Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-8 July 2016

News 08/07/2016

At its July meeting, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) concluded a safety referral on one medicine, and initiated three new safety referrals. It also discussed two ongoing reviews, extended the scope of an ongoing review, and tested its process and procedures for public hearings in the context of an internal test exercise.

PRAC concludes review of Zydelig and issues updated recommendations for use

The PRAC completed its review of Zydelig (idelalisib), confirming that the medicine's benefits outweigh its risks in the treatment of two types of blood cancers, chronic lymphocytic leukaemia and follicular lymphoma. The PRAC however confirmed that there is a risk of serious infections with Zydelig, including Pneumocystis jirovecii pneumonia. It updated the recommendations on managing the risk of serious infections that were issued at the beginning of the review.

More information is provided in the table below.

Review of modified-release paracetamol started

The PRAC initiated a review of the benefits and risks of paracetamol modified- and prolonged-release tablets, which are available in several EU Member States and are designed to release paracetamol over a prolonged period of time. They are different from the usual immediate-release tablets of paracetamol (which release their active substance more quickly and are not included in this review).

The standard procedures for assessing and managing overdose and poisoning with paracetamol are designed for the immediate-release products. The PRAC will evaluate available evidence to determine the risk from overdose with modified- and prolonged-release paracetamol, and whether any additional measures need to be taken.

More information is provided in the table below.

Review of retinoid medicines initiated

The PRAC started a review of retinoid medicines to evaluate measures currently in place for pregnancy prevention and for minimising the possible risk of neuropsychiatric disorders.

Retinoids (which include the active substances acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tazarotene and tretinoin) are taken by mouth or applied as creams or gels to treat several conditions mainly affecting the skin, including acne and psoriasis. Some retinoids are also used to treat certain forms of cancer.

More information is available in the table below.

Review of factor VIII medicines begins

The PRAC started a review of medicines containing factor VIII to evaluate the risk of developing inhibitor proteins in patients starting treatment for haemophilia A. This follows the recent publication of a study whose authors suggested that inhibitors develop more frequently in patients receiving factor VIII medicines made by DNA recombinant technology than in those receiving factor VIII medicines derived from blood.

More information is available in the table below.

Extension of the scope of a safety review

The PRAC extended the scope of a review, which initially only covered canagliflozin, to include the other diabetes medicines in the same class, dapagliflozin and empagliflozin.

The Committee had initiated the review of canagliflozin in April 2016 after an increase in amputations mostly affecting toes was observed in an ongoing clinical trial called CANVAS. The scope of this referral was extended because the potential risk being evaluated for canagliflozin may be relevant for the other medicines in this class (SGLT2 inhibitors).

Please see the table below for more information.

Practice run on public hearings

EMA conducted an internal practice exercise (dry run) in order to test the process and procedures for public hearings. Using a fictional scenario of a safety review, the PRAC experienced how such a hearing would take place. This has enabled EMA to ensure all practical arrangements needed for these hearings are in place and PRAC members to test this new form of interaction. Following this successful simulation, the PRAC is ready to incorporate public hearings as part of its core activities.

Public hearings are a new tool for EMA to engage European Union (EU) citizens in the regulation of medicines and to listen to their views and experiences. The pharmacovigilance legislation has given the PRAC the possibility to hold public hearings as part of certain safety reviews of medicines. Contributions made by the public during these hearings will be considered by the PRAC and inform the Committee's decision-making.

Public hearings will be held on a case-by-case basis, where the Committee determines that collecting the views of the public would bring added value to its review. The first public hearing could take place as early as the fourth quarter of 2016, as soon as a relevant topic is identified.

More information is available on our 'public hearings' webpage as well as in the for these hearings.


PDF icon Agenda - PRAC draft agenda of meeting 4-8 July 2016

Start of referrals

Factor VIII

Article 31-referral: Factor VIII

PDF icon Review started

PDF icon PRAC list of questions

PDF icon Timetable for the procedure

PDF icon Annex I

PDF icon Referral notification

Paracetamol-modified release

Article 31-referral: Paracetamol-modified release

PDF icon Review started

PDF icon PRAC list of questions

PDF icon Timetable for the procedure

PDF icon Annex I

PDF icon Referral notification

Retinoid-containing medicinal products

Article 31-referral: Retinoid-containing medicinal products

PDF icon Review started

PDF icon PRAC list of questions

PDF icon Timetable for the procedure

PDF icon Annex I

PDF icon Referral notification

Recommendation by PRAC


Article 20-procedure: Zydelig

PDF icon Summary of PRAC recommendation

Extension of scope

SGLT2 inhibitors (previously Canagliflozin)

Article-20 procedure: SGLT2 inhibitors (previously Canagliflozin)

PDF icon Amended review started

PDF icon Updated PRAC list of questions

PDF icon Amended timetable for the procedure

PDF icon Amended referral notification

Ongoing referrals

Article-20 referral: Direct-acting antivirals for treatment of hepatitis C (interferon-free)Under evaluationThe PRAC adopted a list of outstanding issues to be addressed by the marketing-authorisation holders.
Article-31 referral: Gadolinium-containing contrast agentsUnder evaluationThe PRAC adopted a list of experts for an ad-hoc expert group meeting.

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