Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Clinical Trial Experience
- addition of hyperhidrosis to the table
- injection site reactions and cases of pseudo-relapses erythema multiforme and Stevens-Johnson syndrome
- suicide and hepatic injury
- reports of thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, retinal vascular disorders, and convulsive disorders.
- systemic lupus erythematosus, autoimmune hepatitis, and pancytopenia
What is the most important information....
- added ..... injection site problems
Pregnancy Category C
- There are no adequate and well-controlled studies in pregnant women. Rebif should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus…