Fluoroquinolones: serious side effects finally taken seriously

The fluoroquinolone class of antibiotics is in the spotlight. The High Authority of Health responded to a right of alert exercised by France Assos Santé concerning the detection and management of serious adverse effects related to these drugs. What are the next steps to guarantee patient safety? Analysis.

Serious complications

Fluoroquinolones, a class of antibiotics widely used to treat various bacterial infections, are now under scrutiny due to their potentially serious adverse effects. On Monday, the French National Authority for Health (HAS) issued a press release following a right of alert, highlighting the risks associated with these drugs.

France Assos Santé had asked the HAS to develop recommendations for identifying and managing complications of fluoroquinolones, marketed under different names (Oflocet, Ciflox or Tavanic).

Complications of fluoroquinolones can include musculoskeletal effects with disability, peripheral neuropathies, neurological and psychiatric disorders, hearing disorders, cardiac problems, etc. Last March, according to a France Info report, the Paris prosecutor’s office opened an investigation for unintentional injuries and deception, after several complaints about the adverse effects of fluoroquinolones. And the number of victims could be very high. Last March, an association denounced “6 million poisonings in France”.

Doctors urged to be cautious, patients better informed

To address this issue, the HAS recommends several measures.

The next actions of the HAS

Beyond this stated desire, the High Authority for Health is committed to carrying out two actions:

• The HAS will work on the dissemination of a information document for healthcare professionals likely to encounter patients affected by these complications (general medicine, cardiology and cardiac surgery, dermatology, physical medicine and rehabilitation, neurology, ophthalmology, psychiatry, rheumatology, etc.). The objective is to “to raise awareness among professionals of the importance of identifying these complications, to encourage them to report them via the pharmacovigilance system and to specify the conduct to be adopted in terms of the management of patients presenting complications linked to the administration of fluoroquinolones; it will be developed in collaboration with the national professional councils and user associations“.
• The HAS will also update its evaluation report on “targeted biopsies in the diagnosis of prostate cancer” for the use of fluoroquinolones should be re-evaluated.

The HAS finally insists on the necessity, “for all competent institutions, to seek new vectors to strengthen awareness among professionals on the conditions for the correct prescription of fluoroquinolones“.

This response from the HAS recognises the need for better management of the risks linked to these antibiotics but does not, to date, provide much more information than the warnings of caution from various learned societies and the National Agency for the Safety of Health Products.