FDA Drug Safety Communication: Tekturna

Blood pressure medicines containing aliskiren

/ Author:  / Reviewed by: Joseph V. Madia, MD

The U.S. Food and Drug Administration (FDA) is warning of possible risks when using blood pressure medicines containing aliskiren" data-scaytid="1">aliskiren with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment.

These drug combinations should not be used (are contraindicated) in patients with diabetes. In addition, a new warning is being added to avoid use of these drug combinations in patients with kidney impairment.

The labels for the aliskiren drugs are being updated based on preliminary data from a clinical trial, “Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE).”

Facts about aliskiren-containing products

  • Aliskiren is a renin inhibitor used to treat high blood pressure (hypertension) by lowering blood pressure.
  • Aliskiren is found in the following medications:

    • Amturnide" data-scaytid="23">Amturnide (aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide)
    • Tekturna (aliskiren hemifumarate)
    • Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide)
    • Tekamlo" data-scaytid="53">Tekamlo (aliskiren hemifumarate and amlodipine besylate)
    • Valturna" data-scaytid="61">Valturna (aliskiren hemifumarate and valsartan" data-scaytid="63">valsartan)*
  • In 2011, a total of approximately 2.4 million prescriptions for aliskiren-containing products were dispensed to 451,000 patients from U.S. outpatient retail pharmacies.1
  • *Novartis (the manufacturer of aliskiren-containing products) decided to stop marketing Valturna, a combination drug product containing aliskiren and the ARB drug valsartan, but will ensure that Valturna is available until July 2012 so that heathcare professionals can transition patients to other therapy.

In ALTITUDE, the risks of kidney (renal) impairment, low blood pressure (hypotension), and high potassium blood levels (hyperkalemia) in a group of patients taking aliskiren plus an ARB or ACEI increased relative to a group of patients taking placebo plus an ARB or ACEI.

The preliminary data from ALTITUDE also demonstrated a slight excess of cardiovascular events (death or stroke) in the aliskiren group [see Data Summary]; however, FDA has reached no definite conclusion regarding an actual link between these drugs and death or stroke. FDA will evaluate the final trial results as well as results from other aliskiren trials and will communicate any new information when it becomes available.

The following recommendations are being added to the drug labels for aliskiren-containing products as of 4/20/12:

  • A new contraindication against the use of aliskiren with ARBs or ACEIs in patients with diabetes because of the risk of renal impairment, hypotension, and hyperkalemia.
  • A warning to avoid use of aliskiren with ARBs or ACEIs in patients with moderate to severe renal impairment (i.e., where glomerular filtration rate [GFR] < 60 mL/min). 

Additional Information for Patients

  • Do not stop taking aliskiren without talking to your healthcare professional. Stopping aliskiren suddenly can cause problems if your high blood pressure (hypertension) is not treated.
  • Tell your healthcare professional if you are taking an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin receptor blocker (ARB). (See Tables 2 and 3)
  • Tell your healthcare professional if you have been diagnosed with diabetes or kidney problems.
  • Discuss any questions you have about aliskiren with your healthcare professional.

Additional Information for Healthcare Professionals

  • Concomitant use of aliskiren with ARBs or ACEIs in patients with diabetes is contraindicated because of the risk of renal impairment, hypotension, and hyperkalemia.
  • Avoid use of aliskiren with ARBs or ACEIs in patients with renal impairment where GFR < 60 mL/min.
  • Valturna (a combination drug containing aliskiren and valsartan) should not be used in patients with diabetes.
  • Valturna will no longer be marketed after July 2012. See Novartis’s website for more information.
  • Be aware of the preliminary findings from the ALTITUDE trial for death and stroke; FDA has not concluded that there is a link between these drugs and death or stroke.
Review Date: 
April 20, 2012