Asthma drug safety concerns raised after toddler suffers serious side effects

Children as young as three are suffering traumatic side effects from a best-selling asthma drug that is now under review by the UK’s medicines regulator.

Family members say asthma patients, including many children, were not properly warned about the risks of the commonly prescribed drug montelukast.

It has been associated with night terrors, depression, and rarely hallucinations or suicidal behavior.

The Medicines and Healthcare products Regulatory Agency (MHRA) confirmed this weekend that it was reviewing the risks of the drug after identifying “further concerns”.

Tanya Hinder, of the UK Montelukast Action Group, said: “Affected people report uncontrollable aggressive behaviour, with children attacking family members and suffering very intrusive thoughts. Sadly, there are also Suicide Attempts and Reports.”

Britain’s action group on the drug, which has nearly 3,500 members, is campaigning for more prominent warnings, tighter controls and support for those affected. It said patients should first consult their doctor if they have any concerns.

Graham and Alison Miller were among the families calling for action after their son Harry, an asthma sufferer, was taking medication in February 2018 During this period, he committed suicide at the age of 14. They learned about possible side effects of montelukast two years after their son’s death and wanted to reopen the investigation into him.

Nursery assistant Jenny Llewellyn, 33, said her daughter Lottie was prescribed the drug when she was three. This seemed to trigger a sudden change in her behavior. “It’s all doom and gloom,” Llewellyn said. “She would go to bed crying and wake up crying.”

This breakthrough asthma and allergy drug was launched in 1998 by pharmaceutical giant Merck. It stops airways from narrowing and helps prevent asthma attacks. The drug’s side effects, including behavioral and mood changes, are listed on patient information sheets, but campaigners say warnings should be printed on packaging and marked by health professionals.

In 2022/23, there were 4.3 million prescriptions for montelukast in the UK, costing £6.69 million. Based on analysis of NHS data, the action group estimates that around 350,000 patients in England are taking the drug, including more than 35,000 children.Can be given to babies as young as six months old.

In the United States, the drug has been subject to a black box warning since 2020, and the FDA can designate drugs with a maximum safety warning. The agency highlighted animal studies that showed the drug could cross the blood-brain barrier, a membrane that acts as a filter and blocks the entry of harmful substances and pathogens.

On February 21, New York Attorney General Letitia James Write a letter to the FDA, urged the company to take “immediate action” on the drug, which is sold under the brand name Singulair. She said “tragic adverse psychological incidents” involving children continued to be reported.

The MHRA said that following a European review in 2019, product information contained clearer warnings about the risk of neuropsychiatric effects. Risk of neuropsychiatric reactionssome side effects are more common in children.

The agency said: “We are conducting further review to consider any new data on risk, indicators of lack of awareness among patients, caregivers and healthcare professionals, and whether any further regulatory action is warranted.

“We are now in the final stages of our review. We continue to closely monitor reports of suspected neuropsychiatric adverse reactions to montelukast and initiated the current review if further concerns were identified.”

Organon, the Merck subsidiary responsible for montelukast in the UK, said: “Nothing is more important to Organon than the safety of our medicines and the people who use them. We continuously monitor safety.

“We believe that by working with the MHRA we have conveyed complete and appropriate information to healthcare professionals and patients about the safe and effective use of monecrust.”

Dr Andy Whittamore, clinical lead at Asthma + Lung UK, said: “Montelukast is generally a very safe medicine. It is important that doctors explain its possible side effects.”