Aliskiren and angioedema

Editor, – Aliskiren is a novel antihypertensive drug that is an orally-active direct renin inhibitor (Aust Prescr 2009;32:132-5). Its action shares a common biological pathway with angiotensin-converting enzyme (ACE) inhibitors. However, it has been suggested in an article by Professor Duggan that some respiratory and vascular adverse events were less likely than with the older drugs (Aust Prescr 2009;32:135-8). The proposal was fairly reasonable based on the different molecular target of the two drug groups. However, post marketing experience revealed cases of aliskiren-associated angioedema and drug regulators implemented labelling changes and safety advice.^1-3 Therefore, physicians should be vigilant for the first signs of angioedema in aliskiren users. The biological basis, exact frequency and risk factors of this potentially life-treating event are currently not well understood. Until evidence becomes available, aliskiren and probably other similar drugs should not be used in patients with previous episodes of ACE inhibitor-induced angioedema of any clinical presentation.

Dragan Milovanovic, Slobodan Jankovic, Dejana Ruzic Zecevic and Marko Folic
Department of Clinical Pharmacology, Medical Faculty and University Hospital
Kragujevac, Serbia

Associate Professor K Duggan, author of the article, comments:

The true incidence of adverse effects often only becomes apparent after the drug has been marketed and my article was prepared before marketing. De novo angioedema as an adverse effect of the angiotensin receptor antagonists only became apparent post marketing and the same appears to be occurring with aliskiren. Contraindications to the use of aliskiren should now include angioedema occurring as a consequence of the use of other renin-angiotensin drugs. This scenario highlights the importance of practitioners notifying regulatory bodies of adverse effects not previously reported.