EMA recommends to restrict the use of fluoroquinolone and quinolone antibiotics

30 October 2018

GMP News

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (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-lasting 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-lasting 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 not be used:

The remaining fluoroquinolone antibiotics should 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.

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