Valproate and docetaxel under scrutiny from EMA Committee

The Pharmacovigilance Risk Assessment Committee (PRAC) reviewed valproate and docetaxel-containing medicines for safety in treating pregnant woman and cancer sufferers

The PRAC started a view on the use of valproate in pregnant women

At its March meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) started the review of docetaxel-containing medicines in the context of a safety signal and discussed three ongoing referrals.

New review of valproate use in pregnancy

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 EU to treat epilepsy, bipolar disorder and in some countries, migraine.

In a previous review in 2014 the Agency 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. 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 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.

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

Review of 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 is completed.

Suspended authorisation for gadolinium contrast agents

PRAC concluded the assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations. Detailed information on this can be found here.

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