The Food and Drug Administration (FDA) has issued the intravenous (IV) Tygacil (tigecycline) a Black Box Warning Label, the strongest warning given to a drug due to an increased risk of death. The safety concern originated in 2010, but the FDA recently added the warning label to the drug.
Tygacil is used to treat skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia.
Meta-analysis data showed an increased risk of death when Tygacil was used compared to other antibacterial drugs. The Heath Research Group stated “[Tygacil] should only be used as a last-resort antibiotic in the treatment of serious infections, and then only in combination with one or more bactericidal antibiotics.” The FDA warns that Tygacil should be used in situations where other safer alternative treatments are not suitable.
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