The safety profile of
leflunomide in the treatment of
rheumatoid arthritis has been well documented in clinical trials, postmarketing surveillance, and epidemiological studies. Both postmarketing surveillance and epidemiological study results are consistent with the safety profile of
leflunomide reported in clinical trials, and no increased risk was observed with
leflunomide, compared with other
disease modifying antirheumatic drugs; these studies have allowed a more precise representation of the incidence of adverse events occurring with
leflunomide under normal conditions of care. The most common
leflunomide-associated adverse events include
diarrhea, elevated liver
enzymes,
alopecia, and
rash. Ninety-five percent of the Expert Panel considered the adverse events associated with
leflunomide to be manageable. If an adverse event required treatment to be stopped, many of the experts would consider subsequently restarting
leflunomide. For minor adverse events, it was suggested that the physician might also consider using
cholestyramine or
charcoal to determine if the side effect is dose-related and, if it was, reduce the
leflunomide dose accordingly. In addition to informing patients about the likelihood of side effects, it is important to emphasize that their incidence appears to diminish with continued treatment. It is also important to adequately support patients who are experiencing side effects and involve them in their disease management, for example, by offering the choice of reducing the
leflunomide dose and/or having symptomatic treatment. Other patient management recommendations in this review reflect the views of the majority of participants as expressed in the meeting.