Activists are demanding stricter controls and more prominent warnings on the commonly prescribed asthma and allergy drug montelukast, which has seen children as young as three suffering traumatic side effects, including suicidal thoughts.
Families of patients affected by the medication, which is now under review by the UK drugs regulator, say they were not properly warned about potential risks.
Montelukas has been associated with night terrors, depression and in rare cases, hallucinations or suicidal behaviour, reports The Guardian, with the Medicines and Healthcare products Regulatory Agency (MHRA) confirming this weekend that it was reviewing the risks after identifying “further concerns”.
Tanya Hinder, from the montelukast UK action group, said: “Those affected have reported uncontrollable aggression, children attacking family, and suffering very intrusive thoughts. Tragically, there have also been attempted and reported suicides.”
The UK action group for the drug, which represents nearly 3 500 members, is campaigning for more prominent warnings, stricter controls and support for those affected.
The asthma and allergies drug was launched by Merck in 1998. It stops airways from narrowing and helps to prevent asthma attacks. Side effects, including behaviour and mood changes, are listed in the patient information sheet, but campaigners say the warnings should be printed on the packet and flagged by health professionals.
There were 4.3m montelukast prescriptions in 2022/23 in England, at a cost of £6.69m. The action group estimates that about 350 000 patients are prescribed the drug in England, including more than 35 000 children, based on an analysis of NHS data. It can be given to babies as young as six-months-old.
In the US, the drug has had a black box warning since 2020, the highest safety warning drugs can be assigned by the FDA. The agency has highlighted animal studies which suggest the drug can cross the blood-brain barrier, a membrane that acts as a filter and keeps out harmful substances and pathogens.
On 21 February, Letitia James, the New York Attorney-General, wrote to the FDA, urging it to take “immediate action” over the drug, which is sold under the brand name Singulair. She said “tragic adverse mental events” involving children continue to be reported.
The MHRA said clearer warnings were included in the product information about the risk of neuropsychiatric effects after a European review in 2019, which also highlighted the risks of neuropsychiatric reaction, with some side effects more frequently reported in children.
The agency said it was conducting a further review to consider any new data on the risk, indicators of lack of awareness with patients, carers and healthcare professionals, and whether any further regulatory action is needed.
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