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New Warnings Issued on Use of Gadolinium-Based Contrast Agents

By MedImaging International staff writers
Posted on 04 Oct 2010
U.S. Officials are requiring that gadolinium-based contrast agents (GBCAs) carry new warnings on their labels about the risk of a rare and potentially fatal disorder known as nephrogenic systemic fibrosis (NSF), if the drug is administered to certain patients with kidney disease.

Three of the GBCAs--Magnevist, Omniscan, and Optimark--will be described as inappropriate for use among patients with acute kidney injury or chronic severe kidney disease. All GBCA labels will emphasize the need to screen patients to detect these types of kidney dysfunction before administration. GBCAs are intravenous drugs approved by the U.S. Food and Drug administration (FDA; Silver Spring, MD, USA) for use with magnetic resonance imaging (MRI) or MR angiography to help detect abnormalities of body organs, blood vessels, and other tissues.

NSF is a condition involving the formation of excess fibrous connective tissue in the skin, joints, eyes, and internal organs. Symptoms of NSF can include scaling, hardening, and tightening of the skin, red or dark patches on the skin, and stiffness. NSF may lead to death, especially if it involves body organs.

The FDA's review of the safety of the most widely used GBCAs determined that Magnevist, Omniscan, and Optimark are linked with a greater risk than other GBCAs for NSF in specific patients with kidney disease. Data suggest that NSF may follow the administration of any GBCA and the FDA continues to evaluate the safety of each GBCA to better estimate its NSF risks. "The FDA is requiring these labeling changes to enhance the safe use of gadolinium-based contrast agents, including avoidance of certain agents among patients at highest risk for nephrogenic systemic fibrosis,” said Rafel Rieves, M.D., director of the Division of Medical Imaging Products in the FDA's Center for Drug Evaluation and Research.

To further enhance the safe use of the imaging agents, the FDA recommends that health care professionals to estimate kidney function through laboratory testing for patients at risk for chronically reduced kidney function; to avoid use of GBCAs in patients suspected or known to have impaired drug elimination unless the imaging is essential and not available without contrast; to monitor for signs and symptoms of NSF if a GBCA is administered to a patient with acute kidney injury or chronic, severe kidney disease; and to administer a GBCA only once during an imaging session.

Magnevist is marketed by Bayer Healthcare (Leverkusen, Germany), Omniscan by GE Healthcare (Chalfont St. Giles, UK), and Optimark by Covidien (Mansfield, MA, USA).

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96 (26.941299438477): SELECT show_live FROM jos_com_show_setting LIMIT 1
97 (27.894973754883): SELECT show_live FROM jos_com_show_setting LIMIT 1
98 (26.941299438477): SELECT show_live FROM jos_com_show_setting LIMIT 1
99 (28.133392333984): SELECT show_live FROM jos_com_show_setting LIMIT 1
100 (26.941299438477): SELECT show_live FROM jos_com_show_setting LIMIT 1
101 (26.941299438477): SELECT show_live FROM jos_com_show_setting LIMIT 1
102 (26.941299438477): SELECT show_live FROM jos_com_show_setting LIMIT 1
103 (28.133392333984): SELECT show_live FROM jos_com_show_setting LIMIT 1
104 (97.990036010742): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294731404 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294731404 AND published='1' LIMIT 1
105 (51.021575927734): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294731404 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294731404 AND published='1' LIMIT 1
106 (58.889389038086): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294731404 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
107 (46.968460083008): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294731404 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
108 (102.99682617188): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294731404 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294731404 AND published='1' LIMIT 1
109 (55.074691772461): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294731404 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294731404 AND published='1' LIMIT 1
110 (48.87580871582): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=294731404 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
111 (560.99891662598): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=294731404 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
112 (607.96737670898): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1
113 (332.11708068848): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1
114 (87.02278137207): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294731404 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294731404 AND published='1' LIMIT 1
115 (45.061111450195): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294731404 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294731404 AND published='1' LIMIT 1
116 (57.93571472168): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294731404 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294731404 AND published='1' LIMIT 1
117 (40.054321289062): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294731404 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294731404 AND published='1' LIMIT 1
118 (64.849853515625): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294731404 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294731404 AND published='1' LIMIT 1
119 (49.829483032227): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294731404 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294731404 AND published='1' LIMIT 1
120 (114.20249938965): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294731404 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294731404 AND published='1' LIMIT 1
121 (56.028366088867): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294731404 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294731404 AND published='1' LIMIT 1
122 (335.9317779541): SELECT * FROM trending_articles WHERE `journal_id` = 10 AND `timestamp` <= NOW() + INTERVAL 7 DAY ORDER BY `order`
123 (!!!!! 19817.113876343): SELECT * FROM jos_deeppockets WHERE jos_deeppockets.cat = 10 AND jos_deeppockets.type = 'deeppockets_item' AND jos_deeppockets.published = 1 AND jos_deeppockets.created + INTERVAL 14 DAY >= NOW() ORDER BY jos_deeppockets.hits DESC LIMIT 7
124 (590.08598327637): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294731404 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294731404 AND type='deeppockets_item' AND published='1' LIMIT 1
125 (!!!!! 7416.9635772705): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3
126 (77.962875366211): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3
127 (39.100646972656): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803337 LIMIT 1
128 (38.862228393555): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803337 LIMIT 1
129 (68.187713623047): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803276 LIMIT 1
130 (32.901763916016): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803276 LIMIT 1
131 (281.09550476074): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets_archive AS dp WHERE dp.id = 294803276 LIMIT 1
132 (34.093856811523): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets_archive AS dp WHERE dp.id = 294803276 LIMIT 1
133 (29.802322387695): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294802958 LIMIT 1
134 (28.133392333984): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294802958 LIMIT 1
135 (341.17698669434): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294731404 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
136 (247.00164794922): SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294731404 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
137 (33.855438232422): SELECT name FROM jos_deeppockets WHERE id=212
138 (25.98762512207): SELECT name FROM jos_deeppockets WHERE id=212
139 (535.01129150391): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))212((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
140 (443.93539428711): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))212((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
141 (173.09188842773): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294731404 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294731404 AND published='1' LIMIT 1
142 (49.114227294922): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294731404 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294731404 AND published='1' LIMIT 1
143 (!!!!! 5434.0362548828): TRUNCATE TABLE jos_trademed_module
144 (167.8466796875): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294731404 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
145 (481.12869262695): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294731404 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
146 (589.84756469727): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294731404 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
147 (102.99682617188): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294731404 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
148 (478.98292541504): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294731404 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294731404 AND published='1' LIMIT 1
149 (!!!!! 3041.9826507568): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294731404 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294731404 AND published='1' LIMIT 1
150 (!!!!! 1688.0035400391): SELECT jos_item.* FROM jos_item INNER JOIN jos_number ON jos_item.numberID=jos_number.id WHERE 1=1 AND (jos_item.imgMini<>'') AND jos_item.type='L' AND jos_item.numberID= ( SELECT jos_number.id FROM jos_number WHERE jos_number.journalID IN (10) and jos_number.id in (select distinct jos_number.id from jos_number join jos_item on jos_item.numberid=jos_number.id where jos_item.type='P') ORDER BY (CONVERT(SUBSTRING(issue,1,2),SIGNED) + (CONVERT(SUBSTRING(issue,3,2),SIGNED)*100)) DESC LIMIT 0,1 ) ORDER BY RAND() DESC LIMIT 6
151 (375.03242492676): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294731404 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294731404 AND published='1' LIMIT 1
152 (51.975250244141): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294731404 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294731404 AND published='1' LIMIT 1
153 (286.81755065918): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294731404 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294731404 AND type='deeppockets_item' AND published='1' LIMIT 1
154 (40.054321289062): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=212 or channel_id is null)
155 (30.040740966797): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=212 or channel_id is null)
156 (267.02880859375): SELECT livesite FROM jos_dp_categories WHERE id=10 AND published='1' LIMIT 1
157 (265.12145996094): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294731404 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294731404 AND published='1' LIMIT 1
158 (49.114227294922): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294731404 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294731404 AND published='1' LIMIT 1
159 (256.06155395508): select jos_twitters.link from jos_twitters where cat=10
160 (36.001205444336): select jos_facebook.link from jos_facebook where cat=10
161 (121.11663818359): select jos_google_plus.link from jos_google_plus where cat=10
162 (30.994415283203): select jos_linkedin.link from jos_linkedin where cat=10
163 (467.77725219727): update jos_bannersmanager_banner set impmade=impmade+1 where id in(14615,14202,14203)
164 (!!!!! 1106.9774627686): insert into jos_banners_delta values (14615,'2025-06-27 19:57:04','216.73.216.249','view'),(14202,'2025-06-27 19:57:04','216.73.216.249','view'),(14203,'2025-06-27 19:57:04','216.73.216.249','view')