| Subject: | FDA Announces New Safety Information for All Gadolinium-Based Contrast Agents |
| Category: | Food and Drug Administration (FDA)
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| Published: | Wed, 23 May 2007 - 03:00 pm |
| The FDA has asked manufacturers to include a new-boxed warning on the product labeling of all gadolinium-based contrast agents (GBCAs) used to enhance the quality of magnetic resonance imaging (MRI).The new prescribing information that the FDA is requesting would highlight and describe the risk for nephrogenic systemic fibrosis (NSF) following exposure to a GBCA in patients with:Acute or chronic severe renal insufficiency (glomerular filtration rate less than 30 mL/min/1.73 square meters) Acute... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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