FDA Drug Safety Communication

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FDA Date: 4/19/12

Aliskiren Containing Medications FDA Drug Safety Communication

New warning and contraindication for blood pressure medicines containing aliskiren (Tekturna)

The FDA is warning of possible risks when using blood pressure medicines containing aliskiren with other drugs called angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment. These drug combinations should not be used (are contraindicated) in patients with diabetes. In addition, a new warning is being added to avoid use of these drug combinations in patients with kidney impairment. The labels for the aliskiren drugs are being updated based on preliminary data from a clinical trial, "Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE)."

In ALTITUDE, the risks of kidney (renal) impairment, low blood pressure (hypotension), and high potassium blood levels (hyperkalemia) in a group of patients taking aliskiren plus an ARB or ACEI increased relative to a group of patients taking placebo plus an ARB or ACEI. The preliminary data from ALTITUDE also demonstrated a slight excess of cardiovascular events (death or stroke) in the aliskiren group; however, FDA has reached no definite conclusion regarding an actual link between these drugs and death or stroke. FDA will evaluate the final trial results as well as results from other aliskiren trials and will communicate any new information when it becomes available.

The following recommendations have been added to the drug labels for aliskiren-containing products as of 4/20/12:

A new contraindication against the use of aliskiren with ARBs or ACEIs in patients with diabetes because of the risk of renal impairment, hypotension, and hyperkalemia.

A warning to avoid use of aliskiren with ARBs or ACEIs in patients with moderate to severe renal impairment (ie., where glomerular filtration rate [GFR] <60 mL/min).

View the full FDA Drug Safety Communication on FDA.gov