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New research on widely prescribed drugs asthma New research has found that it binds to receptors in the brain and is linked to severe mental health problems and suicide.
According to Reuters, the Food and Drug Administration gave a “limited review” of preliminary results from a study on the asthma drug Singulair, commonly sold as montelukast, at a meeting of the American Society of Toxicology in Austin, Texas, on November 20. The presentation was made to an audience of 200,000 people. , Which reviewed scientific presentation.
Jessica Oliphant, deputy director of the FDA’s National Center for Toxicology Research, said clinical tests showed the drug “significantly binds” to multiple brain receptors. However, studies have not shown whether that binding causes the drug’s harmful side effects.
Previous studies also found that the drug penetrated the brains of rats.
But the deputy director says more data is needed to see how the drug collects in the nervous system.
Despite this finding, the FDA has no intention of updating drug labels based on the data presented.
USA TODAY has reached out to the FDA for comment.
Brain receptors that control mood
According to Reuters, the brain receptors that the drug binds to include, but are not limited to:
- governing mood
- impulse control
- cognition
- sleep
The study does not show whether the binding causes harmful side effects from the drug or who is at risk.
But Julia Marshalinger, a scientist at Austria’s Institute for Molecular Regenerative Medicine, told Reuters the drug is “definitely doing something worrying.”
When the FDA added a black box to the drug in 2020, it cited research by Ludwig Aigner, another scientist at the same institute as Marshallinger.
What is Singulair?
Singulair, originally sold by Merck & Co., is a prescription drug released in 1998 that is used to prevent and treat symptoms of asthma and allergies. cleveland clinicby “reducing airway inflammation and making breathing easier.”
Singulair has generic versions named:
- montelukast
- Montelukast Na
- montelukast sodium
Name brand and generic versions are prescribed to adults and children.
According to Reuters, early advertisements for the drug said it had benign side effects and was comparable to a sugar pill. However, more than 20 years later, the drug has been linked to mental health issues and episodes in patients prescribed it.
What are the side effects of Singulair?
According to , below are some of the side effects of the drug. cleveland clinic:
- anxiety
- nervous
- confusion
- hallucination
- irritation
- hostility
- Thoughts about suicide or self-harm
- worsening of mood
- depression
Users may also experience sleep disturbances, vivid dreams, and nightmares.
The medical center says anyone who is taking the drug and experiences any of the side effects listed above should report it to their medical team immediately.
Drug therapy linked to dozens of suicides
In 2019, more than 20 years after Singulair hit the market, thousands of people reported experiencing neuropsychiatric symptoms after being prescribed the drug. Dozens of patients also committed suicide.
“A variety of mental health side effects have been reported, including suicide attempts,” according to a statement released in 2022.
FDA takes regulatory action
In October, the FDA listed the drug as having significant risks and new safety information, and said the FDA would need to evaluate the “need for regulatory action” regarding psychiatric disorders associated with the drug. said.
This is not the first time the drug has come under FDA scrutiny.
In 2020, the FDA announced that this drug would require: framed warningcited the drug’s “serious mental health side effects” as its “most notable warning” and recommended limiting its use for the treatment of hay fever.
This already included information about the risks of suicidal thoughts and behavior, but some health professionals and patients were unaware of the risks.
“After an extensive review of available information and a panel of outside experts, we determined that a stronger warning is needed,” the FDA said in a release.
Contributed by: Reuters.
Julia is a trend reporter for USA TODAY. you can connect with her linkedinfollow her ×, Formerly known as Twitter, Instagram and TikTokEmail: @juliamariegz or [email protected]
