Canada Issues Warning, Updates Labeling For Rasilez

Canada just issued a warning for Rasilez, a high blood pressure drug known as Tekturna in the United States. Novartis Pharmaceuticals, Canada Inc makes Rasilez.

Health Canada and Novartis issued the warning for aliskiren-containing products, Rasilez and Rasilez HCT, after an interim results review of the clinical study ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints) revealed 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.

Tekturna and Rasilez help reduce hypertension (high blood pressure) and 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 interim results continue and, until further analyses are available, treatment of Type 2 diabetes patients taking Rasilez or Rasilez HCT should be revised as early as possible:

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.
Patients are advised to speak to their physicians if taking these medications and diagnosed with Type 2 diabetes, and should not stop any of these treatment before speaking to their doctors.
Physicians should not prescribe Rasilez or Rasilez HCT to Type 2 diabetes patients who are also taking either an ACE inhibitor or ARB.

Novartis has contacted healthcare professionals, by letter, informing them of this new safety information; the letter is available on the Health Canada website. Adverse reactions associated with Rasilez or Rasilez HCT should be reported to Health Canada and Novartis Pharmaceuticals Canada Inc. Novartis’ Medical Information Department can be reached, toll-free, at 1.800.363.8883.

In the U.S., Tekturna is in a class of drugs known as direct rennin inhibitors and is intended to reduce the body’s production of the enzyme renin, which has been shown to increase blood pressure. When blood pressure increases to high levels, the pressure forces the heart to work harder, increasing death risks from heart disease and stroke.

As we previously wrote, the European Medicines Agency (EMA) announced it was initiating a review of aliskiren’s benefits and risks and had advised doctors to stop prescribing the medication to diabetic patients taking ACE inhibitors or ARBs. Also, a study published in the American Journal of Hypertension in 2007 and conducted at Weill Medical College of Cornell University in New York, called into question the drug’s efficacy. The authors concluded that aliskiren was no more effective than angiotensin-converting enzyme inhibitors (CEIs), ARBs, or diuretics for lowering blood pressure.

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