The Pharmaceutical Journal Vol 267 No 7172 p633-638
3 November 2001

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Anthrax threat prompts announcement of fluoroquinolone adverse events

Ciprofloxacin and other fluoroquinolone antibiotics could be associated with severe and permanently disabling adverse peripheral nervous system effects, says Dr Jay Cohen, associate professor of family and preventive medicine, University of California, San Diego. These effects can occur following just one or two doses, he says.

Dr Cohen conducted a survey of cases of fluoroquinolone-associated adverse events that included peripheral nervous system (PNS) symptoms reported on internet websites. His paper, due to be published in the December issue of The Annals of Pharmacology has been posted on the journal's website (www.theannals.com) because of the current threat of anthrax infection and the interest in ciprofloxacin as an effective treatment (PJ, 20 October, p537 and 27 October, p590).

Dr Cohen analysed 45 cases (including 11 involving ciprofloxacin) that met standards of the United States Food and Drug Administration MedWatch programme. He found that 36 cases were severe with chronic pain and/or limited normal function. Symptoms, which included tingling, numbness and spasms, were typically long-term with 27 per cent of cases lasting longer than two years. Dr Cohen says that onset of adverse events was usually rapid. Most cases (n=26, 58 per cent) began within 72 hours of starting fluoroquinolone therapy. Some patients reported that their doctor discontinued antibiotic therapy promptly when symptoms occurred but 18 patients said that their doctor either failed to recognise, or dismissed the significance of, their neuropathies. Four patients reported being told to continue taking the antibiotic despite complaining of adverse events.

Dr Cohen concludes: "The benefits of [ciprofloxacin] and other fluoroquinolones must be weighed carefully and treatment must be undertaken judiciously. There are anecdotal reports of people [in the US] taking ciprofloxacin prophylactically. Health care providers need to be vigilant regarding ADEs associated with fluoroquinolones, and even mild events involving the nervous or musculoskeletal systems should prompt immediate discontinuation."

A spokeswoman for Bayer, manufacturer of Ciproxin, told The Journal that the study was lacking in detail. She pointed out that it did not address the fact that peripheral tingling, one of the suspected adverse reactions mentioned in the study, was known to be a symptom in some urinary tract infections.

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