London (Parliament News) – The MHRA announces stronger warnings for montelukast, an asthma drug, due to over 500 neuropsychiatric reactions in children under nine. Families advocate for awareness after concerns about side effects arise.
More than 500 negative neuropsychiatric reactions have been noted in children under the age of nine concerning an asthma drug which is to get further warnings over its risks.
What Concerns Prompted MHRA’s Regulatory Action?
The Medicines and Healthcare Products Regulatory Agency (MHRA) reported last week that more prominent cautions would be added to the information delivered on boxes of the asthma drug montelukast, marketed under the brand name Singulair.
According to the Guardian, Officials announced the move after worries were raised by families over conveyed side effects, which can include sleep disturbances, aggression and depression. Many parents express they were not properly warned of the risks.
Dr Alison Cave at the MHRA stated: “Patient safety is our top priority. We have now taken regulatory action to update the leaflet included in all montelukast medicine packs in the UK with prominent warnings and advice about the risk of serious behaviour and mood-related change.”
How Many Neuropsychiatric Reactions Were Reported?”
The Yellow Card plan for the reporting of suspected negative side effects in drugs has recorded 1,282 reports of supposed neuropsychiatric adverse drug reactions to montelukast. The figures indicate there were 541 adverse psychiatric reaction reports for children aged 0-9 between 1998 and 31 March 2024. This compares with 141 for young people aged 10-19 and 155 for adults aged 20-39.
What Triggers Parents’ Alarm Over Asthma Medication?
Graham Miller, from south-west London, whose son Harry took his life aged 14 in February 2018, welcomed the new cautions. Harry’s mother, Alison Miller, expressed she was convinced the drug had directed her son’s death and the couple would like to witness their son’s inquest reopened. Graham spoke of the warnings: “We feel it brings some meaning to Harry’s death because it alerts other kids to the dangers.”
An action group sponsors families who believe their children have mourned adverse side effects. Michelle Johnstone, 44, from Northampton, expressed that her son, Fergus, now 10, had become restless after he was given the medication at about 18 months old. “There were awful behavioural issues,” she stated. “He would hit his head against the wall. He had been the most peaceful baby and it just came out of nowhere.”
The drug was discontinued after nine months of treatment but continued again in October 2019. Michelle and her husband, Richard, were reluctant to begin the treatment again because of the behavioural problems but were assured by the medical team it was unlikely their son would suffer the suspected side effects again.
The drug was halted again in June 2022 after her son again experienced comparable suspected adverse reactions to the drug. Michelle stated: “When he took it, his asthma was so bad I think we would have done anything. “I’m not sure it should be prescribed to children, especially young children, because they can’t tell you when something is changing in them.”
Who Advocates for Better Awareness of Drug Risks?
The Montelukast UK action group expressed in a statement: “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.”