Warn patients about delayed onset reaction to ACE inhibitors, MHRA advises
GPs should advise patients taking ACE inhibitors about a rare side effect that can happen even if they have been taking the drug for weeks or even years.
Information on packaging is also being strengthened to increase awareness of the potential for angioedema related to ACE inhibitors, the drugs regulator said.
In a drug safety update, the Medicines and Healthcare products Regulatory Agency (MHRA) said clinicians needed to be aware of the risk of delayed-onset angioedema in those taking the medicines.
Analysis of Yellow Card data found that around one-half of angioedema cases occurred 30 days or more after starting the medication – higher than the 20-30% indicated by drugs manufacturers.
The delayed-onset pattern is more associated with the non-allergic bradykinin-mediated angioedema, the MHRA said.
Health professionals need to be aware of this mechanism of action, as bradykinin-mediated angioedema is unlikely to respond to standard anaphylaxis treatments including adrenaline, the update noted.
The blood pressure medicines are among the most frequently prescribed drugs in the UK.
Patients need to be aware that angioedema can occur at any time during treatment, the MHRA said.
It presents as 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, the update said.
Those taking the medications should be advised that if they have any swelling in the face, lips, tongue or throat they should seek medical attention immediately and take no further doses.
Fatal cases, although rare, have involved airway compromise and have occurred after prolonged ACE inhibitor treatment, it added.
If angioedema is suspected in a patient taking an ACE inhibitor, the drug should be discontinued immediately and not restarted.
Older adults, women, people who smoke and patients of Black or African Caribbean ethnicity, may be at increased risk, the MHRA advised.
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