Other safety alerts
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| Canada: Rasilez (aliskiren): Health Canada reviewing safety of blood-pressure drug |
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In light of the recent company decision (Novartis press release) to stop a multi-national clinical trial known as the ALTITUDE study, Health Canada is informing Canadians that it is reviewing the safety of the prescription blood-pressure drug Rasilez (the brand name for aliskiren). The ALTITUDE study (ALiskiren Trial In Type 2 diabetes Using cardio-renal Disease Endpoints) was investigating if Rasilez could reduce the risk of cardiovascular (heart-related) and renal (kidney) events when added to conventional therapies in patients with diabetes and kidney impairment. In the study, Rasilez was given in addition to other blood-pressure lowering drugs. Novartis terminated the study after interim data suggested that Rasilez was unlikely to benefit these patients participating in the clinical trial and could potentially lead to harm. Specifically, when used in combination with other blood pressure -lowering drugs known as angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), Rasilez was associated with an increased risk of non-fatal stroke, kidney complications, hyperkalemia (high levels of potassium in the blood) and low blood pressure. Rasilez is currently authorized in Canada for use either alone or in combination with other drugs including ACE-inhibitors and ARBs to control high blood pressure.
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_175-eng.php
Situation 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 Pharmaceuticals (HK) Ltd. on the early termination of the ALTITUDE study on 20 December 2011. Letter to inform healthcare professionals was issued on 21 December 2011. Department of Health will keep vigilant against any updated safety news of the drug and actions taken by overseas regulatory authorities.
Ends/Friday, December 23, 2011
Issued at HKT 12:00
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