Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 May 2018

News 18/05/2018

PRAC concludes two referrals, maintains recommendation on HES solutions for infusion and issues precautionary advice on HIV medicine

PRAC confirms its recommendation to suspend hydroxyethyl-starch (HES) solutions for infusion in the EU

Following a request from the European Commission to look into certain aspects related to the suspension of the marketing authorisations for hydroxyethyl starch (HES) solutions for infusion, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed its recommendation to suspend these products across the European Union (EU).

In January 2018, the PRAC PDF icon recommended suspending the marketing authorisations for HES solutions for infusion because they continued to be used in critically ill patients and patients with sepsis despite restrictions introduced in 2013 to reduce the risk of kidney injury and death in such patients.

This recommendation was endorsed by the CMDh and sent to the European Commission. In April 2018, the Commission requested the PRAC to consider whether suspending the marketing authorisations could result in an unmet medical need. It also requested the PRAC to consider the feasibility and likely effectiveness of additional risk minimisation measures.

After having assessed the relevant data on these specific aspects, the PRAC confirmed its previous recommendation that HES solutions for infusion should be suspended. The PRAC recommendation will now be sent to the CMDh for consideration at its meeting on 28-30 May 2018.

PRAC recommends new measures to minimise risk of rare but serious liver injury with Esmya for fibroids

The PRAC has completed its review of Esmya (ulipristal acetate), used to treat moderate to severe symptoms of uterine fibroids (benign tumours of the womb), following reports of serious liver injury.

After considering all the evidence, the PRAC concluded that the medicine must not be used in women with liver problems and that certain other patients may start new treatment courses provided they have regular liver tests. In addition, PRAC recommended that Esmya should be used for more than one treatment course only in women who are not eligible for surgery.

More information is provided below.

PRAC review of Zinbryta confirms medicine's risks outweigh benefits

Finalising its review of Zinbryta (daclizumab beta), the PRAC has confirmed the finding from its preliminary assessment that this multiple sclerosis medicine poses a risk of serious and potentially fatal immune reactions affecting the brain, liver and other organs.

On 6 March 2018, while the review was ongoing, the PRAC recommended suspension of the marketing authorisation of Zinbryta in the EU and a recall of the product from pharmacies and hospitals, following 12 reports of serious inflammatory brain disorders worldwide, including encephalitis and meningoencephalitis. On 27 March 2018, the European Commission withdrew the marketing authorisation of the medicine at the request of the marketing authorisation holder Biogen Idec Ltd.

The PRAC has now concluded its review of the available evidence on Zinbryta and maintained its initial recommendation. However, there are no immediate consequences of the PRAC's review as Zinbryta is no longer authorised in the EU.

More information is provided below.

New study suggests risk of birth defects in babies born to women on HIV medicine dolutegravir

The PRAC is evaluating preliminary results from a study which found four cases of birth defects such as spina bifida (malformed spinal cord) in babies born to mothers who became pregnant while taking the HIV medicine dolutegravir.

While the Committee is assessing the new evidence, it has issued precautionary advice. Dolutegravir should not be prescribed to women seeking to become pregnant and women who can become pregnant should use effective contraception while taking dolutegravir medicines.

More information is provided below.


PDF icon Agenda - PRAC draft agenda of meeting 14-17 May 2018

Recommendations by PRAC


Article-20 procedure: Esmya

PDF icon Summary of recommendation


Article-20 procedure: Zinbryta

PDF icon Summary of recommendation

Safety signal evaluation

New study suggests risk of birth defects in babies born to women on HIV medicine dolutegravir

Ongoing referrals

Article-31 referral: Quinolone- and fluoroquinolone-containing medicinal productsUnder evaluationEMA received a total of 113 registrations for the public hearing and reviewed all applications to compile a list of speakers. The PRAC adopted the agenda and the list of proposed speakers. EMA will now contact all registrants to inform them about the outcome of the selection. Further information will be made available soon.
Article-20 procedure: XofigoUnder evaluationPRAC discussed a list of experts for an ad-hoc expert group meeting and continued its assessment.
Article-31 procedure: Methotrexate containing medicinal productsUnder evaluationPRAC continued its assessment.

Related content

How useful was this page?

Add your rating