Drug safety regulators for the European Union recently recommended that Lemtrada use be restricted to certain limited patient populations due to serious side effects linked to Lemtrada. This November 5, 2019 Multiple Sclerosis News Today report, “EMA Safety Group Advises Lemtrada Be Limited to ‘Highly Active’ RRMS Patients at Hospitals … [Read more...]
Warnings About Significant Liver Injury Added To Tecfidera Drug Label
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...]
Risk of Hepatitis B Reactivation Associated With Gleevec And Iclusig
Currently available medicines in the BCR-ABL TKIs class of drugs include Gleevec and Iclusig, as well as Tasigna, Bosulif, and Sprycel. These BCR-ABL tyrosine kinase inhibitors (TKIs) are used for the treatment of specific types of blood cancers, including Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) and Ph+ acute … [Read more...]
Black-Box Warning For Harvoni, Sovaldi, Viekira Pak: Hepatitis B Risk
Direct-acting antivirals (DAAs) are a class of prescription medicines that are FDA-approved to treat adults with hepatitis C virus (HCV) infection. These medicines are available as single-ingredient products and also in combination with other HCV medicines. Here is a list of direct-acting antivirals currently available in the US: Daklinza … [Read more...]