Tygacil, an Intravenous Antibacterial, Poses Higher Mortality Risk

The FDA informed healthcare professionals that the intravenous antibacterial Tygacil (tigecycline) poses a higher mortality risk compared to other drugs used to treat serious infections in a similar manner.

The increased risk was found when clinical trials were analyzed. The exact cause of the deaths was often uncertain, though it was believed to be due to the severe infections worsening. The higher risk of death was most evident, but not limited to, patients treated for pneumonia acquired in the hospital. Other incidents of increased risk include patients treated for skin, diabetic foot and intra-abdominal infections.

Although Tygacil is approved by the FDA for treating community acquired pneumonia, skin structure and complicated skin infections and complicated intra-abdominal infections it is not FDA approved for treating diabetic foot infection or hospital-acquired pneumonia.

The FDA notified healthcare professionals of these high risks through a Dear Health Care Professional letter. They also updated the Adverse Reactions and Warnings and Precautions sections on the Tygacil label.