Popular asthma drug Singulair may be linked to mental health side effects and suicide: FDA

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New study on a commonly prescribed drug asthma New research shows that it binds to receptors in the brain and is linked to serious mental problems and suicide.

The Food and Drug Administration presented preliminary results from a study of asthma drug Singulair to a “limited audience” at a meeting of the American College of Toxicology in Austin, Texas, according to Reuters. , Which review scientific presentation.

According to Jessica Oliphant, deputy director of the FDA’s National Center for Toxicology Research, laboratory tests showed “significant binding” of the drug to multiple receptors in the brain. However, studies have not shown whether the binding leads to harmful side effects of the drug.

Previous studies also showed that the drugs penetrated the brains of rats.

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

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

USA TODAY has reached out to the FDA for comment.

Brain receptors responsible for mood

According to Reuters, the brain receptors to which the drug binds are involved in the following activities, among others:

• Ruling the mood

• Pulse control

• Cognition

• To sleep

The studies do not show whether the binding leads to harmful side effects of the drug or who is at risk.

But the drug “definitely does something disturbing,” 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 by Marschallinger and Ludwig Aigner, another scientist at the same institute.

What is Singulair?

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

Singulair is available in generic versions with the following names:

• Montelukast

• Montelukast Na

• Montelukast sodium

Brand-name and generic versions are prescribed for adults and children.

According to Reuters, early advertisements for the drug stated that it had mild side effects and were compared to a sugar pill. However, more than two decades later, the drug has been linked to mental health problems and episodes in patients to whom it is prescribed.

What are the side effects of Singulair?

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

Users may also experience trouble sleeping and vivid dreams or nightmares.

The medical center recommends that anyone taking the drug and experiencing the side effects listed above should report it to their doctor immediately.

Drugs linked to dozens of suicides

In 2019, more than 20 years after Singulair hit the market, thousands of people reported having neuropsychiatric episodes after being prescribed the drug. A dozen or so patients also committed suicide.

“A variety of mental health adverse effects have been reported,” according to a statement published in 2022, “including completed suicides.”

FDA takes regulatory action

In October, the FDA concluded that the drug poses a serious risk or contains new safety information, and also said that mental disorders associated with the drug would require the agency to evaluate the “need for regulatory action.”

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

In 2020, the FDA announced that the drug would require: Boxed warningwhich provides a “most important warning” about the drug’s “serious mental health side effects” and recommended limiting its use to treat hay fever.

It already included information on the risk of suicidal thoughts or actions, but some healthcare workers and patients were unaware of these risks.

“After conducting an extensive review of available information and convening a panel of outside experts, we have determined that a stronger warning is needed,” the FDA said in a statement.

Contributor: Reuters.

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