Novartis agrees to pull Valturna® from market and adds warning labels on drugs containing aliskiren

American Heart Association Comment

April 20, 2012 Categories: Advisories & Comments, Heart News, Stroke News
DALLAS – April 20, 2012 ― Novartis has announced it will pull its combination product Valturna® (which contains aliskiren and valsartan) from U.S. markets.  Aliskiren (Tekturna®), one of the components of Valturna, will remain on the market for appropriate high blood pressure patients after the conclusion of a Federal Drug Administration (FDA) assessment of the drug. 
 
But it and all the remaining combinations of aliskiren and other agents will now be contraindicated for use in patients with diabetes who are also taking an ACE inhibitor or ARB.  They may still be used in patients without diabetes, but in those will carry a warning for use in patients with moderate to severe renal impairment.
 
In December 2011, Novartis, the maker of  Tekturna, stopped the international Phase III ALTITUDE study, investigating the drug aliskiren (Tekturna) in high risk patients with type 2 diabetes and decreased kidney function, when cumulative data showed an increased risk of high potassium levels, worsening kidney function and non-fatal stroke. 
 
In an interim review of the placebo-controlled ALTITUDE study,  an independent data review board found that patients were unlikely to benefit from treatment with aliskiren when given in addition to “optimal cardiovascular treatment” including an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).   The review also found an increased incidence of non-fatal stroke, renal complications, hyperkalemia and hypotension when these medications were combined.
 
Aliskiren was approved in 2007 for use in Europe (under the brand name Rasilez) and in the U.S. as a single use treatment option or as a combination treatment option for hypertension. While most of the combinations include aliskiren and other blood pressure medications, such as a diuretic or fluid pill, or a calcium channel blocker, one of the previously approved combinations, Valturna®, includes aliskiren and valsartan, an ARB or angiotensin receptor blocker.
 
Thursday, Novartis announced that after discussion with the FDA, it has updated aliskiren labels in the U.S., warning against combined use of any of its aliskiren-based products with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) in patients with diabetes. 
 
In addition, the FDA said healthcare professionals should avoid use of aliskiren with ARBs or ACEIs in patients with moderate to severe renal impairment.
 
  “Aliskiren-based products will continue to be available in the US for the treatment of high blood pressure in appropriate patients,” but after consultation with the FDA, Novartis says it will “voluntarily cease marketing in the U.S. of Valturna® and withdraw the combination product from the U.S. market as of July 20, 2012.
  
The American Heart Association recommends that diabetic patients taking Valturna should consult with their healthcare provider immediately to determine what they should substitute for Valturna.   
 
Patients with diabetes taking any aliskiren-containing drug along with an ACEi (angiotensin converting enzyme inhibitor) or with an ARB (angiotensin receptor blocker) should likewise consult to see how their medications should be changed.  Patients with any degree of renal insufficiency, or who may be uncertain if they have this condition, should also consult with their healthcare provider.
 
If you are uncertain whether or not you are taking an ACE inhibitor or an ARB, click these links on the American Heart Association website – ACE inhibitors and ARBs
 
Additional resources:
 
 
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