Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 July 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
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.
Agenda
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Agenda - PRAC draft agenda of meeting 3-6 July 2017
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Recommendations by PRAC
| Gadolinium-containing contrast agents |
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Article-31 referral: Gadolinium-containing contrast agents
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| Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions |
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Provisional recommendation by PRAC
| Zinbryta |
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Article-20 procedure: Zinbryta
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Ongoing referrals
| Procedure | Status | Update |
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| Article-31 referral: Factor VIII | Under evaluation | As 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 release | Under evaluation | PRAC continued its assessment |
| Article-31 referral: Retinoid-containing medicinal products | Under evaluation | PRAC continued its assessment |
| Article-31 referral: Systemic and inhaled quinolone and fluoroquinolone antibiotics | Under evaluation | PRAC continued its assessment |
| Article-31 referral: Valproate and related substances | Under evaluation | PRAC continued its assessment and decided to organise a public hearing on 26 September 2017. Registration to open on 11 July 2017. |
| Article-20 referral: Zinbryta | Under evaluation | PRAC 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. |