Antibiotics

EMA to hold public hearing on the safety of quinolone and fluoroquinolone

The European Medicines Agency is set to hold a public hearing on the safety of quinolone and fluoroquinolone, as part of a Pharmacovigilance Risk Assessment Committee review.

A is to be held by the European drugs safety watchdog.

The European Medicines Agency (EMA) is hosting the event as part of the ongoing safety review into this class of antibiotics by its Pharmacovigilance Risk Assessment Committee (PRAC).

The agency is keen to hear from patients, researchers and health professionals — including pharmacists — who would like to give evidence at the hearing on 13 June 2018.

It is particularly interested in cases where patients with mild infections, who could have been treated with alternative antibiotics, suffered serious side effects after taking quinolone and fluoroquinolone.

The hearing will focus on three issues: the role of quinolones and fluoroquinolones in the treatment of infections, the risks associated with their use, and what steps the EMA can take to improve patient safety.

The PRAC safety review was triggered at the request of the German medicines authority, the Federal Institute for Drugs and Medical Devices, in February following reports of long-lasting side effects in its national database and published literature.

The public hearing is the second of its kind organised by the EMA as part of a PRAC review into drug safety. The first took place last September 2017 when people were invited to give evidence into the safety of valproate, after it was linked to foetal abnormalities. In March 2018, the EMA endorsed tighter valproate safety controls around exposing women to the drug during pregnancy.

Anyone interested in giving evidence to the quinolone and fluoroquinolone public hearing should complete an application form by 30 April 2018. The form can be found on the EMA website.

Citation: The Salvadore DOI: 10.1211/PJ.2018.20204653

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