Nerve damage associated with Arava

[Guest guest]

Clin Pharmacol Ther. 2004 Jun;75(6):580-5.

Peripheral neuropathy in patients treated with leflunomide.

Bonnel RA, Graham DJ.

Office of Drug Safety, Center for Drug Evaluation and Research, US Food

and Drug Administration, Rockville, MD 20857, USA. bonnelr@...

OBJECTIVE: Our objective was to describe the clinical features, time

course, and outcome of new-onset peripheral neuropathy occurring in

patients treated with leflunomide. METHODS: Case reports of peripheral

neuropathy submitted to the US Food and Drug Administration in

association with leflunomide use were reviewed. Data on patient

demographics, underlying medical conditions and medications, details of

leflunomide therapy, and treatment and outcome of the neuropathy event

were abstracted. Time to neuropathy onset and time to improvement or

recovery were analyzed by survival analysis. RESULTS: Of 80 reported

patients, 61% were women. The patients' mean age was 62 years. Symptoms

of peripheral neuropathy began after a mean of 6 months of leflunomide

use (range, 3 days to 3 years). Electrodiagnostic testing in 37 patients

was consistent with a distal axonal, sensory, or sensorimotor

polyneuropathy in most patients. Patients who stopped leflunomide use

within 30 days of neuropathy symptom onset were more likely to have

improvement or recovery than those who continued taking leflunomide for

a longer period (P <.001).

CONCLUSION: Leflunomide use is associated with peripheral neuropathy in

some patients. This neuropathy is usually axonal in nature, affecting

multiple sensory or motor nerves of distal extremities. Patients who

stopped leflunomide use within 30 days of symptom onset were more likely

to have improvement of symptoms or complete recovery than were patients

who continued to use the drug for longer periods of time.

PMID: 15179412

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org