Safety advice on particular drugs or classes of drugs
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| European Union: European Medicines Agency recommends new contraindications and warnings for aliskiren-containing medicines – they should be contraindicated in patients with diabetes or moderate to severe renal impairment who take angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) |
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The European Medicines Agency (EMA) finalised a review of aliskiren-containing medicines, recommending that these medicines should be contraindicated in patients with diabetes or moderate to severe renal impairment who take angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). In addition, the Agency recommended the inclusion of a warning that the combination of aliskiren and ACE inhibitor or ARB is not recommended in all other patients because adverse outcomes cannot be excluded.
EMA advised doctors should stop prescribing aliskiren-containing medicines to patients with diabetes (type 1 or type 2) or with moderate to severe kidney impairment who are also taking an ACE inhibitor or ARB, and should consider alternative antihypertensive treatment as necessary.
The EMA recommendations follow a review by the Agency’s Committee for Medicinal Products for Human Use. The review was started in December 2011 after EMA was informed by the marketing authorisation holder of the decision to terminate the ALTITUDE study early. Information available to-date suggest a risk of adverse outcomes (hypotension, syncope, stroke, hyperkalaemia and changes in renal function, including acute renal failure) when aliskiren is combined with ACE inhibitors or ARBs, especially in diabetic patients and those with impaired renal function. Although less evidence is available for other patient groups, adverse outcomes cannot be excluded and therefore the Committee no longer recommends the use of this combination.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/02/news_detail_001446.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, aliskiren is indicated for treatment of essential hypertension. There are 10 registered pharmaceutical products containing aliskiren and are prescription-only medicines. Department of Health was informed by Novartis on the early termination of the ALTITUDE study on 20 December 2011 and a letter to inform healthcare professionals was issued on 21 December 2011.
News relating to the ALTITUDE study from EMA/UK Medicines and Healthcare Products Regulatory Agency, Health Canada and Singapore’s Health Sciences Authority were posted on the website of Drug Office on 23 December 2011, 26 January 2012 and 31 January 2012 respectively. Letter to healthcare professionals will be issued. The matter will be discussed in the Registration Committee of the Pharmacy and Poisons Board and Department of Health will keep vigilant against any updated safety news from other overseas regulatory authorities.
Ends/ Saturday, February 18, 2012
Issued at HKT 12:30 |
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