FDA announces new warning and contraindication for aliskiren

The FDA is warning clinicians not to combine the BP medication aliskiren (Tekturna) with ACE inhibitors and angiotensin receptor blockers (ARBS) in patients with diabetes or renal impairment.

The warning comes after the "Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE)," was discontinued after researchers found an increased risk for adverse events in high-risk patients taking the direct renin inhibitor as an add-on to other anti-hypertensive medications.

Patients with diabetes who take the drugs concomitantly are at increased risk for renal impairment, hypotension and hyperkalemia. The agency also warned that clinicians should avoid prescribing aliskiren in patients with severe renal impairment (glomerular filtration rate <60 mL/min).

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.


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