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Pharmacovigilance

EMA starts safety referral for prostate cancer drug

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has begun two new safety-related referrals and confirmed its recommendation to suspend modified-release paracetamol-containing medicines from the market.

At its most recent meeting, held on 27–30 November 2017, the PRAC began a safety review for ulipristal acetate (Esmya, Allergan), a drug used to treat non-cancerous tumours of the womb. The safety of ulipristal acetate was called into question after four reports of serious liver injury in patients using the drug, three of which resulted in liver transplantation.

The committee will now evaluate all available data and determine whether there are adverse implications for the use of this treatment.

The second medicine to be reviewed was radium-223 dichloride (Xofigo, Bayer) after an increased risk of death and fractures was reported in an ongoing trial comparing radium-223 dichloride with placebo, both in combination with abiraterone acetate (Zytiga, Janssen) and prednisone or prednisolone.

The trial included patients with prostate cancer but no or mild symptoms. Radium-223 dichloride is already authorised for use in patients whose prostate cancer has spread to the bones and is symptomatic.

The PRAC will now review the full results of the trial and other available data to assess the safety of radium-223 dichloride.

The PRAC also confirmed its recommendation, made in September 2017, that modified- or prolonged-release paracetamol-containing medicines, which are designed to release paracetamol slowly over a longer period, should be suspended from marketing.

This was in view of the risks to patients as a result of the complex way the medicine releases paracetamol into the body after an overdose.

The re-examination was requested by two companies marketing modified-release paracetamol or modified-release paracetamol with tramadol.

Also at the meeting, the PRAC adopted a revised strategy, launched in January 2016, to measure the impact of pharmacovigilance activities. The strategy aims to improve safety monitoring practices and determine which activities are most successful, and was revised to reflect how major regulatory interventions benefit patients’ health.

Progress was also made in its evaluation of valproate and related substances, and a final recommendation is expected in February 2018.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20204084

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