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Asthma drug under ‘review’ after surge in psychiatric incidents

The medicines watchdog is finalising a review of asthma drug montelukast after a rise in Yellow Card reports, amid a shortage of other asthma drugs. 

The Medicines and Healthcare products Regulatory Agency (MHRA) has been “thoroughly” investigating “the risk of neuropsychiatric reactions” linked to asthma drug montelukast, its chief safety officer Dr Alison Cave has said.

Dr Cave told C+D yesterday (March 6) that the agency is considering “whether any further regulatory action is required”. 

The MHRA added that it is currently finalising its “review” and will communicate the outcome upon completion of the regulatory process.

The news comes as MHRA data has revealed that the number of Yellow Card reports about the psychiatric side effects of the drug skyrocketed last year.

A staggering 143 reports about “psychiatric disorders” related to montelukast were reported in 2023, compared to 103 in 2022 and 100 in 2021.

In a “reminder” published in 2019, the MHRA warned that the drug can cause “sleep disturbances”, depression and agitation, “disturbances of attention or memory” and “very rarely, hallucinations and suicidal behavior”.

It added that “events have been reported in adults, adolescents and children”.


“Limited supply”


Meanwhile, the Department of Health and Social Care (DH) yesterday issued a medicine supply notification warning to healthcare professionals about a shortage of 2.5mg/2.5ml nebuliser liquid unit dose vials of asthma drug salbutamol.

The alert, shared by Community Pharmacy England (CPE), said that the 2.5mg/2.5ml nebules “will be in limited supply from mid-April until late June 2024”.

The DH added that salbutamol 5mg/2.5ml nebules “will remain available” but “cannot support an increase in demand.”

The notification said that “access to licensed salbutamol 2.5mg/2.5ml nebules will be actively monitored and prioritised for primary care”, adding that unlicensed supplies of the drug “can be sourced”.

A national patient safety alert issued by the DH and shared by CPE last week (February 26) said that “supply issues have been caused by a combination of manufacturing issues resulting in increased demand on other suppliers.”

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