Key Summary
- MHRA has updated safety warnings across all ACE inhibitors following a comprehensive data review.
- The MHRA advises healthcare professionals to distinguish between allergic and non-allergic angioedema.
- If angioedema is suspected in any patient taking an ACE inhibitor, the medication must be discontinued immediately and permanently marked as a contraindication.
The Medicines and Healthcare products Regulatory Agency (MHRA) has updated safety warnings across all ACE inhibitors following a comprehensive data review.
ACE inhibitors (Angiotensin-Converting Enzyme inhibitors) are a widely prescribed class of medications primarily used to relax blood vessels, lower blood pressure, and improve overall blood flow.
They are prescribed to treat hypertension, heart failure, post-myocardial infarction management, diabetic nephropathy, and cardiovascular risk reduction.
In rare cases, angioedema (severe swelling of the face, lips, tongue, or throat) can occur ACE inhibitor treatment. This side effect may be belated, occurring after weeks, months, or even years of trouble-free use.
A review of UK Yellow Card data up to 10 June 2026 confirmed the high prevalence of delayed reactions, revealing that approximately half of all reported angioedema cases with a known time-to-onset occurred 30 days or more after starting the drug.
The MHRA has advised healthcare professionals to distinguish between allergic (histamine-mediated) and non-allergic (bradykinin-mediated) angioedema, as their treatment protocols differ significantly.
Bradykinin-mediated angioedema is unlikely to respond to standard allergy interventions, including adrenaline (epinephrine), steroids, or antihistamines. A lack of response should immediately prompt clinicians to initiate specific bradykinin clinical protocols.
Swelling may rapidly progress to involve the larynx, causing life-threatening airway compromise. Patients may also present with "hidden" symptoms, such as severe gastrointestinal pain and abdominal cramps.
If angioedema is suspected in any patient taking an ACE inhibitor, the medication must be discontinued immediately and permanently marked as a contraindication.
The MHRA is updating the Summary of Product Characteristics and Patient Information Leaflets in a phased manner.
