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

Starting date:

January 23, 2012

Posting date:

January 23, 2012

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-190001041

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

Notice about Health Canada advisories

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:

• RASILEZ* and RASILEZ HCT* should not be used with the other classes of medications for the treatment of hypertension called angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB) in patients with type 2 diabetes, therefore:
  • Talk to your doctor if you are taking RASILEZ* or RASILEZ HCT* and if you have type 2 diabetes
  • Your doctor should not prescribe RASILEZ* or RASILEZ HCT* if you have type 2 diabetes and you are also taking either an ACE inhibitor or ARB
• You should NOT stop any of these treatments before discussing with your doctor

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).

Novartis Pharmaceuticals Canada Inc.
385 Bouchard blvd,
Dorval, Quebec, H9S 1A9
Phone: 1-800-363-8883 (Medical Information)

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Report online at MedEffect^TM Canada
• Call toll-free at 1-866-234-2345
• Complete a Reporting Form and:
  • Fax toll-free to 1-866-678-6789, or
  • Mail to: Canada Vigilance Program
    Health Canada
    Postal Locator 0701E
    Ottawa, Ontario K1A 0K9

The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect^TM Canada Web site in the Adverse Reaction Reporting section.

For other health product inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

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