‘A healthy child dies and there is no change’: Parents’ anger over lack of warnings for the hit asthma drug

Harry Miller was a popular teenager, appreciated for his sharp humor, his ability to get along with everyone and his eagerness “for the next adventure.”

In the fall of 2017, he struggled with difficult thoughts and feelings of anger. Harry, who was fourteen and lived in south-west London, confided his inner turmoil to friends and family.

“I just have fits of rage,” he told his mother one day. “It’s like I’m suddenly going crazy and I have no control over it anymore. I don’t know what’s going on.”

Two years earlier, Harry had been prescribed the drug montelukast for his asthma. Unbeknownst to his parents, a range of psychiatric reactions had been reported in association with montelukast treatment, including aggression, depression and suicidal ideation.

Harry’s parents, Graham Miller, the director of Christian charity London City Mission, and Alison, were not properly warned about the possible side effects.

Their son was referred to NHS child and adolescent psychiatry in January 2018, but he missed an appointment because it was sent to the wrong person.

On February 11, 2018, Harry was found dead at the family home, and an inquest later recorded a verdict of suicide. He was described as a “superstar who burns bright” in a tribute by friends at St Cecilia’s Church of England school in Southfields, south-west London.

Two years after his death, his father read an online warning about the side effects of montelukast from the Medicines and Healthcare Products Regulatory Agency (MHRA). It said these may very rarely include suicidal behavior. Graham Miller said: “It is an absolute shame that parents are being given psychoactive substances to give to their children without proper warning of the risk.”

This weekend the MHRA confirmed the drug is under review. A British campaign group for montelukast is calling for more prominent warnings about the drug’s potential side effects.

Montelukast was first approved for use in Britain in 1998 and is prescribed for the treatment of asthma and allergies. Drug company Merck has generated more than $50 billion in revenue worldwide, according to a Reuters analysis of company documents.

The patent for Singulair, the brand name of montelukast, expired in 2012, leaving cheap generic versions available. It was an effective drug and offered the NHS an opportunity to save millions of pounds.

The National Institute for Health and Care Excellence (Nice) issued draft guidance in December 2016 that a leukotriene receptor antagonist, the class of drugs to which montelukast belongs, should be given before a more expensive combination inhaler. It was estimated that for every 10,000 patients taking the drug according to the new recommendation, the NHS could save £3 million a year.

The British activist group Montelukast unsuccessfully opposed this measure, warning that the drug should be used as a “last resort” due to the risk of neuropsychiatric side effects.

Jenny Llewellyn, 33, a nursery assistant who lives near Swindon in Wiltshire, said her daughter Lottie was prescribed the drug in September last year, when she was just three. It seemed to bring about abrupt changes in her behavior.

“She started having scary nightmares,” Llewellyn said. “Really bad things. Then her behavior started to change. She hit us. She shouted at us.”

Llewellyn said she was “shocked” that her daughter had been given the drug without being told to watch for signs of adverse side effects. She said her daughter was now back to her ‘old self’ after the medication was stopped.

Hannah, 45, who lives in Manchester and asked that her surname not be used, said her daughter was prescribed the drug in 2015 at the age of six but never linked anger outbursts and hallucinations to the medication.

“She started having outbursts that came out of nowhere,” Hannah said. “I went to doctors and psychologists about the problems we were dealing with, but no one did a medication review and looked at this drug.” She said her daughter had severe withdrawal symptoms since stopping montelukast.

Tanya Hinder, from the British campaign group, said: “We have had reports of those affected running in front of vehicles, jumping out of cars and climbing out of windows in extreme distress. There are reports of knives being used for self-harm and to threaten others.”

The U.S. Food and Drug Administration (FDA) found a variety of adverse psychiatric events linked to the drug in a review of 2008-2009 data, including aggression, depression and suicidal behavior. It said some reports appeared consistent with a drug-induced effect. The package insert for montelukast states that suicidal thoughts and actions can be side effects, but are very rare.

An overview of 59 studies in a report published in the European Respiratory Review last year found no increase in the risk of suicide among asthmatics taking the drug. Families say more research is needed.

The Millers were so concerned about the risks of the drug after Harry’s death that they met with Nadine Dorries, then Health Secretary, and the MHRA in February 2021. They were assured that changes would be made to ensure patients were properly informed about the potential adverse side effects.

The Millers said this weekend that the changes they wanted to see, including a warning on the drug package about the risk and better monitoring of patients taking the drug, still haven’t been implemented.

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. “A perfectly healthy, happy child dies after taking this medicine and there is no change,” Alison said. “It’s unacceptable.”