The FDA notified healthcare professionals of possible risks in patients with diabetes or kidney (renal) impairment when using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs). These drug combinations should not be used (are contraindicated) in patients with diabetes. In addition, avoid 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).
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).”
Aliskiren is a renin inhibitor used to treat high blood pressure (hypertension) by lowering blood pressure.
Medications containing aliskiren include Amturnide (aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide); Tekturna (aliskiren hemifumarate); Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide); Tekamlo (aliskiren hemifumarate and amlodipine besylate); and Valturna (aliskiren hemifumarate and valsartan). Valturna will no longer be marketed after July 2012.
Concomitant use of aliskiren with ARBs or ACEIs in patients with diabetes is contraindicated because of the risk of renal impairment, hypotension, and hyperkalemia. Avoid use of aliskiren with ARBs or ACEIs in patients with renal impairment where GFR < 60 mL/min. Patients should not stop taking aliskiren without talking to your healthcare professional. Stopping aliskiren suddenly can cause problems if high blood pressure (hypertension) is not treated.
See the FDA Warning