FDA issues a warning over mental health risks of asthma medication

The FDA has released a new warning after research found evidence of a link between widely used asthma medication to severe psychological episodes, including suicidal thoughts. 

Concerns about the medication, Montelukast (commonly known as Singulair), first emerged four years ago during the COVID-19 pandemic but received little attention in the media. So far, many healthcare professionals and patients remained unaware of the risks.

Now, New York Attorney General Letitia James has urged the FDA to revisit the issue, as nearly four years have passed since the FDA initially looked at the issue. 

She said: “Since that decision in March 2020, the prevalence of tragic adverse mental health events, including aggression, depression and suicide, continue to be widely reported, and disproportionately so for pediatric patients. 

Of the estimated 12 million people prescribed the medication, an estimated 1.6 million are children. … Parents and guardians have the right to be fully informed of a medication’s potential side effects when making choices about their children’s health. The risks associated with taking Singulair are far too dire to come without a very clear warning.”

The FDA initially issued the warning after reviewing evidence of mental health side effects associated with Montelukast/Singulair. 

These side effects include not only suicidal thoughts but also behaviour changes, agitation/aggression, depression, and sleep disorders, particularly among seniors. The FDA also highlighted that these issues may persist even after discontinuing the medication.

The UK’s regulatory agency, the Medicines and Healthcare Products Regulatory Agency (MHRA), has now raised its own concerns. Data from the MHRA’s 2023 Yellow Card reports the highest-ever number of 143 reports of psychiatric disorders linked to Montelukast.

In a drug safety update, the MHRA advised prescribers to carefully evaluate the benefits and risks of continuing treatment if neuropsychiatric reactions occur.

According to Drugwatch.com, alternative medications for asthma and allergy treatment for anyone worried about this include Advair, Allegra, Claritin, Flonase, Loratadine, Prednisone, Promethazine, Symbicort, Xolair, and Zyrtec. However, it’s advised to speak to a doctor. 

 Drugwatch recommends: “Speak with your healthcare provider to explore your treatment options. To ensure safe and effective management of your symptoms, always consult your doctor before discontinuing Singulair or starting a new medication.”