Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 July 2018

News 13/07/2018

PRAC recommends restricting use of prostate cancer medicine Xofigo

Following a review of data showing a possible risk of earlier death and an increase in fractures with Xofigo (radium-223 dichloride), the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommended restricting the use of this cancer medicine to patients who have had two previous treatments for metastatic prostate cancer or who cannot receive other treatments.

The PRAC also confirmed its previous interim recommendation that the medicine must not be used with Zytiga and prednisone/prednisolone.

More information is provided below.

PRAC elects new Chair

The July 2018 meeting of the PRAC was the last plenary meeting chaired by Dr June Raine, who retires as Chair after serving for two three-year mandates, the maximum allowed by the legislation. EMA would like to thank Dr Raine for her leadership and vision that were instrumental in establishing the PRAC as the leading body on the safety of medicines in the European Union since its inception in 2012.

The Committee elected Dr Sabine Straus from the Netherlands as the new Chair to take over from Dr Raine. Dr Straus is a member of the Dutch national competent authority – the Medicines Evaluation Board (MEB), with strong expertise in pharmacovigilance. She has been a member of the PRAC since 2012.

Agenda

PDF iconAgenda - PRAC draft agenda of meeting 9-12 July 2018

Recommendation by PRAC

Article-20 procedure: Xofigo

PDF iconSummary of PRAC recommendation

Ongoing referrals

ProcedureStatusUpdate
Article-31 referral: Quinolone- and fluoroquinolone-containing medicinal productsUnder evaluationPRAC adopted a list of outstanding issues
Article-31 procedure: Methotrexate containing medicinal productsUnder evaluationPRAC continues its assessment

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