Novartis blood pressure drug Rasilez – sold in the U.S. under the brand name Tekturna – will get new safety warnings in Europe at regulators’ request, after a clinical trial was halted because subject patients experienced a high rate of strokes and kidney problems.
According to a report from Bloomberg News, Novartis, the maker of Rasilez/Tekturna announced that it would comply with a recommendation made by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The Swiss drugmaker will revise the drug’s European label to say that Rasilez should not be used in patients with diabetes or kidney problems who are also using ACE inhibitors or angiotensin receptor blockers. Like Rasilez, ACE inhibitors and ARBs are used to treat high blood pressure.
“This decision comes after extensive interactions between Novartis and the CHMP. Patient safety continues to be the highest priority for Novartis, and we are working closely with the CHMP, EMA and other health authorities worldwide to continue to provide Rasilez and combination products containing aliskiren to the most appropriate patient population who would benefit,” David Epstein, Division Head of Novartis Pharmaceuticals, said in a statement.
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