Department of Health and Social Care
Central Government
Action Planned
AI-generated response summary
The MHRA plans to formally review product information for all steroid injection licenses by the end of the year to ensure consistent anaphylaxis warnings and will assess the need for further communications to healthcare professionals. The Department of Health and Social Care is also reviewing recommendations from the National Allergy Strategy regarding improved allergy care and drug allergy recording.
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Dear Ms Hassell, Thank you for the Regulation 28 report of 8 July sent to the Department of Health and Social Care about the death of June Turner. I am replying as the duty Minister. Firstly, I would like to say how saddened I was to read of the circumstances of June’s death, and I offer my sincere condolences to their family and loved ones. The circumstances your report describes are concerning and I am grateful to you for bringing these matters to my attention. Your report raises concerns over the lack of clinical guidance regarding the risk of severe life- threatening reactions following the administration of steroid injections. In preparing this response, my officials have made enquiries with the Medicines and Healthcare products Regulatory Agency (MHRA) to ensure we adequately address your concerns. The MHRA functions to regulate medicines, including vaccines, supplied in the UK. The Agency’s activity spans the whole of a medicine’s lifecycle. The MHRA ensures that medicines are efficacious and acceptably safe, and that any possible side effects are appropriately described in the authorised product information of that medicine. This information comprises the Summary of Product Characteristics (SmPC, intended for healthcare professionals), labelling, and Patient Information Leaflet (PIL, provided to patients in each medicine pack). The SmPC is a source of advice for healthcare professionals on the safe and effective use of a medicinal product. Currently, most steroid products in the UK contain a warning within section 4.8 of the SmPC regarding the adverse drug reaction (ADR) of anaphylaxis. These warnings are mirrored in most PIL of steroid products. Anaphylactic reactions related to steroid use are rare. Based on the available evidence, corticosteroids remain a safe class of medicines which are vital for the treatment of several conditions.
[Page 2] Nevertheless, MHRA plan to begin formally reviewing the product information for all steroid injection licenses by the end of this year, to ensure that the ADRs and warnings listed for anaphylaxis are appropriately present and consistent in terminology. This will ensure alignment with information resources from other stakeholders such as the NHS, available here: Side effects of hydrocortisone injections - NHS. The exact time frame for publishing any required communications following this will depend on the findings of the product information review, and whether the manufacturers of these products need to be contacted to amend any text. The MHRA will seek to action any required updates, as soon as possible. Further communications to remind prescribers and healthcare professionals of the potential for anaphylactic reactions to steroid injections could be useful, especially considering the nature of their indicated use. Therefore, the MHRA will assess by the end of the year whether updates to healthcare professionals are needed, and that any agreed communications are actioned accordingly. The MHRA takes reports from healthcare professionals, patients and stakeholders seriously. The MHRA will continue to monitor for any adverse trends concerning this matter and will respond in a risk proportionate manner if any further issues come to our attention. Further to this the Government acknowledges the need for improved allergy care and support and is committed to ensuring that people with allergies receive high-quality care. We recognise that allergies can be serious, and in some cases, life-threatening. The National Institute for Health and Care Excellence (NICE) has published guidance on the diagnosis and management of drug allergies. The guidance includes recommendations on documenting and sharing information on a patient’s allergies with other healthcare professionals. As a minimum, information on the drug name, the signs, symptoms and severity of the reaction, and the date when the reaction occurred, should be documented on a person’s medical record. Healthcare professionals should always check a person’s allergy and confirm it with them (or their family members or carers as appropriate) before prescribing, dispensing or administering any drug. The National Allergy Strategy Group published its National Allergy Strategy in April 2026. The strategy was developed by a wide range of allergy stakeholders and presented to the Government to take forward many of its recommendations. The strategy includes recommendations on drug allergy. In particular, it recommends establishing an expert strategic panel to promote improvements in the recording of drug allergy in medical records and national NHS systems. The Department of Health and Social Care is thoroughly reviewing all the recommendations included in the National Allergy Strategy and carefully considering the feasibility and viability of implementing each of the recommendations attributed to government departments or arm’s length bodies.
[Page 3] I hope this response is helpful. Thank you for bringing these concerns to my attention. I am committed to improving patient safety and it remains at the heart of our health service.
[Page 2] Nevertheless, MHRA plan to begin formally reviewing the product information for all steroid injection licenses by the end of this year, to ensure that the ADRs and warnings listed for anaphylaxis are appropriately present and consistent in terminology. This will ensure alignment with information resources from other stakeholders such as the NHS, available here: Side effects of hydrocortisone injections - NHS. The exact time frame for publishing any required communications following this will depend on the findings of the product information review, and whether the manufacturers of these products need to be contacted to amend any text. The MHRA will seek to action any required updates, as soon as possible. Further communications to remind prescribers and healthcare professionals of the potential for anaphylactic reactions to steroid injections could be useful, especially considering the nature of their indicated use. Therefore, the MHRA will assess by the end of the year whether updates to healthcare professionals are needed, and that any agreed communications are actioned accordingly. The MHRA takes reports from healthcare professionals, patients and stakeholders seriously. The MHRA will continue to monitor for any adverse trends concerning this matter and will respond in a risk proportionate manner if any further issues come to our attention. Further to this the Government acknowledges the need for improved allergy care and support and is committed to ensuring that people with allergies receive high-quality care. We recognise that allergies can be serious, and in some cases, life-threatening. The National Institute for Health and Care Excellence (NICE) has published guidance on the diagnosis and management of drug allergies. The guidance includes recommendations on documenting and sharing information on a patient’s allergies with other healthcare professionals. As a minimum, information on the drug name, the signs, symptoms and severity of the reaction, and the date when the reaction occurred, should be documented on a person’s medical record. Healthcare professionals should always check a person’s allergy and confirm it with them (or their family members or carers as appropriate) before prescribing, dispensing or administering any drug. The National Allergy Strategy Group published its National Allergy Strategy in April 2026. The strategy was developed by a wide range of allergy stakeholders and presented to the Government to take forward many of its recommendations. The strategy includes recommendations on drug allergy. In particular, it recommends establishing an expert strategic panel to promote improvements in the recording of drug allergy in medical records and national NHS systems. The Department of Health and Social Care is thoroughly reviewing all the recommendations included in the National Allergy Strategy and carefully considering the feasibility and viability of implementing each of the recommendations attributed to government departments or arm’s length bodies.
[Page 3] I hope this response is helpful. Thank you for bringing these concerns to my attention. I am committed to improving patient safety and it remains at the heart of our health service.