Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 February 2018

News 09/02/2018

PRAC gives recommendations for valproate, flupirtine, retinoids and interim advice for Esmya

PRAC recommends new measures to avoid valproate exposure in pregnancy

The Pharmacovigilance Risk Assessment Committee (PRAC) has recommended new measures to avoid exposure of babies to valproate medicines in the womb, due to risks of malformations and developmental problems. Medicines containing valproate have been approved nationally in the European Union (EU) to treat epilepsy, bipolar disorder and, in some countries, for the prevention of migraine.

The PRAC examined the available evidence and consulted widely with healthcare professionals and with patients, including women and their children who have been affected by valproate use during pregnancy, through written submissions, expert meetings, meetings with stakeholders and via a public hearing. The PRAC noted that women were still not always receiving the right information in a timely manner and that further measures were needed to reduce use during pregnancy. However, it was also clear that for some women, such as those with particular forms of epilepsy, valproate is the only appropriate treatment and might be life-saving.

The PRAC therefore recommended that the way valproate is used should be changed to strengthen restrictions on its use and introduce a pregnancy prevention programme including new measures to prevent pregnancy exposure.

More information is provided below.

Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing

The PRAC has recommended regular liver monitoring for women taking Esmya (ulipristal acetate) for uterine fibroids (non-cancerous growths that develop in or around the womb), following reports of serious liver injury, including liver failure leading to transplantation.

The Committee is also recommending that no new patients should be started on Esmya and no patients who have completed a course of treatment should start another one.

These are temporary measures while a review of the benefits and risks of Esmya is ongoing.

More information is provided below.

PRAC recommends that the marketing authorisations of the painkiller flupirtine be withdrawn

The PRAC has recommended that the marketing authorisations for the painkiller flupirtine be withdrawn, as the benefits of this medicine are no longer considered to outweigh its risks, particularly the risk of liver problems.

The review of flupirtine follows a previous EMA review in 2013 which introduced measures to restrict the use of the medicine because of reports of serious liver problems.

The PRAC has now reviewed the currently available data on benefits and risks from clinical trials and case reports, including cases of serious liver damage reported since the 2013 review and new studies on how the products are being used.

More information is provided below.

PRAC recommends updating measures for pregnancy prevention during retinoid use

The Committee has recommended updating the measures for pregnancy prevention and including a warning on the possible risk of neuropsychiatric disorders (such as depression, anxiety and mood changes) for retinoid medicines, treatments taken by mouth or applied as creams or gels to treat several conditions mainly affecting the skin.

The PRAC confirmed that all oral retinoids can have harmful effects on the unborn child and therefore must not be used during pregnancy. In addition, the oral retinoids acitretin, alitretinoin and isotretinoin must not be taken by women able to have children unless the conditions of a pregnancy prevention programme are met.

During its review, the PRAC assessed the available data including published literature and post-marketing reports of side effects, and also sought the views of patients and healthcare professionals in a dedicated stakeholders meeting and a successive written consultation.

More information is provided below.


PDF icon Agenda - PRAC draft agenda of meeting 5-8 February 2018

Recommendations by PRAC

Flupirtine-containing medicinal products

Article-31 referral: Flupirtine-containing medicinal products

PDF icon Summary of recommendation

Retinoid-containing medicinal products

Article-31 referral: Retinoid-containing medicinal products

PDF icon Summary of recommendation

Valproate and related substances

Article-31 referral: Valproate and related substances

PDF icon Summary of recommendation

Temporary recommendation by PRAC


Article-20 procedure: Esmya

PDF icon Summary of temporary recommendation

Ongoing referrals

Article-20 procedure: EsmyaUnder evaluationPRAC continued its assessment and gave interim advice
Article-31 referral: Quinolone- and fluoroquinolone-containing medicinal productsUnder evaluationPRAC continued its assessment
Article-20 procedure: XofigoUnder evaluationPRAC continued its assessment

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