Adverse drug reactions with fluoroquinolones.

The French system of drug surveillance has analysed the notifications of adverse drug reactions (ADRs) to fluoroquinolones since they were launched. Their frequency ranges from 1/15,000 to 1/208,000 case per days of treatment. Cutaneous diseases and tendon disorders predominate in France whereas cutaneous effects and neuropsychiatric disorders are predominant in the UK; tendon disorders take up only the 5th position. Among the most unexpected ADRs are the following: -shock represents 33 of the anaphylaxis reactions which range from 1/5.6 x 10(6) to 1/4.4 x 10(5) case per days of treatment. -acute renal failure is rare: one case/80,000 patients treated by ciprofloxacin to 1/320,000 by norfloxacin. The pathophysiology is not well known. Tendon ruptures represent 81 cases for 921 notifications of tendon disorders which are related in decreasing order to pefloxacin 1/23,130 case per days of treatment, ofloxacin, norfloxacin and ciprofloxacin 1/779,600 case per days of treatment. Age and corticosteroids increase the risk of tendon rupture.