The Food and Drug Administration (FDA) has issued a warning for Tygacil for a death risk if the intravenous drug is used for uses approved or not approved by the FDA.
The warning is found as a new “Boxed warning” on the drug which described a higher danger of death. The change was made due to further analysis done for FDA-approved uses of Tygacil following the FDA issuing a Drug Safety Communication regarding its concerns in September of 2010.
That analysis revealed a greater death risk among patients using Tygacil compared to alternative antibacterial drugs. Deaths occurred due to complications of infection, worsening of infections or underlying medical conditions.
Tygacil has been approved by the FDA to treat community-acquired bacterial pneumonia (CABP), complicated skin and skin structure infections (cSSSI) and complicated intra-abdominal infections (cIAI).
The FDA recommends that healthcare professionals should use Tygacil only when other treatments aren’t suitable as an alternative.
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