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More than 500 adverse neuropsychiatric reactions have been reported in children under the age of nine involving an asthma drug that is due to receive new warnings about the risks.
The Medicines and Healthcare products Regulatory Agency (MHRA) announced last week that more prominent warnings will be added to the information provided on the boxes of the asthma drug montelukast, sold under the brand name Singulair.
Officials announced the move after families raised concerns about reported side effects, which can include sleep disturbances, aggression and depression. Many parents say they were not properly warned about the risks.
Dr Alison Cave from the MHRA said: “Patient safety is our top priority. We have now taken regulatory action to update the leaflet included in all packs of montelukast in the UK with prominent warnings and advice about the risk of serious behavior and mood changes.’
The Yellow Card Scheme for reporting suspected adverse drug reactions has recorded 1282 reports of suspected neuropsychiatric adverse drug reactions to montelukast. The figures show there were 541 reports of adverse psychiatric reactions in 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 years old.
Graham Miller of south-west London, whose son Harry committed suicide at the age of 14 in February 2018 welcomed the new warnings. Harry’s mother, Alison Miller, said she was convinced the drug led to her son’s death and the couple would like their son’s inquest to be reopened. Graham said of the warnings: “We think it gives some meaning to Harry’s death because it warns other children of the dangers.”
Action Group supports families who believe their children have suffered adverse side effects. Michelle Johnstone, 44, from Northampton, said her son Fergus, now 10, became agitated after being given the drug at around 18 months of age. “He had terrible behavioral problems,” she said. “He would bang his head against the wall. He was the calmest baby and he just came out of nowhere.
The drug was stopped after nine months of treatment, but restarted in October 2019. Michelle and her husband, Richard, did not want to start treatment again because of the behavioral problems, but were reassured by medical staff that it was unlikely their son would suffer the suspected side effects again .
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The drug was stopped again in June 2022 after her son again experienced similar suspected adverse reactions to the drug. Michelle said: “When he got him 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 don’t have the capacity to tell you when something is changing in them.”
montelukast uk The Action Group said in a statement: “Back in 2017 when Nice [the National Institute for Health and Care Excellence] consulted on montelukast, highlighting potential cost savings for the NHS, patients express their concerns about the severity of adverse side effects [and] the potential to affect the developing brain.”
The MHRA says the benefits of the medicine continue to outweigh the risks for most patients. Authorities say montelukast remains an acceptably safe and effective asthma drug.
Organon, which is responsible for Singulair in the UK, said: “Nothing is more important to Organon than the safety of our medicines and the people who use them. Reports of adverse events are taken seriously and, as with all of our medicines, we are constantly monitoring the safety of Singulair.”
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