Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 June 2017

News 09/06/2017

PRAC starts new referral; agrees date of its first public hearing; concludes review of docetaxel

PRAC reviews multiple sclerosis medicine Zinbryta

At its June meeting, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) started a review of the medicine Zinbryta (daclizumab) used to treat adults with relapsing forms of multiple sclerosis. The review follows the death from fulminant liver failure of a patient who was treated with Zinbryta in an ongoing observational study, as well as four cases of serious liver injury.

The PRAC will now evaluate all available data and determine whether there are any implications for the use of the product and if there is a need to introduce any new measures to minimise the risk of liver damage.

More information is available below.

PRAC concludes there is no evidence of a change in the known risk of neutropenic enterocolitis cases with docetaxel

The PRAC has concluded that there is no evidence of a change in the known risk of neutropenic enterocolitis in the European Union (EU) after treatment with docetaxel, a cancer medicine.

Neutropenic enterocolitis is a serious inflammatory condition of the intestine which is known to occur in up to 1 in 1,000 cancer patients taking the medicine.

Having considered available data on docetaxel, the Committee concluded that the recent rise in reporting of the condition observed in France could be due to increased awareness among healthcare professionals. Reporting rates in the EU as a whole do not provide any evidence of an increase in the incidence of neutropenic enterocolitis.

More information is available below.

PRAC sets date for public hearing on use of valproate-containing medicines

The PRAC decided it will hold its very first public hearing on 26 September 2017 at the Agency's premises in London, in the context of the safety review of the use of valproate-containing medicines in the treatment of women and girls who are pregnant or of childbearing age. EU citizens will be invited to share their experiences with these medicines so that this can be taken into account in the Committee's recommendation. Valproate-containing medicines are approved nationally in the EU to treat epilepsy, bipolar disorder and in some countries, migraine.

Further information, including a list of specific questions on which information from the public is sought, a summary of the safety concerns, as well as practical information on how to participate and an application form will be published at the beginning of July.

This is the first time the PRAC will hold a public hearing during a safety review of a medicine. It follows the adoption of and a simulation training in 2016. Public hearings will give EU citizens a voice in the evaluation of the safety of medicines and empower them to express their views on issues related to the safety of certain medicines and the management of risks. Their views will bring a unique new dimension to the assessment of medicines by the PRAC for the benefit of public health.


PDF icon Agenda - PRAC draft agenda of meeting 6-9 June 2017

Start of referral

Zinbryta (daclizumab)

Article-20 referral: Zinbryta (daclizumab)

PDF icon Review started

PDF icon PRAC list of questions

PDF icon Timetable for the procedure

PDF icon Referral notification

Safety signal evaluation

Signal evaluation concluded

Ongoing referrals

Article-31 referral: Valproate and related substancesUnder evaluationPRAC continued its assessment and decided to organise a public hearing on 26 September 2017.
Article-31 referral: Gadolinium-containing contrast agentsPRAC recommendation issued in March 2017PRAC continued its re-examination
Article-31 referral: Factor VIIIPRAC recommendation issued in May 2017Following the PRAC's May 2017 recommendation, a marketing authorisation holder involved with this referral procedure has requested a re-examination. Upon receipt of the grounds for their request, the PRAC will start a re-examination, which is expected to conclude at the PRAC meeting of 29 August–1 September 2017.
Article-31 referral: Paracetamol-modified releaseUnder evaluationPRAC continued its assessment
Article-31 referral: Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactionsUnder evaluationPRAC continued its assessment
Article-31 referral: Retinoid-containing medicinal productsUnder evaluationPRAC continued its assessment
Article-31 referral: Systemic and inhaled quinolone and fluoroquinolone antibioticsUnder evaluationPRAC continued its assessment

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