Montelukast: Regulator reviewing asthma drug over concerns about mental health effects

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) is investigating the risks associated with montelukast, which is used to treat asthma and allergic rhinitis, after concerns over neuropsychiatric reactions to the drug. It said its review will cover new data on risks, lack of awareness of side effects among patients, carers, and clinicians, and whether further regulatory action is needed.The review comes after families of children who take the drug reported serious side effects, including aggression, intrusive thoughts, and suicidal behaviour. They are calling for clearer warnings about side effects.1The MHRA had previously said that side effects associated with montelukast include sleep disturbances, depression, and agitation (which may affect up to one in 100 people), disturbances of attention or memory (up to one in 1000), and hallucinations and suicidal behaviour (up to one in 10 000). In 2019 it issued a reminder to clinicians to be alert to neuropsychiatric…
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