EMA PRAC’s recommendations to reduce risk of heart problems with ivabradine

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of Corlentor/Procoralan (ivabradine) and has made recommendations aimed at reducing the risk of heart problems, including heart attack and bradycardia (excessively low heart rate), in patients taking the medicine.

Corlentor/Procoralan was developed by independent French drugmaker Servier and is approved to treat symptoms of angina and to treat heart failure. Last year, commercial rights to the drug were licensed to US biotech firm Amgen (Nasdaq: AMGN for the US market (The Pharma Letter July 10, 2013).

The PRAC made recommendations about the resting heart rate of patients before starting treatment or when the dose is adjusted, recommendations on when treatment should be stopped and regarding use with other medicines. Because patients treated with Corlentor/Procoralan are at an increased risk of developing atrial fibrillation, the PRAC recommended monitoring for this condition in patients treated with Corlentor/Procoralan. In addition, the PRAC recommended that, when used for angina, Corlentor/Procoralan should only be used to alleviate symptoms as the available data do not indicate that the medicine provides benefits on outcomes such as reducing heart attack or cardiovascular death (death due to heart problems).