The European Medicines Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of fluoroquinolone use by mouth, injection or inhalation, and that quinolone be removed from the market.
The EMA defines fluoroquinolones and quinolones as a class of broad-spectrum antibiotics that are active against bacteria of both gram-negative and gram-positive classes.
The PRAC, which incorporated the views of patients, healthcare professionals and academics in the decision, assessed reports of patients that had been treated with these antibiotics, and who, albeit rarely, suffered long-lasting and disabling side effects, “mainly involving muscles, tendons and bones and the nervous system.”
The Committee’s recommendation to remove all quinolone antibiotics from market relates to a change in treatment protocol, wrote this agency: “[These antibiotics] are authorised only for infections that should no longer be treated with this class of antibiotics.”
Teva to ‘fully comply’ with the final endorsed decision
As a marketing authorisation holder of fluoroquinolone products, Teva Pharmaceutical Industries also contributed to the PRAC review.
The firm markets a number of fluoroquinolone-containing generics antibiotics in Europe – Ciprofloxacin, Ofloxacin, Levofloxacin, Norfloxacin and Moxifloxacin – but not any quinolone antibiotics in this region.
While the cause of the disabling side effects are not yet fully understood, the firm stated, “there are several suggestions of the cause, the most often described one being the physiological stress on the body, resulting in cell toxicity.”
The PRAC recommendations will now be sent to the EMA’s Committee for Medicinal Products for Human Use (CHMP), and on to the European Commission.
In an emailed statement, Teva highlighted that the PRAC’s review has not yet been endorsed by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). “The decision was not triggered by any quality issue but rather because those medicines should not be authorised for serious infections only.”
The company awaits the MHRA findings and conclusions and will fully comply with the final endorsed decision on any appropriate actions, we were told.