RASILEZ (aliskiren) and RASILEZ HCT (aliskiren/hydrochlorothiazide) - Potential Risks of Cardiovascular and Renal Adverse Events in Patients with Type 2 Diabetes - For the Public

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Contact: Marketed Health Products Directorate

The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Novartis Pharmaceuticals Canada Inc. Contact the company for a copy of any references, attachments or enclosures.

PUBLIC COMMUNICATION
Health Canada Endorsed Important Safety Information on RASILEZ (aliskiren) and RASILEZ HCT (aliskiren/hydrochlorothiazide)

January 23, 2012

Subject: Potential risks of cardiovascular and renal adverse events in patients with type 2 diabetes treated with aliskiren (RASILEZ*) or aliskiren/hydrochlorothiazide (RASILEZ HCT*).

Novartis Pharmaceuticals Canada Inc. ("Novartis"), in collaboration with Health Canada, would like to inform you about important new safety information for aliskiren-containing products, RASILEZ* and RASILEZ HCT*, following interim results review from a clinical study ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints). Interim results indicated a higher frequency of non-fatal strokes, serious renal complications, hyperkalemia (high potassium levels in the blood) and hypotension (low blood pressure) in patients treated with aliskiren.

Aliskiren (RASILEZ*) is a medication that helps to reduce hypertension (high blood pressure). It can be used alone or in combination with selected other agents such as thiazide diuretics, angiotensin converting enzyme inhibitors, angiotensin II AT1 receptor blockers or dihydropyridine calcium channel blockers. Aliskiren and hydrochlorothiazide (RASILEZ HCT*) are also indicated to treat hypertension.

Analyses of the ALTITUDE interim results are still ongoing. Until further analyses are available, the treatment of patients with type 2 diabetes taking RASILEZ* or RASILEZ HCT should be revised as early as possible using the following advice:

Novartis has also sent a letter to all healthcare professionals to inform them of this new safety information. A copy of that letter is available on the Health Canada website.

Call for Reporting

You should report any suspected adverse reactions associated with use of RASILEZ* or RASILEZ HCT* to Health Canada (See below). Adverse reaction should also be reported to Novartis Pharmaceuticals Canada Inc. (See below).

Should you have any questions or require additional information regarding the use of RASILEZ* (aliskiren) or RASILEZ HCT* (aliskiren and hydrochlorothiazide), please contact Novartis Pharmaceuticals Canada Inc., Medical Information Department at 1-800-363-8883.

Sincerely,

original signed by

Jean-Marie Leclerc, M.D. FRCP(C)
Chief Scientific Officer and Senior Vice-President Clinical and Regulatory Affairs

*RASILEZ and RASILEZ HCT are registered trademarks