An asthma drug prescribed to millions of children has been found to cause suicidal thoughts, hallucinations and other psychiatric conditions.
Government-backed research found that montelukast, sold under the brand name Singulair, attaches to cells in the brain that control mood, decision making, attention, impulse control and sleep.
This research was prompted by thousands of tragic stories reported by families whose children were taking montelukast over the years - including Harrison Sellick who attempted suicide at just five years old.
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There have been 82 suicides linked to the drug that have been reported to the FDA's adverse event tracker since 1998 and the drug has been linked to depression, anxiety, agitation, nightmares and 'full psychosis'.
The FDA added a black box label to the drug - the strictest warning that indicates the medication can lead to death or serious injury - in March 2020, and urged doctors to communicate these risks to patients.
Officials at the time also initiated an investigation into the drug by independent researchers.
The findings from this investigation were just presented by representatives from the FDA's National Center for Toxicological Research at the American College of Toxicology's annual meeting this week.
They confirmed that these earlier complaints show that for some patients, there is a link between the drug and psychiatric conditions.