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FDA advices not to prescribe Aliskiren drug (Tekturna, Novartis Pharmaceuticals) in combination with ACE inhibitors and angiotensin-receptor blockers for diabetics

The US Food and Drug Administration announced that antihypertensive drugs containing aliskiren (Tekturna, Novartis Pharmaceuticals) in combination with ACE inhibitors and angiotensin-receptor blockers (ARBs) must not be prescribed by Physicians for patients with diabetes, as the agency reported diabetes patients on these combinations are at risk of renal impairment, hypotension, and hyperkalemia. The FDA also recommends in patients with moderate to severe renal impairment, that such drug combinations should be avoided by clinicians.

These recommendations leading to the label changes were based on preliminary data from a Novartis’ Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE) trial that evaluated aliskiren in combination with ACE inhibitors and ARBs. Novartis had to halt the trial in December 2011 due to a higher risk of renal impairment, hypotension, and hyperkalemia along with an apparent lack of efficacy.

The FDA also said that, “Although the preliminary ALTITUDE data demonstrated that aliskiren drug when prescribed along with the other cardiac drugs could achieve a "slight excess" in reducing cardiovascular adverse events such as stroke/ death, this did not lead to deriving a concrete conclusion about the causal association between these drugs and the cardiovascular adverse events. The final trial results as well as those from other aliskiren studies are in the pipeline for evaluation by the agency.

Valturna (Novartis Pharmaceuticals), which combines aliskiren and the ARB valsartan, was dramatically affected by the FDA's announcement. In the backdrop of this recommendation, Novartis will cease marketing of Valturna post July 20 this year, 2012 so as "to enable physicians to transition patients to alternate therapies" till then.

Apart from Tekturna and Valturna, the FDA announcement was applied to other aliskiren-containing medications from the same company such as:

  • Tekturna HCT, combination of aliskiren and diuretic hydrochlorothiazide.
  • Tekamlo, combination of aliskiren and the calcium-channel blocker amlodipine.
  • Amturnide, combination of aliskiren, amlodipine and hydrochlorothiazide.
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