Singulair may be associated with serious mental health effects: FDA study
If you or someone you know is struggling with suicidal thoughts, you can call the US National Suicide Prevention Lifeline at 988 any time of the day or night, or chat online.
A new study on a widely prescribed drug for asthma binds 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 the first results of a study on the asthma drug Singulair, sold generically as montelukast, to a “limited audience” at a meeting of the American College of Toxicology in Austin, Texas on Nov. 20, according to Reuters, which reviewed the scientific presentation.
Lab tests showed the drug’s “significant binding” to multiple receptors in the brain, according to Jessica Oliphant, deputy director at the FDA’s National Center for Toxicological Research. However, research does not show whether binding leads to harmful side effects from drugs.
Earlier research also found that the drug penetrated the brains of rats.
However, more information is needed to confirm how the drug accumulates in the nervous system, according to the deputy director.
Even after receiving it, the FDA will not update the drug’s label based on the information presented.
USA TODAY has reached out to the FDA for comment.
Brain receptors that control emotions
Brain receptors that the drug binds to include, but are not limited to, the following, according to Reuters:
- A sense of control
- Impulse control
- Knowledge
- Sleep
Research does not show whether binding leads to harmful side effects from the drug, or who is at risk.
However, the medicine “definitely does something related to it,” Julia Marschallinger, a scientist at the Austrian Center for 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 marketed by Merck & Co., is a prescription drug that was launched in 1998 and is used to prevent and treat asthma and allergy symptoms, according to the Cleveland Clinic, by “reducing inflammation in the airways, to make breathing easier.”
Singulair comes in generic versions with the following names:
- Montelukast
- Montelukast No
- Montelukast sodium
Brand-name and generic versions are prescribed for adults and children.
Early advertisements for the drug said it had negative side effects and was compared to a sugar pill, according to Reuters. But, more than two decades later, the drug has been linked to mental health problems and events 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
- It’s scary
- Confusion
- Amazing views
- Irritation
- Hostile
- Thoughts of killing or harming yourself
- Worsening mood
- Depression
Users may also experience trouble sleeping and vivid dreams or nightmares.
Anyone taking the medication and experiencing the side effects listed above should report it to their health care team immediately, according to the medical center.
Medications are associated with many suicides
In 2019, more than 20 years after Singulair hit the market, thousands reported experiencing neuropsychiatric events after being prescribed the drug. Many 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 suicide.”
FDA takes regulatory action
In October, the FDA listed drugs with serious risks or new safety information and that drug-related mental illnesses will require the agency to review the “need for regulatory action.”
This is not the first time this drug has come under FDA scrutiny.
In 2020, the FDA announced that the drug would require a Boxed Warning, its “prominent warning,” about “adverse mental health effects” and advised against its use to treat hay fever .
It already included information about the risk of suicidal thoughts or actions, but some health care professionals and patients were unaware of the risk.
“We have determined that a stronger warning is warranted after conducting an extensive review of available information and convening a panel of outside experts,” the FDA said in a release.
Contributing: Reuters.
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