Safety advice on particular drugs or classes of drugs
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| Canada: Rasilez (aliskiren) and Rasilez HCT (aliskiren／hydrochlorothiazide) - Potential risks of cardiovascular and renal adverse events in patients with Type 2 diabetes |
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Novartis Pharmaceuticals Canada Inc., in collaboration with Health Canada, would like to inform healthcare professionals about important new safety information for aliskiren-containing products following interim results review from the Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE). Interim results indicated a higher incidence of non-fatal strokes, renal complications (end stage renal disease and renal death), hyperkalemia and hypotension in aliskiren-treated patients. Rasilez is currently authorized in Canada for use either alone or in combination with other drugs including angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) for the treatment of essential hypertension. Analyses of the ALTITUDE interim results from the ALTITUDE study are ongoing. However, pending further analyses, a contra-indication in patients with diabetes taking an ACE inhibitor or an ARB is now advised. The treatment of diabetic patients taking aliskiren-containing products should therefore be reviewed, taking the following advice into consideration:
a. aliskiren or aliskiren-containing fixed combination products should not be used in combination with ACE inhibitors or ARBs in patients with diabetes, therefore:
i. healthcare professionals should stop aliskiren-containing treatment in patients who are diabetic and also taking an ACE inhibitor or an ARB. Alternative antihypertensive treatment should be considered if necessary, and
ii. treatment with aliskiren-containing products should not be initiated in diabetic patients who are also taking either an ACE inhibitor or ARB,
b. patients should NOT stop any of these treatments before discussing with a healthcare professional.
As additional analyses from ALTITUDE are ongoing, the Canadian Product Monograph will be updated in 2012.
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/rasilez_hpc-cps-eng.php
In Hong Kong, Aliskiren is indicated for treatment of essential hypertension. There are 10 registered pharmaceutical products containing aliskiren, namely, Rasilez Tab 300mg (HK-56440), Rasilez Tab 150mg (HK-56441), Rasilez HCT Tab 150/25mg (HK-59014), Rasilez HCT Tab 300/12.5mg (HK-59015), Rasilez HCT Tab 150/12.5mg (HK-59016), Rasilez HCT Tab 300/25mg (HK-59017), Rasilez Tab 150mg (Italy) (HK-60309), Rasilez Tab 300mg (Italy) (HK-60310), Rasival Tab 300/320mg (HK-60789) and Rasival Tab 150/160mg (HK-60790). All of them are registered by Novartis Pharmaceuticals (HK) Ltd., and are prescription-only medicines. Department of Health was informed by Novartis on the early termination of the ALTITUDE study on 20 December 2011. Letter to inform healthcare professionals was issued on 21 December 2011. The news on the ALTITUDE study has been released by the EMA and Health Canada and was posted on the website of Drug Office on 23 December 2011. Department of Health will keep vigilant against any updated safety news of the drug and actions taken by overseas regulatory authorities.
Ends/ Thursday, January 26, 2012
Issued at HKT 12:30 |
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