The blood pressure drug Rasilez – sold in the U.S. under the brand name Tekturna – will soon bear new safety warnings on its European label, 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 on Friday that it would comply with a recommendation made by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) that the label include a warning against combining products containing aliskiren, the active ingredient in Rasilez/Tekturna, with heart drugs known as ACE inhibitors or ARBs.
“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 released Friday.
Rasilez/Tekturna was brought to market in 2007, and Novartis had high hopes that the drug would become a blockbuster. It is approved as a treatment for hypertension (high blood pressure) either as monotherapy or in combination with other medications. However, the EMA launched a review of the drug after Novartis announced in December that it had halted a study known as ALTITUDE after an independent review committee noted higher adverse events in patients receiving Rasilz/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).
The ALTITUDE trial was a multinational study involving 8,606 patients from 36 countries evaluating the potential benefits of Rasilez/Tekturna to reduce the risk of cardiovascular and renal events in people with type 2 diabetes and kidney impairment.
As a precautionary measure, Novartis stopped promotion of the drug and combination products containing aliskiren in combination with an ACE inhibitor or ARB in December. According to The Wall Street Journal, 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. On Friday, Novartis said that recommendation remains in effect in countries outside Europe, including the U.S.