European Medicines Agency (EMA) restricts quinolones and fluoroquinolones antibiotics

Life Sciences - PRAC Quinolones

María is a pharmacovigilance expert and a Life Sciences’ Consultant at ALTEN. In this article, she talks about the potential risks of using quinolones and fluoroquinolones antibiotics.

What is the risk of using quinolones and fluoroquinolones?

The Pharmacovigilance Risk Assessment Committee (PRAC) has evaluated the impact of the long-lasting disabling and potentially irreversible adverse reactions that this pharmacological group could cause in the benefit/risk balance that affect to the nervous system and the musculoskeletal system.

Among all the adverse reactions that affect the musculoskeletal system, there are tendonitis, myalgia, muscle pain or weakness, joint pain or arthralgia. Those that affect the nervous system are tiredness, depression, problems with memory, sleeping, vision and hearing, and altered taste and smell.


What kind of measures will be taken?

Until this decision becomes effective, the recommendations for the medical professionals are:

  • To not prescribe quinolones or fluoroquinolones antibiotics to treat the mild and self-limited infections. They should be used only when other necessary antibiotics are neither effective or poorly tolerated.
  • The professionals have to take into account that there is a higher risk to suffer tendonitis or joint pain for some patients. Which are the elderly ones, who have a transplant or are following a corticosteroids treatment?
  • Those patients that are going to have quinolones or fluoroquinolones antibiotics must know that they should stop with their treatment in case they have side effects in the nervous or in the musculoskeletal system.

PRAC recommendations have to be confirmed by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Then, the European Commission has to accept them, so they’ll be effective.


*Reference: EMA, 5 October and 16 November 2018 (

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