Aventis Arava Adds Physical Function Claim, Bolded Liver Safety Warning
Executive Summary
Arava labeling has been updated to include more explicit liver function monitoring directions
You may also be interested in...
FDA Looked To Arava’s Safety Experience In Gauging Aubagio’s Risks
Agency’s assessment of teriflunomide for multiple sclerosis incorporated the known safety data for leflunomide, a chemically related drug with an extensive post-marketing record in rheumatoid arthritis. Despite hepatotoxicity and other safety concerns with the older drug, its clinical experience provided reassurance that Aubagio’s risks could be managed without a REMS.
FDA Upgrades Warnings On Four Of Seven Drugs Flagged In Vioxx Testimony
An upgrade to Abbott's Meridia riskmanagement program means FDA has taken action to strengthen warnings on four of seven drugs flagged by FDA Office of Drug Safety Associate Director David Graham, MD, during the Senate Finance Committee's hearing on Vioxx
FDA Upgrades Warnings On Four Of Seven Drugs Flagged In Vioxx Testimony
An upgrade to Abbott's Meridia riskmanagement program means FDA has taken action to strengthen warnings on four of seven drugs flagged by FDA Office of Drug Safety Associate Director David Graham, MD, during the Senate Finance Committee's hearing on Vioxx