Singulair may be linked to severe mental health side effects: FDA study
If you or someone you know is struggling with suicidal thoughts, you can call the U.S. National Suicide Prevention Lifeline at 988 any time day or night, or chat online.
A new study on a drug widely prescribed for asthma is binding itself to receptors in the brain and is linked to severe mental health issues and suicide, according to new research.
The Food and Drug Administration presented the preliminary results of a study on the asthma drug Singulair, which is sold generically as montelukast, to a “limited audience” at the American College of Toxicology meeting in Austin, Texas on Nov. 20, according to Reuters, which reviewed the scientific presentation.
Lab tests showed “significant binding” of the drug to multiple brain receptors, according to Jessica Oliphant, a deputy director at FDA’s National Center for Toxicological Research. However, research does not show whether the binding leads to the harmful side effects from the drug.
Earlier research also found that the medications penetrated the brains of rats.
However, more data is needed to confirm how the drug collects in the nervous system, according to the deputy director.
Despite its findings, the FDA will not update the drug’s label based on the presented data.
USA TODAY has reached out to the FDA for comment.
Brain receptors in charge of mood
The brain receptors that the drug is binding to are involved in, but are 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 from the drug, or who is at risk.
However, the medication is “definitely doing something that’s concerning,” Julia Marschallinger, a scientist at Austria’s Institute of Molecular Regenerative Medicine, told Reuters.
When the FDA added a black box to the drug in 2020, it cited research from Marschallinger and Ludwig Aigner, another scientist from the same institute.
What is Singulair?
Singulair, originally sold by Merck & Co., is a prescription drug that was launched in 1998 and is used to prevent and treat symptoms of asthma and allergies, according to the Cleveland Clinic, by “decreasing inflammation in the airways, making it easier to breathe.”
Singulair comes in generic versions with the following names:
- Montelukast
- Montelukast Na
- Montelukast sodium
The name-brand and generic versions are prescribed to adults and children.
Early advertisements for the drug stated it had benign side effects and compared to a sugar pill, according to Reuters. But, over two decades later, the drug has been linked to mental health issues and episodes in patients to whom it is prescribed.
What are the side effects of Singulair?
The following are some of the side effects of the drug, according to the Cleveland Clinic:
- Anxiety
- Nervousness
- Confusion
- Hallucinations
- Irritability
- Hostility
- Thoughts of suicide or self-harm
- Worsening mood
- Depression
Users can also experience trouble sleeping and vivid dreams or nightmares.
Anyone who is taking the medication and experiencing the side effects listed above should report them to their healthcare team immediately, according to the medical center.
Medication linked to dozens of suicides
In 2019, over 20 years after Singulair hit the market, thousands reported having neuropsychiatric episodes after being prescribed the medication. Dozens of patients had also committed suicide.
“A wide variety of mental health side effects have been reported,” according to a statement published in 2022. “Including completed suicides.”
FDA takes regulatory action
In October, the FDA listed the drug as having 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 is not the first time the drug has been place under scrutiny by the FDA.
In 2020, the FDA announced the medication would require a Boxed Warning, its “most prominent warning,” about the drug’s “serious mental health side effects” and advised restricting its use to treat hay fever.
It had already included information regarding the risk of suicidal thoughts or actions, but some health care professionals and patients did not know of the risk.
“We decided a stronger warning is needed after conducting an extensive review of available information and convening a panel of outside experts,” the FDA stated in a release.
Contributing: Reuters.
Julia is a trending reporter for USA TODAY. You can connect with her on LinkedIn, follow her on X, formerly known as Twitter, Instagram and TikTok: @juliamariegz, or email her at [email protected]
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