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FDA warns about new risks of aliskiren-containing drugs
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The FDA today issued a warning about possible risks of aliskiren-containing drugs when used in combination with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in certain patient populations.
Specifically, the agency said these drug combinations are contraindicated in patients with diabetes and that their use should also be avoided in patients with moderate to severe renal impairment (glomerular filtration rate ,60 mL/minute). Labels for drugs containing aliskiren are being updated based on preliminary data from the Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE) trial.
In ALTITUDE, risks for renal impairment, hypotension and hyperkalemia in a group of patients taking aliskiren plus an ARB or ACE inhibitor increased relative to a group of patients taking placebo plus an ARB or ACE inhibitor. Preliminary data from ALTITUDE also demonstrated a slight excess of CV events, including death or stroke, in the aliskiren group. The FDA, however, has not definitely concluded that an actual link between these drugs and death or stroke exists. The agency will evaluate the final trial results as well as results from other aliskiren trials and will communicate any new information when available.