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FDA Mandates Black Box Warning for Some Antibiotics
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Page: << Prev | 1 | 2 | 3 Fluoroquinolones are drugs approved for the treatment or prevention of certain bacterial infections. Like other antibacterial drugs, fluoroquinolones don't treat viral infections such as colds or the flu.
After Tuesday's announcement, Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, said the black box warning accomplishes two of the three steps that Public Citizen has urged the FDA to take for nearly two years.
But, he added in a news release, "The FDA is silent on our request that it also send a warning letter to physicians clearly describing possible adverse reactions, such as tendon pain, so that patients can be switched to alternative treatments before tendons rupture."
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More information
For more on antibiotics, visit the U.S. National Library of Medicine.
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Copyright © 2008 ScoutNews, LLC. All rights reserved.
Last updated 7/8/2008
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SOURCES: July 8, 2008, teleconference with Edward Cox, M.D., director, Office of Antimicrobial Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Renata Albrecht, M.D., director, Division of Special Pathogen and Transplant Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; July 8, 2008, news release, Public Citizen, Washington, D.C.
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