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Novartis Announces Tekturna Label Changes, Valturna Withdrawal | cialis online

Novartis Announces Tekturna Label Changes, Valturna Withdrawal

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Novartis just announced label changes to its blockbuster hypertension medication, Tekturna (aliskiren), in the United States, following a U.S. Food & Drug Administration (FDA) review. The company also said it will pull another aliksiren product, Valturna, from the market by July 20, 2012.

The agency review involved preliminary findings from the ALTITUDE study, which was meant to review aliskiren’s effect, including the brand Tekturna, on the possibility of adverse reactions to the cardiovascular system and kidneys in high-risk diabetes patients, explained NewsInferno. More than 8,600 type-2 diabetes patients were enrolled in ALTITUDE and treated with either aliskiren or a placebo, along with their regularly prescribed blood pressure medication—either an angiotensin converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB).

Novartis brought Tekturna to market in 2007, with hopes of blockbuster status. Tekturna is approved for high blood pressure treatment and is used as either a monotherapy (alone) or in combination with other medications, said NewsInferno.

The ALTITUDE trial was ceased this past December following findings by an independent review committee that found higher adverse events in patients receiving aliskiren in addition to standard of care. An increased incidence of serious side effects in the high-risk group was seen after 18-24 months and included nonfatal stroke, kidney complications, hyperkalemia, and hypotension. Novartis also stopped promotion of Tekturna and combination products containing aliskiren that are taken in combination with an ACE inhibitor or ARB.

The new label changes include a contraindication against combined use of aliskiren-based products with ACE inhibitors or ARBs in diabetic patients. The FDA also requested inclusion of a warning against the use of aliskiren-based products in patients with moderate renal (kidney) impairment (eGFR < 60 ml/min) taking an ACE inhibitor or an ARB. Aliskiren-based products will continue to be available in the U.S. for the treatment of high blood pressure in appropriate patients. GFR—Glomerular Filtration Rate—is a marker of kidney functioning, explained NewsInferno.

Novartis, after consulting with the FDA, is also stopping its promotion in the U.S. of Valturna (aliskiren and valsartan, USP), a single pill combination of aliskiren and the ARB valsartan. Novartis is also withdrawing marketing authorization of the same combination pill in Switzerland, known there as RasivalR (aliskiren and valsartan), which received marketing approval for export but was not launched.

Possible Tekturna side effects include nonfatal strokes; heart attacks; acute kidney failure and other kidney complications; hyperkalemia, a condition caused by abnormally high levels of potassium in the blood; hypotension, which is abnormally low blood pressure; and syncope, which is a loss of consciousness.

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