Re-examining the safety of fluoroquinolones

Re-examining the safety of fluoroquinolones

A review into the use of fluoroquinolones has found discrepancies in the safety data issued by regulatory bodies.

Fluoroquinolones are commonly prescribed family of antibiotics. Fluoroquinolones are effective against a wide range of disease-causing bacteria and are a widely used treatment for acute respiratory infections and urinary tract infections.

There are rare incidents of fluoroquinolones being associated with serious side effects, such as tendon ruptures, nervous system and psychiatric problems, aortic dissections, and aneurysms.

Restricting the use of fluoroquinolones

These associations led many regulatory agencies to recognise the permanent toxicity of antibiotics.  The U.S. Food and Drug Administration, European Medicines Agency, and UK’s Medicines and Healthcare products Regulatory Agency have all advised doctors against prescribing fluoroquinolones as the first option of therapy.

However, a new study examining the global approach to fluoroquinolones has revealed some countries have not restricted their use.

“What we found that was quite striking is that Australia, New Zealand, Japan and Canada don’t have these warnings for disabling effects for fluoroquinolones,” said Dr Robert Baldock from the School of Pharmacy and Biomedical Sciences at the University of Portsmouth.

“And so, what this paper does is examine the evidence that was used to make these policies in the first place, and as a result calls for a global harmonisation of the safety warnings,” he added.

The study is part of a collaborative project between the University of Portsmouth, York College of Pennsylvania, University of South Carolina, and the City of Hope Comprehensive Cancer Center in Duarte, California.

The paper has been published in the journal Expert Opinion on Drug Safety.

A new framework for regulatory bodies

The study provides details of how fluoroquinolones are used globally and outlines a framework for regulatory agencies to address reports of serious side effects in patients.

“As adverse reactions can be diverse and underreported, one of the challenges is identifying the number of serious adverse events there are or have been,” added Dr Baldock.

“So many patients who report chronic fatigue, pain or psychiatric problems either remain undiagnosed or misdiagnosed, often with things like chronic fatigue syndrome. If regulatory bodies can resolve this issue, it could lead to more robust and universal safety data.”

The researchers have recommended that manufacturers sponsor new research to identify what causes a patient these suffer serious side effects after taking fluoroquinolones.

“What we need is a strategy to mitigate these risks. And in doing so, we need the research to uncover the molecular causes of those adverse reactions to the antibiotics,” said Dr Cecilia Bove, from the Department of Biological Sciences at York College of Pennsylvania.

“With this information, we can determine strategies to mitigate the symptoms and provide more data against the over-prescription of these drugs. That way we can continue to use fluoroquinolones and benefit from their bacteria-fighting capabilities when other strategies are not sufficient.”

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