Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) says more prominent warnings would be added to the information provided on boxes of the asthma drug montelukast, sold under the brand name Singulair, after more than 500 adverse neuropsychiatric reactions were reported in children under nine.
Reported side effects can include sleep disorders, aggression and depression, it added, after hundreds of parents say they were not properly warned of the risks.
Dr Alison Cave at the MHRA told The Guardian: “We have now taken regulatory action to update the leaflet in all montelukast medicine packs in the UK with prominent warnings and advice about the risk of serious behaviour and mood-related change.”
The Yellow Card scheme for the reporting of suspected adverse side effects in drugs has recorded 1 282 reports of suspected neuropsychiatric adverse drug reactions to montelukast.
There were 541 adverse psychiatric reaction reports for children up to the age of nine between 1998 and 31 March 2024. This compares with 141 for young people aged 10-19 and 155 for adults aged 20-39.
An action group, which supports families who believe their children have suffered adverse side effects, said: “As far back as 2017, when Nice (the National Institute for Health and Care Excellence) consulted on montelukast, highlighting the potential cost saving for the NHS, patients were expressing their concerns regarding the severity of the adverse side effects (and) the potential for impact on the developing brain.”
The MHRA says the benefits of the drug continue to outweigh the risks for most patients, and that montelukast remains an acceptably safe and effective drug for asthma.
Organon, which is responsible for Singulair in the UK, said: “Reports of adverse events are taken seriously and, as with all of our medicines, we continually monitor the safety of Singulair.”
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