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MHRA issues safety warning on overuse of SABA inhalers

MHRA issues safety warning on overuse of SABA inhalers
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The drugs regulator has issued a warning to healthcare professionals not to prescribe salbutamol or terbutaline inhalers without an inhaled corticosteroid.

A drug safety update from the Medicines and Healthcare products Regulatory Agency said short-acting beta 2 agonists (SABA) should not be prescribed to patients of any age unless there was a ‘concomitant prescription of an inhaled corticosteroid’ in line with updated NICE guidance.

All patients with asthma should receive ‘optimal anti-inflammatory maintenance therapy even when their asthma is well controlled’, the MHRA continued.

And anyone who needs to use their blue inhaler more than twice a week should be reviewed and their treatment adjusted, the safety update said.

Urgent reviews should be done for anyone that has had an increase in requests for SABA prescriptions or who have failed to collect anti-inflammatory maintenance treatment that has been prescribed to them, the regulatory said

Warnings were also issued to patients to avoid overusing their SABA or blue inhalers who should be contacting their GP if they find themselves needing them more than twice a week.

The safety update follows the long-awaited joint NICE, BTS and SIGN guidelines published in November.

It set out significant changes to previous treatment approaches, including replacing the use of SABA alone with combined inhaled corticosteroid (ICS)/formoterol inhalers.

There were also several clarifications to the diagnostic pathway for asthma.

For highly symptomatic patients, a clear pathway starting with low-dose maintenance and reliver therapy was set out by NICE.

Experts had particularly welcomed the measures to reduce over-reliance on SABA inhalers which had been highlighted as a key driver of poor asthma control.

A report published in December from the UK National Child Mortality Database found that 47 out of 54 children who died from asthma had three or more SABA inhalers dispensed in the previous year.

There is a known association across all asthma severities between having three or more SABA prescriptions in one year and experiencing severe asthma exacerbations, the MHRA said.

The regulator updated UK product information for SABAs in 2024 to strengthen warnings on the risk of SABA overuse.

Dr Alison Cave, chief safety officer at the MHRA, said: ‘Patient safety is our top priority and we continue to monitor all medicines to ensure their benefits outweigh any risks.

‘Blue inhalers are important for treating symptoms during an asthma attack, but should not be used as the only treatment to manage asthma.

‘We advise patients to speak to a healthcare professional if they find themselves needing their blue inhaler more than twice a week. Preventer inhalers should be taken as prescribed, even when symptoms appear under control.’


          

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READERS' COMMENTS [1]

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Gregory Rose 28 April, 2025 11:00 am

So despite in being only 4 -5 months since the NICE guidelines were even published, MRHA expect all asthmatics to have already been reviewed and had this sorted. Naive in the extreme.