Asthma drug montelukast, also known as Singulair, has been found to cause psychiatric side effects in children, including suicidal thoughts, hallucinations, and other mental health conditions. Research conducted by the US government found that montelukast binds to brain cells that control mood, decision-making, and attention, leading to serious side effects in some patients. The drug has been linked to numerous cases of suicide in both the US and UK, garnering the attention of regulators and healthcare agencies.
The montelukast UK action group estimates that the drug was prescribed to at least 35,000 children in the UK in 2022, with around 12 million people in the US taking the medication. Despite being widely used to treat asthma symptoms in children as young as six months old, montelukast has been associated with a range of mental health issues, including depression, anxiety, nightmares, agitation, and psychosis. The FDA has reported 82 suicides linked to montelukast since 1998, raising concern about the safety of the drug.
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has received over 1,200 reports of psychiatric side effects related to montelukast since 1998, with nearly half of these involving children under nine. The complaints were submitted through the Yellow Card scheme, which allows patients and healthcare professionals to report adverse reactions to medications. While the US and Europe have issued black box warnings on montelukast boxes, highlighting the potential for serious side effects, the UK and Australia have not yet mandated such warnings.
In response to the growing concerns about montelukast’s psychiatric side effects, the MHRA announced in March that the drug is under review. The agency issued a safety announcement in September 2019, highlighting the potential for neuropsychiatric reactions, including hallucinations and obsessive-compulsive symptoms. Patients have reported disturbing hallucinations, such as seeing red-eyed demons and melting walls, while the NHS lists mood changes, depression, aggression, and thoughts of self-harm as serious side effects of the drug.
Recent research presented by the FDA’s National Center for Toxicological Research at the American College of Toxicology’s annual meeting confirmed earlier complaints linking montelukast to psychiatric issues. Preliminary results showed significant binding of the drug to brain receptors, potentially explaining its neuropsychiatric effects. While more research is needed to fully understand how montelukast affects brain cells and leads to mental health issues, the FDA stressed that their investigation is ongoing, and final conclusions have not yet been reached.
The FDA’s research findings add to mounting concerns about montelukast’s safety, particularly in children. While the drug is still approved for use to treat asthma symptoms, regulators and healthcare professionals are urging caution and increased awareness of its potential side effects. The FDA’s ongoing studies are part of efforts to better understand the mechanisms by which montelukast can trigger psychiatric symptoms, paving the way for improved safety measures and warnings for patients and healthcare providers.
