Meeting highlights from the PRAC meeting in March 2017


At its March 2017 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 magnetic resonance imaging (MRI) 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 on HALMED's website.

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 member states of the European Union (EU). Valproate has been authorised in the Republic of Croatia in the treatment of epilepsy and bipolar disorder.

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.

In the meantime, concerns have since been raised about how effective these measures are. Therefore, the French medicines regulator 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.

This review will include holding a public hearing, which will enable PRAC to consider the experience of EU citizens with these medicines.

More information is available on HALMED's website.

PRAC investigates cancer medicines containing docetaxel

The PRAC is investigating the cancer medicines containing docetaxel following cases of neutropenic enterocolitis in patients in France.

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 on HALMED's website.

More information on the March 2017 PRAC meeting can be found here.