Skip to main content

ZINBRYTA to face restrictions on use, following a safety review by EMA showing serious liver damage

Multiple sclerosis (MS) is condition in which the immune system attacks myelin sheath, which may eventually damage the neurons and leave scar tissue, relapsing multiple sclerosis is a type of sclerosis in which there is flare up following remission, which means during the relapsing phase, the symptoms of MS will partially or completely go away. 

daclizumab is a type of Interleukin 2 receptor (IL2R) antagonist which is used in the treatment of MS. (Interleukin is a type of Cytokine which binds with IL2R to generate immune responses, a type cell signalling) daclizumab was administered as an injection under brand ZINBRYTA, which was first approved by FDA on 27th May 2016, however recently the Pharmacovigilance Risk Assessment committee (PRAC), a part of European Medical Agency recommended restrictions on using daclizumab, due to safety issues associated with serious liver damage (as reported in a clinical trial where 1.7 % subjects developed serious liver reaction, a suspected unexpected serious adverse reaction (SUSAR) when administered with daclizumab).

We at Think I are committed to provide robust pharmacovigilance solutions. We use cloud based technology which are not only cost effective and user friendly but also fully validated for quick, easy import, entry and electronic submissions of adverse event. 

For more details, contact us at +91 9560102587, +91 9810068241 or email us at medical@thinki.in  or simply visit www.thinki.in

Comments

  1. This comment has been removed by a blog administrator.

    ReplyDelete

Post a Comment

Popular posts from this blog

What is a ‘backward forward convertor’ ?

Did you know that ICH has a backward forward conversion (BFC) tool which was build using eXtensible Stylesheet Language Transformation (XSLTs) ? This language basically transforms a XML file of a given format into another XML file of a different format. The BFC tool requires a program that understands XSLT language to make conversion of E2B (R2) to E2B (R3) and vice versa. Now considering this, the European medical agency has improvised the BFC tool with additional fields as per the EU implementation guide. The EU version of the amended BFC tool has been published on the EMA website. The key files in the BFC package includes downgrade-icsr.xsl; which downgrades E2B (R3) file into E2B (R2) and upgrade-icsr.xsl; which upgrades E2B (R2) file into an E2B (R3) file. The acknowledgement convertors include downgrade-ack.xsl and upgrade-ack.xsl What are the technical limitations of BFC tools? However, the conversion using BFC has some major limitations. When converting I

MHRA’s Black Triangle Report

In United Kingdom, there are certain drugs in which although they were granted marketing approval by the Medicines and healthcare product regulatory agency (MHRA), they need to be closely monitored, since limited information were available about these drugs.  One of the key reasons attributed to this may be, less subjects being enrolled in the clinical trials, short therapy duration etc.…thus, in order to identify rare adverse reactions, effect of the drug in different populations or effect of the drug under different co-morbidities, such drugs are tagged with an inverted black triangle ( ▼ ) on their package insert, to ensure that these drugs are intensively monitored. The Commission on Human Medicines (CHM) and MHRA encourages expedited reporting within 15 calendar days of all such drugs with an inverted black triangle symbol if, found to have caused serious or non-serious adverse drug reaction. You may find the black triangle drugs at the Electronic

Chat Bot- the first artificial intelligence bot in Pharmacovigilance

Merck Sharp & Dohme (MSD) Corp., a subsidiary of Merck & Co., Inc has developed an Artificial Intelligence (AI) chat bot. The MSD Salute chat bot is designed to aid physicians in providing product information and pathology.  The Physicians who are registered with MSD would use the Chat bot using facebook messenger.  Chat bot is derived from the social media and uses machine learning and implements feedback to develop interactions.  Currently MSD is monitoring and not filtering the communication between Chat bot and users, as they want to analyse the open ended exchanges between the AI and the users. Chat bot currently in the testing phase, is said augment patient safety through proactive pharmacovigilance .  We at Think I are also driven to produce Pharmacovigilance safety database solutions using cloud based technology which are not only cost effective and user friendly but also fully validated for quick, easy import, entry and electronic submissions of adve