The European Medicines Agency has completed a benefit-risk review of intravenous (given into a vein) nicardipine medicines.
The Agency’s Committee on Medicinal Products for Human Use (CHMP) concluded that these medicines should only be used to treat acute (sudden) life-threatening high blood pressure and to control high blood pressure after an operation. Use of intravenous nicardipine medicines in other indications is no longer recommended.
The CHMP also recommended that these medicines should only be given by continuous infusion (drip) into a vein by a specialist in a hospital or intensive care unit.
Detailed information on the recommended uses of intravenous nicardipine, including instructions on how to use these medicines, can be found below.
The review of intravenous nicardipine was triggered by the UK medicines regulatory agency (MHRA), following submission in the UK of an application for a generic intravenous nicardipine medicine. The MHRA was concerned that the clinical data submitted were inadequate to determine the benefits and risks of the generic medicine in the proposed indications. It also noted that medicines containing nicardipine given intravenously had been authorised in other EU countries but that the authorised uses differed between countries. The MHRA therefore decided to request an EU-wide review of these medicines.
Having assessed the available evidence on the safety and effectiveness of intravenous nicardipine from published studies and post-marketing data, the CHMP concluded that an intravenous formulation of nicardipine is a useful treatment for high blood pressure in specific settings and with appropriate specialist intervention and monitoring.
The CHMP opinion will now be sent to the European Commission for the adoption of a final legally binding decision throughout the EU.