Safety Updates to the Arava™ Labeling

Rare cases of pancytopenia, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in patients receiving Arava (leflunomide). Revised prescribing information now states the Arava is not recommended for patients with severe immunodeficiency, bone marrow dysplasia, or sever, uncontrolled infections. If evidence of bone marrow suppression, Steven-Johnson syndrome or toxic epidermal necrolysis occurs, treatment with Arava should be stopped and a drug elimination procedure is recommended.

In most cases of reported pancytopenia, patients were receiving concomitant treatment with methotrexate, other immunosuppressive agents, or had recently discontinued these therapies. In some cases, patients had a prior history of a significant hematological abnormality. For more information about updated prescribing information, call Aventis Pharmaceuticals at 1-800-633-1610.

Editorial Comment (Joan Bathon, M.D.): Since leflunomide and methotrexate both have the capacity to lower blood counts, it makes common sense NOT to use these drugs in patients with pre-existing bone marrow problems. The skin reactions appear to be idiosyncratic.