FDA is warning of possible risks for people with diabetes or kidney disease who use blood pressure medicines containing aliskiren in combination with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs). ACEIs and ARBs relax blood vessels by blocking the effects of a hormone that causes vessels to narrow.
These drug combinations should not be used in people with diabetes or with moderate to severe kidney disease. The labels for the aliskiren drugs below are being updated based on early data from a clinical trial, Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE).
- 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). Valturna will not be sold after July 2012.
Risk: People with diabetes who take aliskiren with ARBs or ACEIs are at risk for kidney disease, low blood pressure and higher-than-normal potassium levels. People who already have kidney disease should also avoid aliskiren.
- Do not stop taking aliskiren without talking to your health care professional. Stopping the drug suddenly can cause problems if your high blood pressure is not treated.
- Tell your health care professional if you are taking an ACEI or an ARB. (See a list of ACEI and ARB products in Tables 2 and 3.)
- Tell your health care professional if you have been diagnosed with diabetes or kidney problems.