The FDA has released new warnings regarding combining aliskiren (Tekturna) with ACE inhibitors or ARBs in patients with diabetes or renal impairment. Aliskiren is a renin inhibitor indicated for the treatment of hypertension. Aliskiren is found in the following medications:
The labels for all medications containing aliskiren are being updated based on preliminary data from the clinical trial “Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE).” In ALTITUDE, the risks of renal impairment, hypotension, and hyperkalemia in the group of patients taking aliskiren plus an ARB or ACEI increased relative to the placebo plus ARB or ACEI group. The preliminary data from ALTITUDE also demonstrated a slightly higher risk of stroke (2.7% aliskiren vs. 2.0% placebo) and death (6.9% aliskiren vs. 6.4% placebo) in aliskiren-treated patients. At this time, however, the FDA has reached no conclusion regarding a link between aliskiren treatment and these cardiovascular-related events. The 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 are being added to the drug labels for aliskiren-containing products as of 4/20/12:
Posted on April 25, 2012
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