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

News 10/03/2017

PRAC concludes a safety referral and starts one; decides to hold first public hearing

At its March meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) concluded a safety review and started a new one for which there will be a public hearing. The PRAC also started the review of docetaxel-containing medicines in the context of a safety signal and discussed three ongoing referrals.

PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations

The PRAC has recommended the suspension of the marketing authorisations for four linear gadolinium contrast agents because of evidence that small amounts of the gadolinium they contain are deposited in the brain. Evidence has not shown signs of harm.

The agents concerned are intravenous injections of gadobenic acid, gadodiamide, gadopentetic acid and gadoversetamide, which are given to patients to enhance images from magnetic resonance imaging (MRI) body scans.

Although no symptoms or diseases linked to gadolinium in the brain have been reported, the PRAC took a precautionary approach, noting that data on the long-term effects in the brain are limited.

More information is available below.

New review of valproate use in pregnancy and women of childbearing age

The PRAC has started a new review of the use of valproate-containing medicines in the treatment of women and girls who are pregnant or of childbearing age. These medicines are approved nationally in the European Union (EU) to treat epilepsy, bipolar disorder and in some countries, migraine.

In a previous review in 2014, the European Medicines Agency (EMA) agreed on measures to strengthen warnings and restrictions on valproate use in women and girls, due to the risk of malformations and developmental problems in babies who are exposed to valproate in the womb.

Concerns have since been raised about how effective these measures are. Therefore, the French medicines regulator, ANSM, asked EMA to review the measures and consider whether further EU-wide action should be recommended to minimise the risks in women who are pregnant or of childbearing age.

First public hearing to be organised on valproate

The PRAC has decided to organise a public hearing as part of the review of valproate to listen directly to the experience of EU citizens with these medicines, so this can be taken into account in the Committee's recommendation.

The PRAC is expected to set a date for its first public hearing at its meeting in June, when it has conducted a first round of evaluation of the available scientific evidence. The hearing will be announced prominently on the Agency's website together with a list of specific questions on which information from the public is sought and information on the date, time, location and how to register.

This is the first time the PRAC will hold a public hearing during a safety review of a medicine. It follows the adoption of rules 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.


More about the safety review of valproate is available below.

PRAC investigates cancer medicine docetaxel

The PRAC is investigating the cancer medicine docetaxel following cases of neutropenic enterocolitis in patients in France. Most of the patients were being treated for operable breast cancer.

A preliminary assessment by the PRAC indicates that the frequency of this known side effect has not increased in the last two years. A thorough evaluation of available data is being carried out and final conclusions will be published once the review has been completed.

More information is available below.


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


Start of referrals

Valproate and related substances

Article-31 referral: Valproate and related substances


PDF icon Review started

PDF icon PRAC list of questions

Timetable for the procedure

PDF icon Annex I

PDF icon Referral notification


Recommendation by PRAC

Gadolinium-containing contrast agents

Article-31 referral: Gadolinium-containing contrast agents


PDF icon Summary of PRAC recommendation


Safety signal evaluation

Ongoing signal evaluation


Ongoing referrals

Article-31 referral: Paracetamol-modified releaseUnder evaluationPRAC adopted a list of outstanding issues
Article-31 referral: Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactionsUnder evaluationPRAC adopted a list of outstanding issues
Article-31 referral: Factor VIIIUnder evaluationPRAC adopted a list of outstanding issues
Article-31 referral: Retinoid-containing medicinal productsUnder evaluationOn 3 March 2017, as part of this review, EMA organised a meeting with patients' organisations and healthcare professionals who work in the area of psoriasis, acne and women's health. The participants expressed their views as regards a PRAC list of questions on how to improve awareness, understanding and compliance with retinoids' pregnancy prevention programme. The outcome of the meeting will be reported back to the PRAC in May 2017 to feed into the review and contribute to the PRAC recommendation later in 2017.
Article-31 referral: Systemic and inhaled quinolone and fluoroquinolone antibioticsUnder evaluationPRAC continued its assessment


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