FDA issues warning, contraindication for blood pressure medications containing aliskiren

April 20, 2012

FDA has issued a Drug Safety Communication (April 20) warning of possible risks when using blood pressure medicines containing aliskiren with angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment. These drug combinations are contraindicated in patients with diabetes.

FDA has issued a Drug Safety Communication (April 20) warning of possible risks when using blood pressure medicines containing aliskiren with angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment. These drug combinations are contraindicated in patients with diabetes.

Following discussions with FDA, and the Agency’s review of the preliminary ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints) study data, Novartis has updated the full prescribing information for aliskiren (Tekturna), aliskiren and hydrochlorothiazide (Tekturna HCT), aliskiren and amlodipine (Tekamlo), and aliskiren, amlodipine and hydrochlorothiazide (Amturnide) tablets to include:

• A contraindication against combined use of aliskiren-based products ACE inhibitors or ARBs in patients with diabetes.

• A warning against the use of aliskiren-based products in patients with moderate renal (kidney) impairment (eGFR

The ALTITUDE trial was a multinational study in 8,606 patients from 36 countries evaluating the potential benefits of aliskiren to reduce the risk of cardiovascular and renal events in this patient population. The ALTITUDE trial was the first long-term study to investigate Tekturna in a setting of more than 1 year in patients with type 2 diabetes and renal impairment. These patients were also taking either an ACE inhibitor or ARB and were known to be at high risk for cardiovascular and renal events. 
In December 2011, after a median follow-up of about 27 months, the trial was terminated early for lack of efficacy and higher incidence of adverse events (AE) compared to placebo in this high-risk population. Higher risk of renal impairment, hypotension (low blood pressure), and hyperkalemia (high potassium) was observed in aliskiren- compared to placebo-treated patients. The risk of stroke (2.7% aliskiren vs 2.0% placebo) and death (6.9% aliskiren vs 6.4% placebo) were also numerically higher in aliskiren-treated patients.

Furthermore, and in consultation with FDA, Novartis has voluntarily ceased marketing of aliskiren and valsartan, USP (Valturna) tablets in the United States. Novartis will make Valturna available until July 20, 2012. NPC advises patients to seek guidance from their prescribing healthcare provider at their next (non-urgent) visit, prior to July 20, 2012, to determine appropriate alternate therapy.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.

Download the form or call (800) 332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to (800) FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, here.

Healthcare professionals who require additional information can contact Novartis at (888) 997-5385 or visit www.pharma.us.novartis.com.

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