Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2017

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27/10/2017

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2017

PRAC starts two safety referrals and concludes one

PRAC recommends further restrictions for multiple sclerosis medicine Zinbryta due to risk of liver damage

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is recommending further restrictions on the use of the multiple sclerosis medicine Zinbryta (daclizumab) following a review of the medicine’s effects on the liver. Multiple sclerosis is a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord.

The review found that unpredictable and potentially fatal immune-mediated liver injury can occur during Zinbryta treatment and for up to 6 months after stopping Zinbryta.

Following the provisional measures introduced in July 2017, the PRAC adopted final measures aimed to improve liver monitoring and limit use of Zinbryta to patients who have had an inadequate response to at least two disease modifying therapies and cannot be treated with other such therapies.

More information is provided below.

PRAC starts new review of hydroxyethyl-starch containing products

The PRAC has started a new review of medicines containing hydroxyethyl-starch (HES). These products are used for the management of low blood volume caused by acute blood loss, where treatment with alternative infusion solutions known as ‘crystalloids’ is not considered to be sufficient. HES medicines are given by infusion into a vein and are used as volume expanders to prevent shock following acute bleeding.

The review has been triggered by results from two studies indicating that HES solutions are being used outside their authorised uses, including in critically ill patients and those with sepsis and kidney injury, despite restrictions introduced in 2013 to reduce the risks of kidney problems and deaths.

The PRAC invites all stakeholders (e.g. healthcare professionals, patients’ organisations, the general public) to submit data relevant to this procedure.

More information is provided below.

Review of flupirtine-containing medicines started

The PRAC has started a new review of the benefits and risks of flupirtine-containing medicines for pain relief. Flupirtine is used to treat acute pain for up to two weeks in patients who cannot use other pain medicines such as opioids or nonsteroidal anti-inflammatory medicines (NSAIDs). Additionally, patients should have their liver function monitored weekly to avoid liver problems.

The review follows evidence that flupirtine is not always being used in line with the restrictions that were introduced after an earlier EMA review in 2013, and of reports of serious liver problems associated with flupirtine use.

More information is provided below.

Agenda

 
Agenda - PRAC draft agenda of meeting 23-26 October 2017

 

Recommendation by PRAC

Zinbryta

Article-20 referral: Zinbryta

 

Summary of PRAC recommendation

 

Start of referrals

Flupirtine containing medicinal products

Article-31 referral: Flupirtine-containing medicinal products

 

Review started

PRAC list of questions

Timetable for the procedure

Annex I

Referral notification

 

Hydroxyethyl starch (HES) containing medicinal products

Article-107i referral: Hydroxyethyl starch (HES) containing medicinal products

 

Review started

PRAC list of questions to marketing authorisation holders

PRAC list of questions to stakeholders

Stakeholder's submission form

Timetable for the procedure

Annex I

Referral notification

Rationale for triggering

 

Ongoing referrals

ProcedureStatusUpdate
Article-31 referral: Paracetamol-modified releasePRAC recommendation issued on 1 September 2017Following the PRAC’s recommendation of 1 September 2017, some of the marketing authorisation holders involved with this review have requested a re-examination. Upon receipt of the grounds for their requests, the PRAC will start a re-examination, which is expected to conclude at the PRAC meeting of 27-30 November 2017.
Article-31 referral: Retinoid-containing medicinal productsUnder evaluationPRAC continued its assessment
Article-31 referral: Quinolone- and fluoroquinolone-containing medicinal productsUnder evaluationPRAC continued its assessment
Article-31 referral: Valproate and related substancesUnder evaluationPRAC continued its assessment and held a public hearing on 26 September 2017.

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