SAFETY ALERT: New Warning and Contraindication for Aliskiren

The FDA has notified healthcare professionals 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 renal impairment.

Concomitant use of aliskiren with ARBs or ACEIs in patients with diabetes is now contraindicated because of the risk of renal impairment, hypotension, and hyperkalemia. Also, the use of aliskiren with ARBs or ACEIs in patients with renal impairment where GFR <60mL/min should be avoided. The updated safety labels for aliskiren-containing medications are based on preliminary data from a clinical trial, “Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE).”

Aliskiren-containing medications include Novartis's Amturnide (aliskiren hemifumarate/amlodipine besylate/hydrochlorothiazide), Tekturna (aliskiren hemifumarate), Tekturna HCT (aliskiren hemifumarate/hydrochlorothiazide), Tekamlo (aliskiren hemifumarate/amlodipine besylate), and Valturna (aliskiren hemifumarate/valsartan). Valturna will no longer be marketed after July 2012.

Aliskiren is a renin inhibitor used to treat hypertension by lowering blood pressure.

For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm301120.htm.