April 20th, 2012

Aliskiren (Tekturna) Gets New Warning and Contraindication from FDA

The FDA has issued new warnings about antihypertensive drugs containing the direct renin inhibitor aliskiren (including Tekturna, Amturnide, Takamio, and Valturna) when used in combination with ACE inhibitors or angiotensin-receptor blockers (ARBs). The FDA now states that these drug combinations are contraindicated in patients with diabetes, and it is adding a new warning to avoid the use of this combination in patients with moderate to severe renal impairment (GFR <60 mL/min).

The new warnings are based on preliminary data from the ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints) clinical trial. As previously reported here, ALTITUDE was terminated last December when the independent Data Monitoring Committee (DMC) found an increased risk for nonfatal stroke, renal complications, hyperkalemia, and hypotension in patients taking aliskiren after a median follow-up of about 27 months. More than 8500 patients  with type 2 diabetes and renal disease were randomized to receive aliskiren or placebo in addition to an ACE inhibitor or an ARB.

Click here to read the FDA Drug Safety Communication.

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