PRAC News – November 2014


On its November 2014 meeting the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) endorsed recommendations regarding the safe use of Corlentor/Procoralan (ivabradine), Kogenate Bayer/Helixate Nexgen and Tecfidera.

PRAC recommends measures to reduce risk of heart problems with Corlentor/Procoralan (ivabradine)

Th 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 is used to treat symptoms of angina (chest pain due to problems with the blood flow to the heart) and to treat heart failure.

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 recommendations regarding use with other medicines. Because patients treated with Corlentor/Procoralan are at an increased risk of developing atrial fibrillation (a heart condition that causes an irregular and often abnormally fast heart rate), 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).

These recommendations follow a review of the final data from the SIGNIFY study, which evaluated whether treatment with Corlentor/Procoralan in patients with coronary heart disease (heart disease caused by the obstruction of the blood vessels that supply the heart muscle) without heart failure reduces the rate of events such as heart attacks when compared with placebo. The study showed that in a subgroup of patients who had symptomatic angina there was a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with Corlentor/Procoralan compared with placebo. The data also indicated a higher risk of bradycardia with Corlentor/Procoralan compared with placebo.

Here you may read more about PRAC recommendations related to heart adverse reactions in patients treated with ivabradine.

PRAC recommends further assessment of risk of developing inhibitors with Kogenate Bayer/Helixate NexGen

The PRAC has looked at new evidence from two recently published studies suggesting that previously untreated haemophilia patients may be at greater risk of developing inhibitors (antibodies) if treated with the factor VIII medicine Kogenate Bayer/Helixate NexGen than if treated with other products that contain factor VIII (the blood clotting factor needed by haemophilia patients).

The development of inhibitors is a known risk with products that contain factor VIII. In 2013 the PRAC reviewed the evidence available at the time about the development of inhibitors in these patients and found that it did not support an increased risk in those treated with Kogenate Bayer/Helixate NexGen. In the light of the new data, the PRAC is recommending a further in-depth examination of the available evidence.

PRAC advises informing about first case of PML in a patient treated with Tecfidera

The PRAC has discussed a fatal case of progressive multifocal leukoencephalopathy (PML) which was reported in a patient treated with Tecfidera (dimethyl fumarate), a medicine used for relapsing-remitting multiple sclerosis. This is the first case of PML, a rare viral brain infection with symptoms that can be similar to those of a multiple sclerosis attack, to be reported in association with Tecfidera.

The fatal case of PML occurred after long-term treatment with the medicine in a patient experiencing severe long-term lymphopenia, a known possible side effect of Tecfidera.

The PRAC recommended that healthcare professionals and patients be informed and considered that there should be further evaluation of this case

Here you may read more about PRAC recommendations from November 2014.