Drug Safety Update: ACE-inhibitors

The product information for all 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. 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.

• although uncommon or rare, angioedema (swelling of the face, lips, tongue, or throat) can occur at any time while taking an ACE inhibitor, even if you have been taking it for a long period without problems
• seek urgent medical attention if you develop swelling of the face, lips, tongue, or throat, or experience difficulty breathing or swallowing whilst taking ACE inhibitors
• do not take further doses of your ACE inhibitor if angioedema is suspected and inform a healthcare professional immediately
• inform healthcare professionals if you have ever experienced angioedema, including while taking an ACE inhibitor.  Please be aware that angioedema can occur for other reasons, and a healthcare professional may still recommend an ACE inhibitor for you in these instances