The Food and Drug Administration said Friday Tygacil, or tigecycline, should only be used in situations when other treatments aren't suitable. The intravenous drug is approved as a treatment for complicated skin and skin structure infections and community-acquired bacterial pneumonia. The FDA will add a boxed warning to the drug label, its most serious type of warning.
In 2010 the FDA said Tygacil was associated with a greater risk of death than other antibacterial drugs. It says a new analysis confirmed that conclusion. The risk was greatest in patients with ventilator-associated pneumonia. Tygacil hasn't been approved for that condition.
The agency said it's not clear why the drug is associated with a higher risk of death compared to other drugs.
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