Aliskiren (Rasilez▼): risk of angioedema and renal dysfunction
- Medicines and Healthcare products Regulatory Agency
- 1 May 2009
- Therapeutic area:
- Cardiovascular disease and lipidology and Urology and nephrology
Use of aliskiren can cause angioedema, a rare and serious side effect, and or acute renal failure.
Article date: May 2009
Aliskiren (Rasilez▼) is the first of a new class of medicine that directly inhibits renin. Aliskiren is used for the management of high blood pressure, at a recommended dose of 150mg once daily; in patients whose blood pressure is not adequately controlled, the dose may be increased to 300mg once daily.
Angioedema (a serious allergic reaction that causes swelling of the face or throat and occasionally other areas such as the hands) can occur as a rare and serious side-effect of treatment with aliskiren. It can develop rapidly, and can be dangerous if it affects the throat because it can lead to obstruction of the airway.
The European Medicines Agency recommends new contraindication and warning for rasilez and other aliskiren medicines.
Acute renal failure
There have been reports of acute renal failure in patients with risk factors for renal dysfunction (including hypovolaemia, heart disease, liver disease, or kidney disease). Furthermore, there is an increased risk of renal insufficiency, including acute renal failure, when patients with renal artery stenosis are treated with aliskiren.
Use with NSAIDs
Non-steroidal anti-inflammatory drugs (NSAIDs) may reduce the antihypertensive effect of aliskiren. In some patients with compromised renal function (eg, dehydrated or elderly patients) aliskiren given concomitantly with NSAIDs may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible when treatment is stopped.
Advice for healthcare professionals explains:
- aliskiren should not be used for the management of high blood pressure in patients who have previously had angioedema when using it
- patients should be advised that they should stop aliskiren and seek medical advice straight away if they develop symptoms of angioedema, such as swelling of the face, eyes, lips or tongue (or both), hands and feet, or difficulty breathing or swallowing
- extreme caution is required if aliskiren is used in patients with renal artery stenosis or conditions predisposing to kidney dysfunction (such as hypovolaemia, heart disease, liver disease, or kidney disease) because of a risk of acute renal failure - if any signs of renal failure occur, aliskiren should be promptly discontinued
- NSAIDs may reduce the antihypertensive effect of aliskiren
- elderly patients or patients with compromised renal function may be at risk of further deterioration of renal function if NSAIDs and aliskiren are used together
Article citation: Drug Safety Update May 2009, vol 2 issue 10: 2.
Published: 1 May 2009