FDA says Aliskiren medicines & ACE inhibitors or Angiotensin Receptor Blockers risky in some kidney problems or diabetes
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The FDA has released a new drug safety communication and contraindication alert. What they have done is to warn healthcare professionals about possible risks IF aliskiren-containing medications are combined with certain other medicines in the Angiotensin converting enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) family in patients with diabetes or with kidney (renal) impairment (GFR less than 60 ml/min)-talk to your doctor about this number.

Aliskiren is a medicine used to treat high blood pressure that belongs to the renin inhibitor family and aliskiren containing medicines include:

  1. Amturnide (aliskiren hemifumarate plus amlodipine and hydrochlorothiazide)
  2. Tekturna (aliskiren hemifumarate)
  3. Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide)
  4. Takamlo (aliskiren hemifumarate and amlodipine)
  5.  Valturna (aliskiren hemifumarate and valsartan)-this will no longer be marketed after July 2012.

All of the labels of the aliskiren containing medicines are being updated based on the results from the ALTITUDE study (Aliskiren Trial in Type 2 Diabetes Using Cardio-Ranal Endpoints). The combination of aliskiren with ACE inhibitors (these generally end with the generic name Pril such as captopril, ramipril, quinapril, etc.) or ARBs (these generic names generally end with sartan such as valsartan) in people with diabetes is CONTRAINDICATED (do not combine) because of risk of kidney impairment, low blood pressure (hypotension) and low blood potassium (hypokalemia).

People with kidney impairment (renal impairment) where a measure of kidney function (Glomerular Filtration Rate or GFR) is less than 60 ml per minute should avoid using aliskiren with ARBS or ACEIs.

It is crucial to talk to your doctor BEFORE you make any changes to your medicines. Aliskiren in particular should NEVER be stopped suddenly because this can lead to problems if your high blood pressure is not treated. The FDA Safety communication can be found at www.fda.gov.

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