New York AG Calls for More Stringent Warnings for Singulair Pediatric Suicide Risks

The popular asthma drug Singulair poses a serious mental health threat to children, increasing their risk of suicide, aggression, and other mental health problems, New York Attorney General Letitia James warns.

On February 21, the attorney general sent a letter (PDF) to the U.S. Food and Drug Administration (FDA) calling for changes to be made to Singular’s warning label. The letter indicates that Singulair’s mental health side effects make it a safety risk to children in the U.S.

Singulair (montelukast) is an asthma medication that belongs to a class of drugs known as selective leukotriene receptor antagonists. It is widely used among both children and adults, involving a pill taken orally once a day to treat asthma, exercise induced asthma and seasonal allergies.

Although most consumers believe the medication is safe and carries few serious side effects, the FDA issued a drug safety communication about the Singulair suicide risks in March 2020, announcing that the strongest label warning possible would be added regarding mental health side effects linked to the drug, including a prominent “black box” containing information about the risk of suicidal thoughts and behavior.

However, James says more action should be taken to help protect children amid an ongoing mental health crisis affecting the nation’s youth.

Singulair Mental Health Concerns

Concerns over the pediatric suicide risks and other mental health side effects of Singulair date back for at least 10 years. In 2014, an FDA drug advisory committee rejected a proposal to allow Singulair to be sold over-the-counter, based on data from clinical trials highlighting its side effects. That was followed by the 2020 FDA black box warning requirement.

The FDA identified 82 cases of “completed suicide” linked to Singulair use at that time. The agency indicated that 45 of those cases involved patients older than 17 years old, 19 cases involved minors 17 years old or younger, and 18 cases where no age was indicated.

In 2022, according to FDA-conducted research, children using Singulair for asthma faced a greater risk of suffering from anxiety and insomnia and were more likely to be prescribed antidepressants. Other research has concluded that 62% of pediatric patients using Singulair suffer neuropsychiatric events.

Despite the warnings and research, many instances of suicide, aggression, and depression are still reported among pediatric patients using Singulair, the attorney general’s letter notes.

“Since that decision in March 2020, the prevalence of tragic adverse mental health events, including aggression, depression, and suicide, continue to be widely reported, and disproportionately so for pediatric patients,” the letter states. “Of the estimated 12 million people prescribed the medication, an estimated 1.5 million are children. The effects of montelukast on children are of particularly urgent concern in light of the national youth mental health crisis plaguing out State and the subsequent strain on our health care system.”

Stronger Singulair Side Effects Warnings Needed

The letter argues the current black box warning is insufficient, indicating that many parents are still unaware of Singulair pediatric suicide risks. James calls for an updated warning to include language highlighting the specific risks of Singulair mental health side effects, and indicate the benefits of using the asthma medication may not outweigh the risks.

The letter also calls for the FDA to conduct new investigations into the medication, as well as send warning letters to doctors, pharmacists, and other healthcare providers warning them about the risks, and to implement other interventions to help prevent more children from suffering Singulair psychiatric side effects.

Organon officials have said the company is taking reports of the adverse events seriously. However, a number of Singulair lawsuits have been filed since the black box warning was added, mainly in New Jersey state court, indicating the manufacturer failed to adequately warn patients and health care professionals about the drug’s suicide risks, resulting in serious injuries and deaths.

Singulair brought in more than $411 million in sales for Organon in 2022.