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EMA announces second-ever public hearing on high-use antibiotics

Published on 12/04/18 at 10:20am

The EMA has announced, following the first-ever public hearing on valproate, that it would hold a second public hearing regarding the use of quinolone and fluoroquinolone antibiotics.

The date is set for 13 June of this year and will hear from patients, doctors, nurses, pharmacists and researchers on their experience with the widely prescribed antibiotics.

Questions over the safety of the antibiotics have been raised for a number of years because, in rare instances, the antibiotics have been associated with severe side-effects.

Many of the common side-effects have been reported to be regarding muscle and tendon injuries or in the joints; however, in certain cases, there have been reported serious problems that developed after the use of the antibiotics related to the central nervous system.

“The public hearing provides citizens with the opportunity to contribute to this review. Their experiences and views will complement the available scientific evidence and enrich PRAC’s deliberations,” said Guido Rasi, EMA’s Executive Director. “Public hearings underline our commitment to include patients and healthcare professionals in our decision-making.”

The public hearing will put three questions before each speaker, which are:

  1. What is your view on the role of quinolones and fluoroquinolones in the treatment of infections?
  2. What is your view of the risks associated with quinolone and fluoroquinolone use?
  3. In your opinion, what further measures could be taken to optimise the safe use of quinolones and fluoroquinolones?

The exact reasons why the antibiotics could be causing such a variety of complications are not yet known, though research has been done that indicates several potential hypotheses.

One idea is that, in certain people, the drugs interrupt the healthy action of the mitochondria, which provide energy for cells. Mitochondria have striking similarities to bacteria cells and the theory suggests that the antibiotics could be inadvertently attacking the mitochondria mistaking them for foreign bacteria.

Another idea showed that of 24 people who reported neuropsychiatric side effects as a result of treatment with the antibiotics, 57% shared a rare gene variant usually only found in 9% of the population – suggesting adverse events could be related to genetic differences.

The EMA will use the public hearing evidence to determine the risks posed by the antibiotics.

Ben Hargreaves

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