A popular asthma pill linked to depression in children will now be sold with “Black Box Warning,” the most serious of FDA warnings about prescription drugs.
The warning will address serious mental health side effects and will recommend that allergy medicine montelukast (brand name: Singulair) be prescribed only when there’s no other medical option.
Physicians or patients have reported serious side effects to the Food and Drug Administration on at least six drugs or drug classes linked to suicidal thoughts or actions.
Those side effects include depression, aggression, nightmares and headaches. A Netherlands study linked the drug to depression and nightmares in children.
In fact, FDA identified 82 cases of completed suicide linked to montelukast.
“The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks,” said Sally Seymour, MD, the director of the Division of Pulmonary, Allergy, and Rheumatology Products at the FDA’s Center for Drug Evaluation and Research.
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