September 27, 2013 — Tygacil (tigecycline) will carry a “Black Box Warning” about an increased risk of death compared to other antibiotics, according to a Drug Safety Communication published today by the U.S. Food and Drug Administration (FDA).
The changes were based on an analysis that showed 2.5% of Tygacil patients died, compared to 1.8% of patients receiving other antibiotics. The cause of death was unknown, but generally resulted from worsening infections, complications of infection, or other underlying medical conditions.
The FDA previously warned about evidence linking Tygacil and death in September 2010 based on 13 trials involving over 7,000 patients. Since then, they have analyzed additional data from 10 clinical trials involving over 5,000 patients.
According to the FDA:
“The increased risk was greatest in patients treated with Tygacil for ventilator-associated pneumonia, a use for which FDA has not approved the drug. … Health care professionals should reserve Tygacil for use in situations when alternative treatments are not suitable.”
The new warnings come about one year after Public Citizen, a consumer advocacy group, called on the FDA to add a “Black Box” to warn about the increased risk of death from Tygacil.
Tygacil (tigecycline) in an injectable antibiotic drug that has been sold by Pfizer since 2005. It is approved to treat complicated skin and skin-structure infections, complicated intra-abdominal infections, and community-acquired pneumonia. FDA also reminded physicians that Tygacil is not approved to treat diabetic foot infection, hospital-acquired pneumonia, or ventilator-associated pneumonia.
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