The Food and Drug Administration (FDA) is ordering the intravenous antibiotic Tygacyl (tigecycline) include on its safety label a new black box warning for increased risk of death compared to other antibacterial drugs.
Tygacyl was given a fast-track approval by the FDA in 2005. The drug was developed in response to the growing prevalence of antibiotic resistance in bacteria such as Staphylococcus aureus and Acinetobacter baumannii. The drug was approved to treat complicated skin and soft tissue infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia.
Tygacil is not approved for the treatment of diabetic foot infection or for hospital-acquired or ventilator-associated pneumonia.
The FDA has ordered the new black box warning be placed on Tygacyl for both approved and unapproved uses after an additional analysis was conducted for FDA-approved uses following an FDA Drug Safety Communication about this safety concern in September 2010.
The new analysis involved data from 10 clinical trials conducted only for FDA-approved uses, including trials conducted after the drug was approved. Researchers found a higher risk of death among patients receiving Tygacil compared to other antibacterial drugs. Patients at greatest risk of death were given Tygacil for the treatment of ventilator-associated pneumonia, which is an unapproved use.
In general, the deaths resulted from worsening infections, complications of infections, or other underlying medical conditions.
The FDA advises health care providers to only use Tygacil in situations when alternative treatments are not suitable. Patients and caregivers with questions should contact their doctors.