The South African Health Products Regulatory Authority
(SAHPRA) has issued new safety information on the use of the oral, injectable
and inhalation quinolone/fluoroquinolone antibiotics following a recent review
of the disabling and potentially long-lasting side-effects associated with
these medicines.

It showed that some patients may experience adverse events
that can impair their normal daily activities which can take a long time to go
away (weeks to months) or that may not be fully reversible in a small
percentage of patients even after the antibiotic had been stopped for up to 12
months or longer.

Quinolone and flouroquinolone antibiotics registered in
South Africa are nalidixic acid, pipemidic acid, ciprofloxacin, ofloxacin,
moxifloxacin, gemifloxacin, norfloxacin, levofloxacin. The majority of adverse
events relate to muscles, ligaments, joints, and nervous system, including some
psychiatric disorders, heart, blood vessel and blood glucose.

Due to the new safety information, the use of these
antibiotics has changed and patients are requested to consult with their
general practitioners/specialists for more information and reassessment of
their treatment with these antibiotics.

Patients are also urged to read the patient information
leaflet that is contained in the package of these antibiotics or request their
pharmacist for a copy of the patient information leaflet.

Healthcare providers and patients are requested to report
any adverse events to the National Adverse Drug Event Monitoring Centre at 021
447 1618 or the SAHPRA pharmacovigilance office at 012 395 9133 or using the
adverse drug reaction reporting form which can be accessed at
ARF1 v4.pdf
and e-mail it to

The review on the potentially disabling side-effects was
conducted by the  European Medicines
Agency’s (EMA) Pharmacovigilance
Risk Assessment Committee
and incorporated the views of patients, healthcare professionals and academics
presented at the EMA’s public hearing on fluoroquinolone and quinolone
antibiotics in June this year.

Following its evaluation of these side effects, the PRAC
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, PRAC said in a statement in October.

It recommended that the remaining fluoroquinolone
antibiotics should not 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
  • 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
  • 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