Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 July 2017

News 07/07/2017

PRAC concluded two referrals and issued provisional measures for treatment of multiple sclerosis; PRAC aware of contraindication for valproate in France

Injectable methylprednisolone products containing lactose must not be given to patients allergic to cow's milk proteins

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that injectable methylprednisolone medicines containing lactose, which are approved to treat the symptoms of severe allergic reactions, must not be used in patients with a known or suspected allergy to the proteins in cow's milk. Patients being already treated for an allergic reaction with methylprednisolone should have their treatment stopped if their symptoms worsen or they develop new symptoms.

PRAC also recommended that companies should remove cow's milk proteins from the preparation.

More information is available below.

PRAC confirms restrictions on the use of linear gadolinium agents

PRAC has confirmed its PDF icon previous conclusion from March 2017 that there is convincing evidence of gadolinium deposition in brain tissues following use of gadolinium contrast agents.

The Committee confirms restrictions on the use of linear gadolinium agents, while the benefit-risk balance of certain linear agents is no longer favourable.

More information is available below

PRAC restricts use of multiple sclerosis medicine Zinbryta as interim measure

PRAC is provisionally restricting the use of the multiple sclerosis medicine Zinbryta (daclizumab) to patients with highly active relapsing disease that failed to respond to certain other treatments, and to patients with rapidly evolving relapsing disease who cannot be treated with other medicines.

Patients with liver injury must not be given the medicine. Doctors should continue to monitor the liver function of patients receiving the medicine and closely monitor patients for signs and symptoms of liver injury.

This recommendation is an interim measure taken to protect public health while the review of Zinbryta is still ongoing.

More information is available below.

Update on valproate

PRAC noted that a contraindication on the use of valproate for bipolar disorder during pregnancy and in women of childbearing potential not using effective contraception is to be introduced in France. The PRAC had been kept aware of this action, which is based on the same data used to trigger its ongoing EU review. PRAC's most recent recommendation is that valproate should never be used in pregnancy or in women of childbearing potential not using effective contraception, unless there is no alternative. Further EU-wide recommendations aiming to ensure the most appropriate use of these medicines in all their indications will be made in the next few months once the PRAC has completed its evaluation.

This ongoing review will include a public hearing involving patients, prescribers and other stakeholders in order to best inform the final recommendations. More information about the registration process for the public hearing will be made available on the EMA's website on 11 July 2017.

While the review is ongoing, patients prescribed valproate who have any concerns about their medication should discuss them with their healthcare professionals and should not stop their treatment without consultation.


PDF icon Agenda - PRAC draft agenda of meeting 3-6 July 2017

Recommendations by PRAC

Gadolinium-containing contrast agents

Article-31 referral: Gadolinium-containing contrast agents

PDF icon Summary of PRAC recommendation in context of re-examination

Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions

Article-31 referral: Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions

PDF icon Summary of PRAC recommendation

Provisional recommendation by PRAC


Article-20 procedure: Zinbryta

PDF icon Summary of provisional recommendation

Ongoing referrals

Article-31 referral: Factor VIIIUnder evaluationAs per the update of 9 June 2017, following the PRAC's May 2017 recommendation, a marketing authorisation holder involved with this referral procedure has requested a re-examination. Upon receipt of the grounds for their request, the PRAC will start a re-examination, which is expected to conclude at the PRAC meeting of 29 August-1 September 2017.
Article-31 referral: Paracetamol-modified releaseUnder evaluationPRAC continued its assessment
Article-31 referral: Retinoid-containing medicinal productsUnder evaluationPRAC continued its assessment
Article-31 referral: Systemic and inhaled quinolone and fluoroquinolone antibioticsUnder evaluationPRAC continued its assessment
Article-31 referral: Valproate and related substancesUnder evaluationPRAC continued its assessment and decided to organise a public hearing on 26 September 2017. Registration to open on 11 July 2017.
Article-20 referral: ZinbrytaUnder evaluationPRAC has issued provisional measures to ensure that Zinbryta continues to be used as safely as possible while a review of its liver safety is ongoing.

Related content

How useful was this page?

Add your rating