information about Montelukast

Montelukast was first approved and brought to the market in 1998. It is available in tablet, chewable tablet, and oral granule forms. Montelukast is approved and prescribed to individuals of all ages, including children as young as six months for indoor allergies. Of the nearly 9.3 million people who are prescribed Montelukast, around one quarter are under the age of 17.

Montelukast works by blocking a substance called leukotrienes which helps to manage asthma and hay fever symptoms. Leukotrienes send signals to increase the swelling and tightening in the airways. Montelukast is designed to block those signals from being passed along to the body.^1-3

Montelukast side effects

If you have noticed any mental health changes either in yourself or your child and you suspect montelukast could be the reason, you are urged to reach out to your physician immediately to discuss whether this drug should be continued or stopped. Any individual or prescribing physician who notices side effects from Montelukast is encouraged to report their response to the FDA MedWatch program.

There are many alternate over-the-counter drugs that have proven to be effective in treating mild hay fever for most people without the mental health side effect risks that come with Montelukast. Some of these options are Alavert®, Claritin®, Allegra®, Zyrtec®, and Benadryl®. You should discuss any drug that might be a good alternative for you with your doctor before making a switch.^1-4

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