Asthma drug warning after 500 neuropsychiatric reactions reported in young children

More than 500 side effects involving an asthma drug have been reported in children under nine years of age, for which new warnings about its risks will be issued.

The Medicines and Healthcare products Regulatory Agency (MHRA) announced last week that more prominent warnings would be added to the information on boxes of the asthma drug montelukast, sold under the brand name Singulair.

Officials announced the measure after families raised concerns about reported side effects, including sleep disorders, 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 package leaflet in all montelukast medicine packs in Britain to include prominent warnings and advice about the risk of serious behavioral and mood-related changes.”

The Yellow Card program for reporting suspected side effects of medicines has registered 1,282 reports of suspected neuropsychiatric side effects of montelukast. The figures show that between 1998 and March 31, 2024, there were 541 reports of psychiatric side effects for children aged 0 to 9 years. This compared to 141 for young people aged 10 to 19 and 155 for adults aged 20 to 39.

Graham Miller, from south-west London, whose son Harry committed suicide aged 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 to see their son’s inquest reopened. Graham said of the warnings: “We think it gives some meaning to Harry’s death because it warns other children of the dangers.”

An action group is supporting families who believe their children have experienced adverse side effects. Michelle Johnstone, 44, from Northampton, said her son Fergus, now 10, had become irritated after being given the drug when he was about 18 months old. “There were terrible behavioral problems,” she said. “He hit his head against the wall. He was the most calm baby and it just came out of nowhere.”

The drug was discontinued after nine months of treatment but restarted in October 2019. Michelle and her husband, Richard, were reluctant to restart treatment because of the behavioral problems, but were assured by medical staff that their son was unlikely to be affected. the suspected side effects again.

The drug was discontinued again in June 2022 after her son again experienced similar suspected side effects from the drug. Michelle said: “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 don’t have the ability to tell you when something is changing in them.”

The UK campaign group for montelukast said in a statement: “As early as 2017, when Nice (the National Institute for Health and Care Excellence) held a consultation on montelukast, highlighting the potential cost savings to the NHS, patients raised concerns about the severity of it. of the adverse side effects (and) the potential impact on the developing brain.”

The MHRA says the drug’s benefits still outweigh its risks for most patients. Officials say montelukast remains an acceptably safe and effective drug for asthma.

Organon, 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 side effects are taken seriously and, as with all our medicines, we continuously monitor the safety of Singulair.”