Nephrogenic systemic fibrosis and class labeling of gadolinium-based contrast agents by the Food and Drug Administration
| Autor: | Alex Gorovets, James Kaiser, Robert Boucher, Ira Krefting, Lucie Yang, Louis Marzella, Dwaine Rieves |
|---|---|
| Rok vydání: | 2012 |
| Předmět: |
Drug labeling
Pathology medicine.medical_specialty Class (computer programming) business.industry United States Food and Drug Administration Gadolinium chemistry.chemical_element Contrast Media medicine.disease Bioinformatics Magnetic Resonance Imaging United States Nephrogenic Fibrosing Dermopathy Food and drug administration Drug class chemistry Nephrogenic systemic fibrosis medicine Humans Radiology Nuclear Medicine and imaging business Drug Labeling |
| Zdroj: | Radiology. 265(1) |
| ISSN: | 1527-1315 |
| Popis: | In 2007, the Food and Drug Administration requested that manufacturers of all approved gadolinium-based contrast agents (GBCAs), drugs widely used in magnetic resonance imaging, use nearly identical text in their product labeling to describe the risk of nephrogenic systemic fibrosis (NSF). Accumulating information about NSF risks led to revision of the labeling text for all of these drugs in 2010. The present report summarizes the basis and purpose of this class-labeling approach and describes some of the related challenges, given the evolutionary nature of the NSF risk evidence. The class-labeling approach for presentation of product risk is designed to decrease the occurrence of NSF and to enhance the safe use of GBCAs in radiologic practice. |
| Databáze: | OpenAIRE |
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