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Fluoroquinolone-Induced Tendinopathy: What Do We Know? continued...
[South Med J 92(6):622-625, 1999. © 1999 Southern Medical Association]
IncidenceFluoroquinolones are antibacterial agents with an exceptional record of accomplishment regarding safety and efficacy. Generally, they are well tolerated with a minimum of side effects. During clinical trials of ciprofloxacin, the drug was discontinued in only 3.5% of patients tested. The most frequently reported events were nausea (5.2%), diarrhea (2.3%), vomiting (2.0%), abdominal pain/discomfort (1.7%), headache (1.2%), restlessness (1.1%), and rash (1.1%). Adverse events considered likely to be drug related occurred in 7.3% of patients treated and possibly related in 9.2%.[2] Tendinopathy related to fluoroquinolone treatment has been reported but is an infrequent occurrence compared with the incidence of arthralgia and myalgia. Although the exact incidence is not known, some authors have estimated the incidence of fluoroquinolone-induced tendinopathy to be 15 to 20/100,000 treated patients.[3,4] However, to date, there are no prospective studies that will allow direct calculation of the relative risk of tendinopathy in patients treated with fluoroquinolones. Fluoroquinolones were first associated with Achilles' tendinitis in 1983.[5] The first case of tendon rupture by ciprofloxacin was reported to the Committee on Safety of Medicines in 1987.[6] Although there were 84 reported cases of fluoroquinolone-associated tendinitis or tendon rupture by 1995, the FDA did not issue a Report of Adverse Events until October 1996.[7,8] There are more than 200 reported cases of fluoroquinolone associated tendinitis, mostly in European medical journals and many associated with pefloxacin (not marketed in the United States). Tendinitis by other agents such as ofloxacin, norfloxacin, enoxacin, lomefloxacin, and ciprofloxacin has been reported, but incidence appears to be much lower. From 1987 to July 1997, the FDA had received 201 reported cases of tendon disorders associated with fluoroquinolones. This did not include the foreign cases associated with pefloxacin. The breakdown by event, drug, and location (United States or foreign) are listed in Table 1.
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