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Novartis Updating Tekturna Label with Warnings for Diabetes, Kidney Patients. Announces Valturna Market Withdrawal.

Apr 20, 2012 | Parker Waichman LLP

Novartis has announced that it will be making changes to the labels for Tekturna and other aliskiren-based medications regarding serious risks posed by such drugs when they are used by diabetics or patients with kidney failure who are also taking ACE Inhibitors or angiotensin receptor blockers (ARBs).  Novartis also said it will pull the drug Valturna, a single pill combination of aliskiren and the ARB valsartan, from the U.S. market by July 20, 2012.

According to a statement from Novartis, the company is taking these actions at the request of the U.S. Food &Drug Administration (FDA), which has completed a preliminary review of its halted ALTITUDE study.  This past December, Novartis announced ALTITUDE had been halted after an independent review committee noted higher adverse events in patients receiving aliskiren in addition to either an ARB or ACE inhibitor.  There was also an increased incidence after 18-24 months of serious side effects in the high risk population, including non-fatal stroke, kidney complications, hyperkalemia, and hypotension.

The modified Tekturna labels will warn against:

  • The combined use of aliskiren-based products with ACE Inhibitors and angiotensin receptor blockers (ARBs) in patients with diabetes. 
  • A warning against the use of aliskiren-based products in patients with moderate renal (kidney) impairment (eGFR < 60 ml/min) who are also taking an ACE inhibitor or an ARB. 

In addition to Tekturna, the new warnings will be added to:

  • Tekturna HCT (aliskiren and hydrochlorothiazide)
  • Tekamlo(TM) (aliskiren and amlodipine)
  • Amturnide(TM) (aliskiren, amlodipine and hydrochlorothiazide)

Patients who take Valturna are being advised to discuss alternative treatments with their doctors before July 20, 2012.

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