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U.K. Regulator Issues Aliskiren (Rasilez and Tekturna) Update

Mar 9, 2012 | Parker Waichman LLP

U.K.'s health regulator has issued a Drug Safety Update detailing new contraindications for diabetics and kidney patients using the blood pressure drug, aliskiren (marketed as Rasilez and Tekturna).  According to the Medicine and Healthcare Products Regulatory Agency (MHRA), the use of aliskiren in combination ACE inhibitors and Angiotensin II receptor blockers (ARB) is now contraindicated in these patients.

The MHRA also stated that the combination of aliskiren with an ACE inhibitor or ARB is not recommended in any other patients. Any use of aliskiren (either as monotherapy or in combination with other medicines) is no longer recommended in any patient with severe kidney impairment.

Possible side effects of aliskiren include:

  • Strokes (a/k/a cerebrovascular accident (CVA) - rapid loss of brain function(s) due to disturbance in the blood supply to the brain i.e. bleed) Heart attacks Acute rental failure and other rental complications (renal = kidney)
  • Hyperkalemia (kidneys not functioning adequately)
  • Hypotension (abnormally low blood pressure)
  • Syncope (loss of consciousness)

Aliskiren was brought to market as Rasilez in Europe, and Tekturna in the U.S. by Novartis in 2007. It is approved as a treatment for hypertension (high blood pressure) either as monotherapy or in combination with other medications.  Regulators in Europe began a review of aliskiren late last year, after Novartis announced it was shutting down its ALTITUDE study, which was designed to evaluate the effect of aliskiren on the likelihood of cardiovascular and kidney events in high-risk diabetic patients.

The ALTITUDE study was halted after an independent review committee noted higher adverse events in patients receiving Rasilez/Tekturna in addition to standard of care in the trial. There was also an increased incidence after 18-24 months of serious side effects in the high risk population, including non-fatal stroke, kidney complications, hyperkalemia (high potassium), and hypotension (low blood pressure). 

In January, Novartis agreed to a request from European regulators to add new safety warnings to the labels of aliskiren products to reflect the findings of the ALTITUDE trial. Novartis also wrote to physicians world-wide recommending that patients with Type 2 diabetes shouldn’t be treated with aliskiren, or combination products containing aliskiren, if they are also receiving an ACE inhibitor or ARB.

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