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FDA Drug Safety: New Warning for Blood Pressure Medicines

The United States Food and Drug Administration released a safety announcement stating possible risks associated with using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney impairment.

The combination of these drugs should be avoided in patients with diabetes. The FDA is adding a new warning stating that patients with kidney impairment should avoid the use of these drug combinations as well, according to preliminary data from the clinical trial, “Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE).”

Aliskiren is a renin inhibitor used to treat high blood pressure (hypertension) by lowering blood pressure.

Aliskiren is found in the following medications:

  • Amturnide (aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide)
  • Tekturna (aliskiren hemifumarate)
  • Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide)
  • Tekamlo (aliskiren hemifumarate and amlodipine besylate)
  • Valturna (aliskiren hemifumarate and valsartan)*

 

The FDA advises patients of the following:

  • 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).
  • 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.
  • Report any side effects you experience to the FDA MedWatch program using the information in the “Contact FDA” box at the bottom of the page.

For more information regarding the new warning and contraindiction for blood pressure medicines containing aliskiren, visit the FDA website.

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