Popular asthma drug Singulair may be linked to mental health side effects, suicides: FDA

If you or someone you know is struggling with thoughts of suicide, you can call the US National Suicide Prevention Lifeline day or night on 988, or chatting online.

A new study into a drug that is widely prescribed asthma binds itself to receptors in the brain and is linked to serious mental health problems and suicide, according to new research.

The Food and Drug Administration presented preliminary results of a study of the asthma drug Singulair, sold generically as montelukast, to a “limited audience” at the meeting of the American College of Toxicology in Austin, Texas on November 20, according to Reuters. , which assessed the scientific presentation.

Laboratory tests showed “significant binding” of the drug to multiple brain receptors, according to Jessica Oliphant, deputy director of the FDA’s National Center for Toxicological Research. However, research does not show whether the binding leads to the harmful side effects of the drug.

Previous research also showed that the drugs entered the brains of rats.

However, more data is needed to confirm how the drug collects in the nervous system, the deputy director said.

Despite its findings, the FDA will not update the drug’s label based on the data presented.

USA TODAY has contacted the FDA for comment.

Brain receptors responsible for mood

The brain receptors that the drug binds to are involved in, but not limited to, the following, according to Reuters:

• Governing mood

• Impulse control

• Cognition

• Sleep

Research does not show whether the binding leads to harmful side effects of the drug, or who is at risk.

However, the drug “definitely does something that is worrying,” Julia Marschallinger, a scientist at the Austrian Institute for Molecular Regenerative Medicine, told Reuters.

When the FDA added a black box to the drug in 2020, it cited research by Marschallinger and Ludwig Aigner, another scientist from the same institute.

What is Singulair?

Singulair, originally sold by Merck & Co., is a prescription drug introduced in 1998 and used to prevent and treat symptoms of asthma and allergies, according to the Cleveland Clinicby “reducing inflammation in the airways, making it easier to breathe.”

Singulair comes in generic versions with the following names:

• Montelukast

• Montelukast Na

• Montelukast sodium

The brand-name and generic versions are prescribed to adults and children.

Early advertisements for the drug said it had benign side effects and compared it to a sugar pill, according to Reuters. But more than two decades later, the drug has been linked to mental health problems and episodes in patients prescribed it.

What are the side effects of Singulair?

The following are some of the side effects of the drug, according to the Cleveland Clinic:

Users may also experience sleep problems and vivid dreams or nightmares.

Anyone taking the medication and experiencing the side effects listed above should immediately report them to their healthcare team, according to the medical center.

Medication linked to dozens of suicides

In 2019, more than two decades after Singulair hit the market, thousands reported neuropsychiatric episodes after being prescribed the medication. Dozens of patients had also committed suicide.

“A wide variety of mental health adverse events have been reported,” said a statement published in 2022. “Including completed suicides.”

FDA Takes Regulatory Action

In October, the FDA said the drug poses serious risks or new safety information and that psychiatric disorders linked to the drug would require the agency to evaluate the “need for regulatory action.”

This isn’t the first time the drug has come under scrutiny by the FDA.

In 2020, the FDA announced that the drug a Boxed warningthe “most prominent warning”, about the “serious mental health side effects” of the drug, and recommended limiting its use to treat hay fever.

It already contained information about the risk of suicidal thoughts or actions, but some healthcare professionals and patients were unaware of the risk.

“We have determined that a stronger warning is necessary after conducting an extensive review of available information and convening a panel of outside experts,” the FDA said in a news release.

Contributions: Reuters.

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This article originally appeared on USA TODAY: Singulair may be linked to serious mental health side effects: FDA study