Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 May 2014

News 08/05/2014

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) started two new safety reviews at its May meeting. The PRAC also provided an update to an ongoing review of a medicine.

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 warnings for anaphylactic reactions included in Rienso's product information.

Review of hydroxyzine-containing medicines started

The PRAC started a review of hydroxyzine-containing medicines, which have been approved in most European Union (EU) 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). Corlentor/Procoralan 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. The PRAC considered that thorough analysis of the data was necessary through a safety review.

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, but may also come through the scientific literature or communications received from other regulatory authorities worldwide.

The management of safety signals emerging with medicines is one of the key activities of the PRAC. The Committee is responsible for the initial analysis, prioritisation and assessment of validated signals, resulting in a PRAC recommendation. These recommendations can cover any medicine with a valid marketing authorisation in the EU, including nationally and centrally authorised medicines.

In 2013, the PRAC prioritised and assessed 100 signals, including 43 detected and validated by the EMA and 57 by European Union (EU) Member States. More information is available in the EMA's 2013 annual report as well as the 2013 annual report on EudraVigilance.

Once adopted, the PRAC's recommendations 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, for information.

An overview of PRAC recommendations on safety signals is then published after each month's CHMP and CMDh meetings, meaning approximately three weeks after the PRAC meeting during which the safety signals were discussed.


PDF icon Agenda - PRAC draft agenda of meeting 5-8 May 2014

Start of referral procedures


Article-31 referral: Hydroxyzine

PDF icon Review started
PDF icon Referral notification
PDF icon PRAC list of questions
PDF icon Timetable for the procedure
PDF icon Annex I

Corlentor and Procoralan

Article-20 procedure: Corlentor and Procoralan

PDF icon Review started
PDF icon Referral notification

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