Skip to Main Content
TABLE 1

Rate of FDA-Defined Arthropathy 6 Weeks and 1 Year After Treatment With Ciprofloxacin or a Comparator

Ciprofloxacin (n = 335) Comparator (n = 349)
Arthropathy rate at 6-week follow-up,an (%) 31 (9.3) 21 (6.0%) 
 95% CI, % (–0.8 to 7.2) 
Cumulative arthropathy rate at 1-year follow-up,an (%) 46 (13.7) 33 (9.5%) 
 95% CI, % (–0.6 to 9.1) 
Selected musculoskeletal adverse eventsb in patients with arthropathy at 1-year follow-up  Ciprofloxacin n = 46 patientsc Comparator n = 33 patientsc 
 Arthralgia 35 (76) 20 (61) 
 Abnormal joint and/or gait examination 11 (24) 8 (24) 
 Accidental injury 6 (13) 1 (3) 
 Leg pain 5 (11) 1 (3) 
 Back pain 4 (9) 
 Arthrosis 4 (9) 1 (3) 
 Bone pain 3 (7) 
 Joint disorder 2 (4) 
 Pain 2 (4) 2 (6) 
 Myalgia 1 (2) 4 (12) 
 Arm pain 2 (6) 
 Movement disorder 1 (2) 1 (3) 
Ciprofloxacin (n = 335) Comparator (n = 349)
Arthropathy rate at 6-week follow-up,an (%) 31 (9.3) 21 (6.0%) 
 95% CI, % (–0.8 to 7.2) 
Cumulative arthropathy rate at 1-year follow-up,an (%) 46 (13.7) 33 (9.5%) 
 95% CI, % (–0.6 to 9.1) 
Selected musculoskeletal adverse eventsb in patients with arthropathy at 1-year follow-up  Ciprofloxacin n = 46 patientsc Comparator n = 33 patientsc 
 Arthralgia 35 (76) 20 (61) 
 Abnormal joint and/or gait examination 11 (24) 8 (24) 
 Accidental injury 6 (13) 1 (3) 
 Leg pain 5 (11) 1 (3) 
 Back pain 4 (9) 
 Arthrosis 4 (9) 1 (3) 
 Bone pain 3 (7) 
 Joint disorder 2 (4) 
 Pain 2 (4) 2 (6) 
 Myalgia 1 (2) 4 (12) 
 Arm pain 2 (6) 
 Movement disorder 1 (2) 1 (3) 

Data are from ref 8. CI, confidence interval.

a

The study was designed to show that the arthropathy rate for the ciprofloxacin group did not exceed that of the comparator group by more than +6.0%. At both evaluations, the 95% CI indicated that it could not be concluded that ciprofloxacin had findings comparable to the comparator.

b

Events occurring in 2 or more patients.

c

A patient with arthropathy may have had more than 1 event.

Close Modal

or Create an Account

Close Modal
Close Modal