Rheumatoid Arthritis Drug Linked to Nerve Problem

Some patients who take the anti-rheumatic drug Arava (leflunomide) develop peripheral neuropathy, a nerve problem that involves numbness, tingling or pain in the hands or feet.

Some patients who take the anti-rheumatic drug Arava (leflunomide) develop peripheral neuropathy, a nerve problem that involves numbness, tingling or pain in the hands or feet.However, the problem resolves when the drug is stopped, according to researchers from the US Food and Drug Administration.In the journal Clinical Pharmacology and Therapeutics, Drs. Renan A. Bonnel and. David J. Graham note that they reviewed 80 cases of peripheral neuropathy associated with Arava use.Peripheral neuropathy was not reported by any of the 816 Arava-treated patients in the clinical trials supporting the drug’s FDA approval, but as many as 4 percent of patients experienced sensory symptoms.In the current study, the onset of symptoms, including numbness, tingling or burning, severe pain, cold sensation in the extremities, or weakness, began from 3 to 1126 days after beginning Arava therapy.Age, sex, and daily dose of Arava were not associated with the time to onset of peripheral neuropathy or improvement or recovery from neuropathy. All patients were taking daily doses of Arava within the recommended range.Patients who stopped taking Arava within 30 days of neuropathy onset experienced improvement or recovered after around135 days, the researchers note. Patients who continued taking the drug for more than 30 days did not experience improvement or recovery unless they discontinued the drug.An FDA spokesperson told Reuters Health that the study did not attempt to “estimate how much of a risk there is, but it’s probably low.”Nevertheless, depending on many factors, including the severity of rheumatoid arthritis, “physicians and their patients may want to discuss whether to continue (Arava) if neuropathy symptoms develop.”(Source: Clinical Pharmacology and Therapeutics, Reuters, July 2004)