EMA to hold public hearing on quinolone and fluoroquinolone antibiotic safety

The European Medicines Agency will be holding the hearing following reports of long-lasting, serious side effects of quinolone and fluoroquinolone antibiotics.

Europeans Medicines Agency building

The European Medicines Agency (EMA) has announced that its Pharmacovigilance Risk Assessment Committee (PRAC) will hold a public hearing on quinolone and fluoroquinolone antibiotics, as part of an ongoing safety review into the drugs.

“The PRAC, taking into account this increased interest, considered it would be useful to hold a hearing to better understand the public’s views on the risks associated with these antibiotics, and the feasibility of certain measures to optimise their safe use,” the regulatory agency said in a statement.

The safety review was launched at the request of the German medicines authority after reports of long-lasting, serious side effects, primarily affecting the muscles, joints and nervous system. The outcome will determine whether the EMA recommends changes to the way systematic and inhaled forms of the drugs are used, and whether to introduce measures to minimise their risks.

As of 2017, the PRAC now holds public hearings to gather input from interested parties about their experiences with medications under review, which could include patients, their families, doctors, nurses, pharmacists and researchers.

The hearing on quinolones and fluoroquinolones is due to take place at the PRAC meeting in June 2018. It marks only the second time that the PRAC has held such a hearing during a safety review, the first being the safety review for epilepsy drug sodium valproate in September 2017.

A temporary recommendation contraindicating the use of Xofigo (radium-223 dichloride) with Zytiga (abiraterone acetate) and prednisone/prednisolone in metastatic prostate cancer was also decided at the March 2018 PRAC meeting, after preliminary data from an ongoing clinical trial showed an increased risk of death and bone fractures, compared with Zytiga and prednisone/prednisolone alone.

The EMA said it has put the interim recommendation in place while it continues its safety review of Xofigo.

Last updated
The Pharmaceutical Journal, EMA to hold public hearing on quinolone and fluoroquinolone antibiotic safety;Online:DOI:10.1211/PJ.2018.20204559

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