Singulair Asthma Drug Label To Be Updated With More Prominent Warnings About Sleep Disorders, Aggression and Depression in U.K.

The label update comes several months after the New York Attorney General called for more stringent Singulair pediatric suicide warnings for the widely used asthma drug, as incidents of self-harm continue to be reported.

U.K. health regulators are calling for the asthma drug Singulair to update its label to include warnings of serious mental health risks for young children and adults.

The Medicines and Healthcare products Regulatory Agency (MHRA) announced the Singulair label update on April 29, adding more prominent warnings about the risk of sleep disorders, aggression and depression to the prescription guide, including a black box warning.

Singulair (montelukast) is a medicine for asthma that belongs to a group of drugs called selective leukotriene receptor antagonists. It is used by both children and adults who take one pill by mouth each day to treat asthma, exercise-induced asthma, and seasonal allergies.

Singulair Label Update

For all age groups, common suspected neuropsychiatric reactions to montelukast included sleep disorders, hallucinations, anxiety, depression, and changes in behavior and mood. Among younger children (up to 12 years old), frequent reactions included aggression, nightmares, and anxiety. Older children (13 to 17 years old) commonly reported suffering anxiety, suicidal thoughts, and depression.

Concerns regarding the potential for pediatric suicide and other mental health side effects associated with Singulair have been present for over a decade. The U.S. Food and Drug Administration (FDA) added a similar Singulair black box warning in 2020, after it identified 82 cases of completed suicide linked to Singulair usage. Of these cases, 45 involved patients aged 17 or older, 19 involved minors aged 17 or younger, and 18 lacked age information.

Earlier this year, New York Attorney General Letitia James called for even more stringent Singulair pediatric suicide warnings, indicating that many parents were still not aware of Singulair mental health risks.

The MHRA recommends doctors prescribing montelukast be alert for neuropsychiatric reactions in all patients, including children and teens. These reactions may include sleep problems, hallucinations, anxiety, depression, and changes in behavior or mood. Patients and caregivers should be aware of these risks and seek medical help quickly if they notice any of these reactions.

If new or worsening symptoms arise, they recommend doctors discontinue Singulair treatment. Patients and caregivers should carefully review the Patient Information Leaflet for neuropsychiatric reactions.