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Back in March 2020, the U.S. Food and Drug Administration (FDA) announced that it was strengthening the existing warnings about serious behavior and mood-related side effects associated with asthma medication Singulair (montelukast) and its generics.

The drug already had warnings about mental health side effects, including suicidal thoughts or actions, but an FDA analysis showed that many doctors and patients remained unaware of the risks. To increase awareness, the agency decided a stronger warning was needed and ordered the manufacturers to add a boxed warning—the most serious kind—to alert users to the risk of mental health side effects.

Meanwhile, a growing number of patients who used the drug—or their families—have filed personal injury lawsuits, claiming that Singulair or its generic versions caused suicide, depression, and other similar side effects. The New Jersey Supreme Court recently received an application for all Singular cases in that state to be consolidated into one court for more efficient pre-trial proceedings.

FDA Reviews Evidence and Finds Mental Health Side Effects

Singulair (montelukast) is a prescription medicine first approved by the FDA in 1998 to prevent asthma attacks and for the long-term treatment of asthma in adults and children one year and older. It is also approved to prevent exercise-induced asthma in patients 6 years and older, to help control the nasal symptoms of seasonal outdoor allergies in patients 2 years and older, and to treat year-round indoor allergies in those 6 months and older.

As far back as March 2008, the FDA warned about the potential mental health side effects associated with montelukast. In its first warning that year, the administration stated it was investigating a “possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide.”

In August 2009, the FDA announced an update to the “Precautions” section of the prescribing information on the drug, to include information about these potential side effects.

Investigators continued to review the reports coming including patient and doctor reports and observational and animal studies. They found that a wide variety of mental health side effects have been linked with Singulair, including completed suicides. More specifically, between 1998 and 2019, they identified 82 cases of completed suicide associated with montelukast.

When taking a comprehensive view of the mental health side effects, the data showed that some occurred during treatment with the drug and resolved after patients stopped using it, while others continued or developed after patients stopped using the medication.

The FDA did acknowledge that data regarding the mental health risks associated with montelukast are limited. Nevertheless, based on the available evidence, it decided to require a boxed warning.

New Jersey Supreme Court Considers Singulair Multicounty Litigation

On September 7, 2021, Acting Administrative Director of New Jersey Courts, Glenn A. Grant, issued a Notice to the Bar indicating that plaintiffs had filed an application for all Singulair lawsuits to be consolidated into one court for pre-trial proceedings. Those wishing to comment on the application have until October 10, 2021, to do so.

Should the Supreme Court agree to consolidate these cases, it would create multicounty litigation (MCL), which is a type of litigation involving large numbers of claims all associated with a single product and filed in the same state.

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