PRAC News – May 2014
09.05.2014
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) started two new safety reviews at its May meeting.
Ongoing review of Rienso
In the context of a regular benefit-risk assessment of the medicine (known as a periodic safety update report or PSUR), the PRAC is reviewing new post-marketing data for Rienso (ferumoxytol) including global reports of serious anaphylactic reactions with the medicine. Rienso is used to treat anaemia in patients with long-term kidney disease.
While the review is on-going, the attention of healthcare professionals is being drawn to the existing risk minimisation measures and warning for anaphylactic reactions included in the medicine’s summary of product characteristics and package leaflet.
Review of hydroxyzine-containing medicines started
The PRAC started a review of hydroxyzine-containing medicines, which have been approved in most European Union countries for a variety of uses including for treating pruritus (itching) and anxiety disorders, as premedication before surgery and for sleep disorders.
This review was initiated over concerns about the effects of these medicines on the heart.
Review of Corlentor/Procoralan started
The PRAC has started a review of the medicine Corlentor/Procoralan (ivabradine), which is used to treat the symptoms of adults with long-term stable angina (chest pain due to obstruction in the arteries in the heart) or long-term heart failure (when the heart cannot pump enough blood to the rest of the body).
Signal analysis leads to start of the safety review
The initiation of the safety review of Corlentor/Procoralan is based on initial analysis of a safety signal. This signal originated from the preliminary results of the SIGNIFY study, which showed a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with the medicine in certain patients with symptomatic angina.
A safety signal is information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. Potential signals are mainly identified through EudraVigilance, the European web-based information system designed to manage information on safety reports.
The management of safety signals emerging with medicines is one of the key activities of the PRAC. The PRAC is responsible for the initial analysis, prioritisation and assessment of validated signals, resulting in a PRAC recommendation that can cover any recommendation with a valid marketing authorisation in the EU.
In 2013, the PRAC prioritised and assessed 100 signals, including 43 detected and validated by the EMA and 57 by EU Member States.
Once adopted, the PRAC’s recommendation for regulatory action are then submitted either to the Committee for Medicinal Products for Human Use (CHMP) if the signal concerns a centrally authorised medicine, for endorsement, or to the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) if the signal concerns a nationally authorised medicine.
An overview of PRAC recommendations on safety signals is then published on the EMA webpages after each month’s CHMP and CMD meetings.
Here you may view more about the PRAC recommendations from May 2014.
