Asthma drug Singulair linked to negative mental side effects

The Food and Drug Administration (FDA) issued a warning to a commonly prescribed asthma medication in 2020 — but millions are still taking it.

A black box warning, also called a boxed warning, was issued by the FDA in March 2020 about the mental health side effects of Singulair, also known by its generic name, montelukast — a 25-year-old asthma and allergy drug.

Boxed warnings are the highest safety-related warnings that medications can have assigned by the FDA, according to the National Institutes of Health (NIH).

The warning addressed decades of escalating concerns over aggression, agitation and even suicidal thoughts. The FDA flagged it to physician’s groups but didn’t require doctors to be educated on the drug’s side effects.

And while the warning was issued primarily for doctors who prescribe the medication to relay the information to their patients, it seems very few were actually told.

Despite the grim warning, 12 million people in the United States, including 1.6 million children, were still prescribed the drug in 2022, the New York Times reports.

Experts emphasized that children are particularly vulnerable to the side effects.

The outlet obtained data from healthcare analysis company Komodo Health based on claims submitted to Medicaid and Medicare as well as claims submitted to private insurers.

Singulair’s manufacturer, Merck & Co., transitioned some of its products to Organon, including Singular (monelukast sodium), in June 2021.

“Nothing is more important to Organon than the safety of our medicines and the people who use them. Reports of adverse events are taken seriously and, as with all of our medicines, we continually monitor the safety of SINGULAIR,” Organon said in a statement to The Post.

“We remain confident in the efficacy and safety profile of SINGULAIR when used in accordance with the FDA-approved Prescribing Information. The product label for SINGULAIR contains appropriate information regarding SINGULAIR’s benefits, risks and reported adverse reactions.”

“Organon is confident that it has communicated to health care providers and patients complete and appropriate information regarding SINGULAIR for the safe and effective use of the medicine in line with the prescribing information,” the rep added, noting patients should discuss concerns with their health care provider.

The fact that the drug is still prescribed at high levels despite the rise of reports from affected patients raises concerns over whether the warning even reached enough doctors and patients, who often don’t read the fine print on the drug’s label.

One woman, Nicole Sims, turned to the internet for answers when her 6-year-old son started having nightmares and hallucinations of a woman in the window and told her that he wanted to die, the Times reported. She claimed her internet searches were the first time she heard of the FDA warning.

Sims also stumbled upon a Facebook support group — called the Montelukast (Singulair) Side Effects Support and Discussion Group — with over 20,000 members who share their experiences about the side effects of the medication.

The members discovered a link of their side effects to the drug with the help of their peers — not their doctors.

“It’s a mental health crisis that nobody is recognizing,” Anna Maria Rosenberg, an administrator of the group, told the Times.

Dr. Reshma Ramachandran, a Yale University assistant professor and family doctor, is concerned that not enough doctors know about the warning, telling the outlet that it hasn’t gotten through to channels that doctors will notice.

Ramachandran added that the FDA “needs to do much more in terms of direct communication to clinicians and through more active channels.”