Public Citizen Urges FDA to Place a Black Box Warning on Tygacil

Consumer group Public Citizen has urged FDA to put a black box warning on the antibiotic Tygacil due to a higher mortality rate associated with the medication than with similar antibiotics. FDA approved Tygacil in 2005 for the treatment of skin and intra-abdominal infections. Tygacil was approved in 2009 for the treatment of pneumonia. Tygacil is manufactured by Pfizer, Inc. FDA mandated that the warning label be updated to specify the increased mortality risk, but Public Citizen considers this inadequate.