FDA requests boxed warning on gadolinium agents, prompts criticism
This article was originally published in Clinica
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...
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’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.
The Pink Sheet explains the procedures underpinning the UK’s emergency use authorization of the Pfizer/BioNTech COVID-19 vaccine.