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Product information for all angiotensin converting enzyme (ACE) inhibitors is being updated to strengthen the warnings on the risk of delayed-onset angioedema, which may still occur after weeks to years of use. 

Angioedema is a known uncommon or rare side-effect of ACE inhibitor treatment. This can either be allergic (histamine-mediated) or less commonly non-allergic (bradykinin-mediated). It can occur at any time during treatment, including after weeks to years of use.

Clinical features include swelling of the tongue, lip, face, or larynx, which may cause difficulty in breathing or swallowing may progress and can lead to airway compromise. Other symptoms can include gastrointestinal pain and cramps.

Bradykinin-mediated angioedema is unlikely to respond to standard anaphylaxis treatments including adrenaline (epinephrine). The MHRA advises that lack of response to standard anaphylaxis treatments should prompt consideration of bradykinin-mediated angioedema.

If angioedema is suspected in a patient taking an ACE inhibitor, treatment should be discontinued immediately and not restarted.

Pharmacists should advise people that:

• Although uncommon or rare, angioedema can occur at any time while taking an ACE inhibitor, even if they have been taking it for a long period without problems
• They should seek urgent medical attention if they develop swelling of the face, lips, tongue, or throat, or experience difficulty breathing or swallowing whilst taking ACE inhibitors
• They should not take any further doses of the ACE inhibitor if angioedema is suspected and they should inform a healthcare professional immediately
• They should inform healthcare professionals if they have ever experienced angioedema, including while taking an ACE inhibitor.

The MHRA is implementing updates to the summary of product characteristics and patient information leaflets in a phased approach. They will be updated to strengthen warnings and improve communication on the risk of delayed-onset angioedema and the potential for standard anaphylaxis treatments to be ineffective. These updates are currently in progress and will be implemented over the coming months, the MHRA said.