Aliskiren-containing Medications: New Warnings and Contraindications

Drug Alerts , News / September 30, 2016

The FDA notified healthcare professionals of possible risks when using high blood pressure medicines containing aliskiren concomitantly with angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney impairment.

These drugs combinations are contraindicated in patients with diabetes because of the risk of renal impairment, hypotension, and hyperkalemia.  Additionally, the use of aliskiren with ARBs or ACEIs in patients with moderate to severe renal impairment (i.e. where glomerular filtration rate [GFR] >60 ml/min) should be avoided.

The labels for the aliskiren drugs are being updated based on preliminary data from a clinical trial, Aliskiren Trial in Type II Diabetes Using Cardio-Renal Endpoints (ALTITUDE).

Aliskiren is a renin inhibitor used to treat high blood pressure.

Patients should not stop taking aliskiren without talking to their healthcare professional. Stopping aliskiren suddenly can cause problems if a patient’s hypertension is not controlled.

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