Novartis to update high blood pressure drug label
Novartis has planned to update the Rasilez's labelling to include contraindications against combined use with a number of products.
The company will follow the advice of the EMA's Committee for Medicinal Products for Human Use (CHMP) in making changes to the product information details for its high blood pressure therapy.
According to the CHMP, Rasilez and other products containing aliskiren should not be used alongside ACE inhibitors or ARBs in patients with diabetes and/or moderate to severe renal impairment, due to safety concerns.
Novartis Pharmaceuticals division head David Epstein said they are working closely with the CHMP, EMA and other health authorities worldwide to continue to provide Rasilez and combination products containing aliskiren.