OFFICIAL-SOURCE RECALL · UNITED KINGDOM
MHRA Safety Roundup: June 2026 Recall: of delayed-onset angioedema, which may still occur
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- MHRA Safety Roundup: June 2026
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Why this product was recalled
of delayed-onset angioedema, which may still occur after weeks to years of use. Healthcare professionals, particularly in emergency departments, should be aware of the potential for delayed onset of angioedema and the distinction between bradykinin- and histamine-mediated cases, as treatment strategies differ significantly and bradykinin-mediated angioedema does not respond to standard treatment. Key Advice for Healthcare Professionals 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). Healthcare professionals should consider bradykinin-mediated mechanisms as a cause when standard anaphylaxis treatment is ineffective angioedema can occur at any time during treatment, including after weeks to years of use 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) lack of response to stand
Hazard
of delayed-onset angioedema, which may still occur after weeks to years of use. Healthcare professionals, particularly in emergency departments, should be aware of the potential for delayed onset of angioedema and the distinction between bradykinin- and histamine-mediated cases, as treatment strategies differ significantly and bradykinin-mediated angioedema does not respond to standard treatment. Key Advice for Healthcare Professionals 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). Healthcare professionals should consider bradykinin-mediated mechanisms as a cause when standard anaphylaxis treatment is ineffective angioedema can occur at any time during treatment, including after weeks to years of use 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) lack of response to stand
Official recall notice
MHRA Safety Roundup: June 2026
Agency: Medicines and Healthcare products Regulatory Agency
Official publication date: June 30, 2026
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