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tigecycline (TYGACIL)

Additional Information from Public Citizen

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  • [hide all summaries]
    Public Citizen welcomes the announcement by the Food and Drug Administration (FDA) that the agency has approved a new black box warning for the antibiotic tigecycline (brand name: Tygacil). The warning indicates that clinical trials have found an increased risk of death with tigecycline in comparison to other antibiotics and that the drug should thus be used only when alternative treatments are not suitable. Public Citizen first requested this warning in a November 2011 citizen petition to the FDA.
  • [hide all summaries]
    Public Citizen submitted additional data supporting its October 2011 petition to the FDA to immediately require the addition of a black box warning to the label for tigecycline (Tygacil) indicating that the antibiotic: a) has an increased risk of death in comparison to many other antibiotics when used to treat a variety of serious infections; and b) should be used only as a last-resort antibiotic in the treatment of serious infections, and then only in combination with one or more bactericidal antibiotics.
  • [hide all summaries]
    Public Citizen petitions the Food and Drug Administration to immediately require the addition of a black box warning to the label for tigecycline (Tygacil) indicating that the antibiotic: a) has an increased risk of death in comparison to many other antibiotics when used to treat a variety of serious infections; and b) should be used only as a last-resort antibiotic in the treatment of serious infections, and then only in combination with one or more bactericidal antibiotics.

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