Tygacil (tigecycline): Safety Communication on Increased Risk of Death


Infectious disease, critical care and pharmacy personnel are informed by the FDA about the new boxed warning added on the Tygacil prescribing information to warn about the increased risk of death.

Tygacil, tigecycline,

Background of Tygacil (tigecycline)

Tygacil (tigecycline) is used for the treatment of complicated skin and skin structure infections (cSSSI), complicated intra-abdominal infections (cIAI), and community-acquired bacterial pneumonia (CABP).

FDA Alert on Tygacil (tigecycline)

Additional analysis conducted by the FDA revealed a higher risk of death among patients receiving Tygacil versus other antibacterial drugs: 2.5% (66/2640) vs. 1.8% (48/2628), respectively at 95% confidence interval. The deaths resulted from worsening infections, complications of infection, or other underlying medical conditions.

FDA Recommendation on Tygacil (tigecycline)

“Health care professionals should reserve Tygacil for use in situations when alternative treatments are not suitable.”

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