Supplement to Petition to FDA for Tigecycline Black Box Warning
May 15, 2012
Public Citizen submitted additional data supporting its October 2011 petition to 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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Petition Requesting Black Box Warning on Tigecycline (Tygacil), October 26, 2011