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【bio-news】FDA要求钆基造影剂包装盒添加警告标签
http://www.medscape.com/viewarticle/557190
Yael Waknine
May 24, 2007 — Healthcare professionals have been notified of a US Food and Drug Administration (FDA) request for the addition of warnings (including a boxed warning) to the safety labeling for gadolinium-based contrast agents (GBCAs) used to enhance the quality of magnetic resonance imaging, the agency announced yesterday.
The revisions are intended to highlight the risk for nephrogenic systemic fibrosis (NSF; also known as nephrogenic fibrosing dermopathy [NFD]) after GBCA exposure in certain patient populations, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program.
These include patients with acute or chronic severe renal insufficiency (defined as glomerular filtration rate [GFR] < 30 mL/min/1.73 m2), acute renal insufficiency due to hepatorenal syndrome, and those in the perioperative hepatic transplantation period. Use of GBCA in these settings should be avoided unless information of essential importance is not available by alternate means.
The FDA has previous warned healthcare professionals regarding cases of NSF after single and multiple administration of GBCAs. Although the cases were not limited to any particular agent, gadodiamide (Omniscan; GE Healthcare) was most frequently implicated, followed by gadopentetate dimeglumine (Magnevist; Bayer Schering Pharma), and gadoversetamide (OptiMARK; Mallinckrodt, Inc).
NSF also has been reported in connection with sequential administration of gadodiamide and gadobenate dimeglumine or gadoteridol (MultiHance and ProHance; Bracco Diagnostics, Inc).The FDA notes that because exposure is inadequately described in these reports, it remains unclear whether the risk is similar for all 5 approved GBCAs.
Healthcare professionals are reminded to screen patients for renal problems prior to use of these imaging agents. Also, dose recommendations should not be exceeded and enough time should be given to allow product clearance prior to its reuse.
Patients at risk for NSF should be closely observed after gadolinium exposure and instructed to contact a healthcare professionals regarding potential symptoms such as skin burning, itching, reddened/darkened patches and/or inflammation, hardening, and/or tightening; yellow raised spots on the sclera; joint stiffness; limited range of peripheral movement; deep hip/rib pain; and/or muscle weakness.
Although there is no known treatment for the condition, improved renal function (spontaneous or via renal transplantation) appears to slow or arrest its development and may even yield a gradual reversal of the condition.
Healthcare professionals are encouraged to report cases of NSF potentially associated with exposure to gadolinium-containing contrast agents to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领 FDA Requests Boxed Warning for Gadolinium-Based Contrast Agents
FDA要求钆基造影剂包装盒添加警告标签
http://www.medscape.com/viewarticle/557190
Yael Waknine
May 24, 2007 — Healthcare professionals have been notified of a US Food and Drug Administration (FDA) request for the addition of warnings (including a boxed warning) to the safety labeling for gadolinium-based contrast agents (GBCAs) used to enhance the quality of magnetic resonance imaging, the agency announced yesterday.
2007年5月24日－美国食品药品监督管理局昨天宣布提醒私人保健医生注意钆基造影剂安全标签的警告（包括包装盒上的警告），钆基造影剂可以增强磁共振成像的质量。
The revisions are intended to highlight the risk for nephrogenic systemic fibrosis (NSF; also known as nephrogenic fibrosing dermopathy [NFD]) after GBCA exposure in certain patient populations, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program.
根据一个来自MedWatch（美国食品和药物管理局安全信息和不良反应的报告程序）的警报，这些修改建议意味着突出钆基造影剂对某些特定患者的肾源性系统纤维化（NSF；也可以称之为肾源性纤维性皮肤病[NFD]）的危险。
These include patients with acute or chronic severe renal insufficiency (defined as glomerular filtration rate [GFR] < 30 mL/min/1.73 m2), acute renal insufficiency due to hepatorenal syndrome, and those in the perioperative hepatic transplantation period.
这些包括一些病人患有急性或慢性重度肾功能不全（确诊标准肾小球滤过率[GFR]小于30ml/min/1.73m2），急性肾功能不全可存在于肝肾综合症和那些处于肝移植围手术期患者中。
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作者:admin@医学,生命科学 2011-02-25 17:11
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