In January 2017 liver injury was added to the Warnings and Precautions part of the Prescribing Information document, or drug label, for Tecfidera (dimethyl fumarate), which was approved by the FDA in 2013 as a treatment of patients with relapsing forms of multiple sclerosis (MS). We get background information and some commentary from this … [Read more...]
Leukemia Drug Iclusig Had More Safety Warnings Added In November 2016
Here is overview of this rather significant and substantial November 2016 Iclusig Prescribing Information revision which was mandated by the FDA. In the Boxed Warning section of the Iclusig drug label there was some additional safety information put in the pre-existing parts about (1) various types of arterial occlusions and (2) heart failure. … [Read more...]