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Novartis Agrees to New Rasilez Warnings

Feb 20, 2012 | Parker Waichman LLP

Following the halt of the ALTITUDE trial, Novartis has agreed to comply with a request by European regulators change the label for its blood pressure drug, Rasilez, to include a contraindication against combined use of aliskiren with an ACE inhibitor or an ARB in patients with diabetes and/or patients with moderate to severe renal impairment.   Novartis sells Rasilez in the U.S. under the brand name Tekturna.

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP)  began reviewing Rasilez following the Novartis decision to halt the ALTITUDE study in December.  The decision was mad after the clinical trial’s Data Monitoring Committee reviewed preliminary interim analyses and concluded that study patients were unlikely to benefit from aliskiren and there was a higher incidence of adverse events related to non-fatal stroke, renal complications, hyperkalaemia and hypotension in this high-risk population.

According to Novartis, doctors in Europe will now be advised that patients who have diabetes and/or moderate to severe renal impairment, who are also taking Rasilez and an ACE inhibitor or an ARB, should receive alternate treatment under a physician's supervision. In other patients taking Rasilez or combination products containing aliskiren - the active ingredient in Rasilez - in combination with an ACE inhibitor or an ARB, the balance of benefits and risks of continuing treatment should be considered carefully.

In December, Novartis wrote to physicians worldwide recommending that patients with type 2 diabetes should not be treated with aliskiren, or combination products containing aliskiren, if they are also receiving an ACE inhibitor or ARB.  In Friday's announcement, the company said that recommendation remains in effect for countries outside Europe.

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