Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2017

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01/12/2017

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2017

PRAC starts two safety referrals and reaches conclusion on re-examination

PRAC starts review of Esmya for treatment of uterine fibroids

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of Esmya (ulipristal acetate), a medicine used to treat uterine fibroids (non-cancerous tumours of the womb). This follows four reports of serious liver injury, three of which ended in liver transplantation, in patients treated with this medicine.

The PRAC has made an initial assessment of the cases of liver injury and considered that Esmya could be the cause. The Committee will now evaluate all available data and determine whether there are any implications for the use of this treatment.

More information is provided below.

PRAC issues warning about use of prostate cancer medicine Xofigo in combination with Zytiga and prednisone or prednisolone

The PRAC has started an investigation on the increased risk of death and fractures reported in an ongoing clinical trial with Xofigo (radium-223 dichloride). The clinical trial is comparing Xofigo with placebo, both given in combination with Zytiga (abiraterone acetate) and prednisone or prednisolone. It includes prostate cancer patients with no symptoms or only mild symptoms, such as pain.

Xofigo is currently authorised for use in patients whose prostate cancer has spread to the bones and is causing symptoms. Zytiga is used in men with metastatic castration-resistant prostate cancer, a type of advanced prostate cancer that is resistant to medical or surgical treatments that lower testosterone and has spread to other parts of the body. Prednisone or prednisolone provide relief for inflamed areas of the body.

The PRAC will review the full results of this clinical trial and other available data to evaluate their impact on the authorised use of Xofigo.

More information is provided below.

PRAC confirms that modified-release paracetamol containing medicines should be suspended from market

The PRAC has confirmed its recommendation that modified- or prolonged-release paracetamol containing medicines (designed to release paracetamol slowly over a longer period than the usual immediate-release medicines) should be suspended from marketing.

This follows a re-examination of the previous recommendation that was made in September 2017 by the Committee. The re-examination was requested by two companies marketing modified-release paracetamol or modified-release paracetamol with tramadol.

More information is provided below.

Revised strategy to measure the impact of pharmacovigilance is adopted

The PRAC adopted a revision to its strategy to measure the impact of pharmacovigilance activities. The strategy was launched in January 2016, with the aim to improve safety monitoring practices and determine which activities are most successful. The strategy has been revised to reflect, among others, how major regulatory interventions benefit patients’ health.

For more information, see Pharmacovigilance: overview.

Agenda

 
Agenda - PRAC draft agenda of meeting 27-30 November 2017

 

Start of referrals

Esmya

Article-20 procedure: Esmya

 

Review started

PRAC list of questions

Timetable for the procedure

Referral notification

 

Xofigo

Article-20 procedure: Xofigo

 

Review started

PRAC list of questions

Timetable for the procedure

Referral notification

 

Recommendation by PRAC

Paracetamol-modified release

Article-31 referral: Paracetamol-modified release

 

Summary of PRAC recommendation in context of re-examination

 

Ongoing referrals

ProcedureStatusUpdate
Article-31 referral: Flupirtine-containing medicinal productsUnder evaluationPRAC continued its assessment
Article-107i referral: Hydroxyethyl starch (HES) containing medicinal productsUnder evaluationPRAC continued its assessment
Article-31 referral: Retinoid-containing medicinal productsUnder evaluation

PRAC adopted a list of outstanding issues to be addressed by the marketing-authorisation holders.

The Committee also agreed to consult patients and healthcare professionals in writing and adopted a list of questions addressed to them.

Article-31 referral: Quinolone- and fluoroquinolone-containing medicinal productsUnder evaluationPRAC continued its assessment
Article-31 referral: Valproate and related substancesUnder evaluationProgress has been made as the PRAC continued its assessment and considered further feedback from scientific experts and stakeholders. The PRAC recommendation is expected in February 2018.

 

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