Leflunomide Labeling Revised to Reflect Risk.

Nov. 21, 2007 — Aventis Pharmaceuticals has updated the prescribing accusal for leflunomide (Arava), indicated for the direction of voice rheumatoid arthritis, to reflect findings of hepatic unhealthiness, according to an warning from MedWatch, the U.S.
Food and Drug Establishment (FDA) refuge message and adverse consequence reporting performance.

In postmarketing occurrent worldwide, rare, serious hepatic hurt, including cases with fatal finish, have been reported during communicating with leflunomide.
Most cases occurred within six months of therapy and in a place of multiple risk factors for hepatotoxicity.

Rare postmarketing reports of severe infections, including sepsis, which may be fatal, were also received.
Most of the reports were confounded by concomitant immunosuppressant therapy and/or comorbid illness, which, in plus to rheumatoid disease, may predispose patients to corruptness.

In the company’s letter of the alphabet to healthcare professionals, Aventis describes the changes to leflunomide’s mark, which includes counsel “regarding continuance of the initial monthly internal organ enzyme monitoring, intervals for monitoring in the livelihood of attention, and dose discontinuation for confirmed ALT elevations more than 3 meter reading the bunk terminus ad quem of normal.”

Additional warnings have been added to the “immunosuppression potential/bone gist suppression” segment “to emphasize that disruption of therapy with Arava may be necessary if a serious unhealthiness occurs while on Arava.”

This is a part of article Leflunomide Labeling Revised to Reflect Risk. Taken from "Arava Information" Information Blog