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moxifloxacin (AVELOX)

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    Statement of Sidney Wolfe, M.D., Director of the Health Research Group at Public Citizen
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    Despite long-standing evidence that fluoroquinolone antibiotics can cause tendon ruptures, the Food and Drug Administration (FDA) has failed to increase its warnings to patients and physicians about the dangers of the medicines, Public Citizen told a federal court Thursday.
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    Public Citizen, representing more than 100,000 consumers nationwide, hereby petitions the Food and Drug Administration (FDA), pursuant to the Federal Food, Drug and Cosmetic Act 21 U.S.C. Section 355(e)(3), and 21 C.F.R. 10.30, to immediately add a black box warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics presently on the market in the United States.

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