PRAC October 2018 – Recommendation to restrict the use of fluoroquinolone and quinolone antibiotics

date: 09/11/2018

During its meeting of October 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended restricting the use of fluoroquinolone and quinolone antibiotics.

The PRAC has recommended restricting the use of fluoroquinolone and quinolone antibiotics (used by mouth, injection or inhalation) following a review of disabling and potentially long-term side effects reported with these medicines. The review incorporated the views of patients, healthcare professionals and academics presented at EMA’s public hearing on fluoroquinolone and quinolone antibiotics in June 2018.

Very rarely, patients treated with fluoroquinolone or quinolone antibiotics have suffered long-term and disabling side effects, mainly involving muscles, tendons and bones and the nervous system.  

Following its evaluation of these side effects, the PRAC has recommended that some medicines, including all those that contain a quinolone antibiotic, should be removed from the market. This is because they are authorised only for infections that should no longer be treated with this class of antibiotics.

The PRAC recommended that the remaining fluoroquinolone antibiotics should:

- no longer be used

  • to treat infections that might get better without treatment or are not severe (such as throat infections);
  • for preventing traveller’s diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder);
  • to treat patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic;
  • to treat mild or moderately severe infections unless other antibacterial medicines commonly recommended for these infections cannot be used;

- be used with caution especially for the elderly, patients with kidney problems, patients who have had an organ transplantation or those who are being treated with a systemic corticosteroid. These patients are at higher risk of tendon injury caused by fluoroquinolone and quinolone antibiotics.

The PRAC also recommended that healthcare professionals should advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons or bones (inflamed or torn tendon, muscle pain or weakness, and joint pain or swelling …) or the nervous system (feeling pins and needles, tiredness, depression, confusion, suicidal thoughts, sleep disorders, vision and hearing problems, and altered taste and smell …).

Prescribing information of individual fluoroquinolone antibiotics will be updated to reflect the restricted use.

The PRAC recommendations will now be sent to EMA’s Committee for Medicinal Products for Human Use (CHMP), which will adopt the Agency’s final opinion.

The following fluoroquinolone containing products are authorised and marketed in Belgium:

Avelox, Ciprofloxacine EG, Ciprofloxacine Fresenius Kabi, Ciprofloxacine Mylan, Ciprofloxacine Sandoz, Ciprofloxacine Teva, Ciproxine, Levofloxacine EG, Levofloxacine Fresenius Kabi, Levofloxacine Mylan, Levofloxacine Sandoz, Levofloxacine Teva, Moxifloxacin Apotex, Moxifloxacin Mylan, Moxifloxacin Sandoz, Moxifloxacine EG, Moxifloxacine Fresenius Kabi, Moxifloxacine Teva, Norfloxacine EG, Ofloxacine EG, Ofloxacine Mylan, Tarivid, Tavanic.

More information is available on the EMA website.


Last updated on 09/11/2018