Article: FDA adds black box to Xolair.(Warnings/Recalls)(Brief article)

Article: FDA adds black box warning for ...
Internal Medicine News;  April 1, 2005 ;     700+ words ... ... Food and Drug Administration is adding a black box warning to the health professional labels ... intolerant of, first-line therapies. Black Box Alternatives Before voting for a black box warning, the panel debated several prescriber ...

Article: FDA Adds 'Black Box' Warning to ...
PR Newswire;  October 25, 2006 ;     700+ words ... ... deadly bleeding. The dangers for these events have not escaped FDA notice, and serious "Black Box" warning on Coumadin was recently mandated. The "Black Box" warns of "major or fatal bleeding," and notes that "Bleeding is more likely to occur ...

Article: FDA adds black box warning for ...
Drug Topics;  January 21, 2002 ;     285 words ...The FDA and Bristol-Myers Squibb have added a black box warning and strengthened the warnings, contraindications, and precautions sections in the labeling for Serzone (nefazodone HCl ...

Article: FDA Adds Black Box to Anemia Drugs
AP Online;  March 7, 2008 ;     700+ words ...Drug maker Amgen Inc. says regulators have added new warnings about risks of death and tumor growth to its blockbuster anemia drugs. The new warnings approved Friday by the Food and Drug Administration warn that the company's drugs increased death and accelerated tumor growth in patients with

Article: FDA adds heart attack risk to label of diabetes ...
Bucks County Courier Times;  November 15, 2007 ;     700+ words ... ... the FDA described the controversy in a black box on Avandia's label -- the most severe ... pending further research. Unlike most black-box warnings that urge strong caution, Avandia ... important, if imprecise. "It is a black-box warning, and no matter what the language ...

Article: FDA adds potential heart attack risk to label of ...
AP Worldstream;  November 14, 2007 ;     700+ words ... ... the FDA described the controversy in a black box on Avandia's label _ the most severe ... pending further research. Unlike most black-box warnings that urge strong caution, Avandia ... is important, if imprecise. It is a black-box warning, and no matter what the language ...

Article: FDA adds suicide-risk warning to atomoxetine.(Rx)
Internal Medicine News;  November 1, 2005 ;     700+ words ... ... Eli Lilly & Co. to place a new black box warning on atomoxetine (Strattera ... Straterra Global Advisory Board, said the black box warning is more severe than is warranted ... The signal is very weak, and the black box is very scary," she said. David Fassler ...