Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA requests boxed warning on gadolinium agents, prompts criticism

This article was originally published in Clinica

Executive Summary

All US FDA-approved gadolinium-based MRI contrast agents (GBMCAs) are to feature a boxed warning on their labelling at the agency's request, to caution physicians about the potential adverse effects of such agents in severe kidney disease patients. The move has prompted mixed reactions from observers. Chairman of the American College of Cardiology (ACR) blue ribbon panel on MR safety, Emanuel Kanal, feels that the FDA's warning request "omits important facts", regarding the higher prevalence of certain agents, notably GE's Omniscan, in causing the debilitating and potentially fatal disease nephrogenic systemic fibrosis (NSF). GBMCAs have now been implicated in over 200 cases of NSF.

You may also be interested in...



What Lies Ahead: COVID-19 Vaccination Challenges

The director of adult immunizations at Johns Hopkins International Vaccine Access Center talks to Scrip about undertaking a massive COVID-19 vaccination effort in the US.

P&G: Sales Growth Strongest When Rising Tide Floats All Competitors Across All Categories

P&G’s oral care business drove 35% of total category market growth in the firm’s fiscal 2020 and exemplifies its growth strategy for all segments – grow entire categories rather than take competitors’ market share, says CFO Jon Moeller.

COVID-19 Vaccine 'Brexit Bonus' A Myth

The Pink Sheet explains the procedures underpinning the UK’s emergency use authorization of the Pfizer/BioNTech COVID-19 vaccine.

Topics

UsernamePublicRestriction

Register

OM006664

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel