Medicines regulator warns of severe side effects of two antibiotics
Medication could affect muscles, joints, tendons as well as nervous system
SA's medicines regulator has warned patients of disabling and potentially permanent side effects associated with quinolone and fluroquinolone antibiotics, and urged people taking these medicines to consult their doctors on whether to continue using them.
Quinolone and fluroquinolones are broad-spectrum antibiotics that are widely used in SA, particularly in the private sector. They are frequently prescribed for respiratory and urinary tract infections, as well as more severe conditions.
New safety information indicated a small percentage of patients could experience severe side effects lasting months or years after they stopped taking the drugs, said the South African Health Products Regulatory Authority (Sahpra). The side effects include problems with muscles, joints, tendons and the nervous system. As a result, the use of these antibiotics has been changed, it said.
Quinolone and flouroquinolone antibiotics registered in SA include nalidixic acid, pipemidic acid, ciprofloxacin, ofloxacin, moxifloxacin, gemifloxacin, norfloxacin and levofloxacin. They are manufactured and sold by a large number of pharmaceutical companies. Ciprofloxacin is often used to treat urinary tract infections, while moxiflocacin is used for tuberculosis.
Sahpra is currently reviewing the registration of nalidixic acid and pipemidic acid, according to Flora Matlala, who heads its pharmacovigilance unit. Pipemidic acid is sold by Takeda, while nalidixic acid is sold by local pharmaceutical manufacturers Aspen Pharmacare and Adcock Ingram, according to the database of medicines published by the national health department.
There was growing evidence that the risks associated with quinolone and fluroquinoline drugs outweighed their benefits for uncomplicated infections that could be treated with other antibiotics such as penicillins, said Marc Blockman, a clinical pharmacologist at the University of Cape Town. Quinolone and flouroquinolone antibiotics had unfortunately become “go to” drugs for infections such as bronchitis and urinary tract infections, he said.
However, these antibiotics still had a role to play in treating potentially life-threatening cases, such as deep-seated infections where there was a risk of organ failure, he said.
Sahpra’s move is broadly in line with other medicine regulators, which have tightened the use of these fluroquinolone and quinolone antibiotics as more evidence emerges of their risks. However, Sahpra has not gone as far as the European Medicines Agency (EMA), which in November recommended that the marketing authorisation of medicines containing cinoxacin, flumequine, nalidixic acid and pipemidic acid should be suspended, while the use of the remaining fluoroquinolone antibiotics should be restricted.
The EMA said they should not be used to treat mild or moderate bacterial infections unless alternatives could not be used, or for preventing lower urinary tract infections and travellers’ diarrhoea.
The EMA’s recommendation, which will be forwarded to the European Commission to be made legally binding on the EU, follows a safety review it began in 2017 in the wake of reports of long-lasting side effects.
It warned patients to stop taking fluoroquinolones and contact their doctor at the first sign of tendon injury, pain, pins and needles or tingling, difficulty walking, or swelling in the arms or legs. Other serious side effects included sleep disorders, depression, and impaired hearing, vision, taste and smell, it said.