喘息患者が青い吸入器の過剰使用による重篤な発作のリスク増大について警告される

This announcement serves as a reminder regarding updates to product information and the guidance from the National Institute for Health and Care Excellence (NICE) pertaining to short-acting beta 2 agonists (SABAs), such as salbutamol and terbutaline, which are utilized to alleviate sudden asthma symptoms including chest tightness, wheezing, coughing, and breathlessness.

Patients should continue to use their prescribed daily preventer inhaler and consult a healthcare professional if they find themselves relying on their blue inhaler more than twice a week.

If asthma symptoms like chest tightness, wheezing, coughing, or breathing difficulties worsen or do not improve with the blue inhaler, patients are encouraged to seek immediate medical assistance. Any suspected side effects must be reported to the MHRA via the Yellow Card scheme.

Dr. Alison Cave, Chief Safety Officer at the MHRA, stated:

“The safety of patients is our utmost concern, and we continuously monitor all medications to ensure that their benefits outweigh any associated risks.

“Patients should adhere to the usage of their preventer inhaler as directed by their healthcare provider, even if their asthma appears to be under control. Blue inhalers serve a critical role in managing symptoms during an asthma attack but should not be the sole method for asthma management.

“We recommend that patients consult with a healthcare professional if they find themselves having to use their blue inhaler more than twice a week. Preventer inhalers should be utilized as prescribed, even when symptoms seem manageable.

“Should asthma symptoms worsen or remain unrelieved by their blue inhaler, patients are advised to seek urgent medical assistance. Any suspected side effects must be reported through our Yellow Card scheme.”

Guidance for asthma patients:

• Utilize your preventer inhaler as prescribed, even if your asthma seems controlled and the blue inhaler is seldom or never required. Inadequate use of a preventer inhaler may lead to worsening symptoms and increase the likelihood of severe asthma attacks.
• If prescribed a blue inhaler for use during asthma attacks, you should also receive a separate preventer inhaler for daily use.
• Adhere to your asthma action plan, or consult your healthcare professional, if you need your blue inhaler more than twice a week – this may signify that your asthma is not adequately controlled.
• If your blue inhaler lacks a dose counter, keep a manual record of doses used, and ensure you have a spare inhaler available before your current one runs out or expires.
• Seek immediate medical attention if your symptoms are not alleviated by your blue inhaler, such as experiencing chest tightness, wheezing, coughing, or difficulty in breathing.
• Your healthcare provider can offer advice on recommended alternative or additional treatments (beyond the blue inhaler) for individuals over 12 years of age with poorly managed asthma.

Notes for editors:

• The MHRA has published a Drug Safety Update aimed at healthcare professionals to remind them of the risks associated with the overuse of blue inhalers, which includes a comprehensive summary of the evidence and updates on asthma prescribing guidelines.
• NICE unveiled updated national asthma guidance (NG245) in November 2024, which no longer endorses prescribing short-acting beta 2 agonists (SABA) alone for any age demographic. The latest recommendations advocate for the majority of patients to be treated with combination inhalers that include both preventer (anti-inflammatory) and reliever medications as part of Anti-inflammatory Reliever (AIR) or Maintenance and Reliever Therapy (MART).
• The MHRA updated the UK product information for SABAs in 2024 to enhance warnings regarding the risk of asthma deterioration associated with SABA overuse, which is reflected in the revised Summaries of Product Characteristics (SmPC) for salbutamol そして terbutaline.
• A December 2024 report from the UK National Child Mortality Database (NCMD) revealed that 87% (47 out of 54) of children who succumbed to asthma had received three or more SABA inhalers in the past year, indicating a known link between having three or more SABA prescriptions within a year and experiencing severe asthma exacerbations across all asthma severity levels.
• The Medicines and Healthcare Products Regulatory Agency (MHRA) is accountable for regulating all medications and medical devices in the UK by ensuring their efficacy and safety. All our operations are based on solid and fact-based judgments to ensure that benefits are justified against any potential risks.
• The MHRA operates as an executive agency of the Department of Health and Social Care.
• について Yellow Card scheme is the MHRA’s system for monitoring the safety of medicines within the UK, serving as an early warning mechanism to identify new safety information about medications and to strengthen existing information. Yellow Cards work alongside other scientific safety data to support the MHRA in taking necessary actions to amend warnings associated with medications or to re-evaluate the usage of those medications to enhance patient benefits while minimizing risks.
• For media inquiries, please contact the newscentre@mhra.gov.uk, or call 020 3080 7651.