The FDA warned that an additional analysis showed an increased risk of death when intravenous (IV) Tygacil (tigecycline) is used for FDA-approved uses as well as for non-approved uses. As a result, the FDA approved a new Boxed Warning about this risk to be added to the Tygacil drug label and updated the Warnings and Precautions and the Adverse Reactions sections. A Boxed Warning is the strongest warning given to a drug. These changes to the Tygacil label are based on an additional analysis that was conducted for FDA-approved uses after issuing a Drug Safety Communication about this safety concern in September 2010.
Health care professionals should reserve Tygacil for use in situations when alternative treatments are not suitable. Tygacil is FDA-approved to treat complicated skin and skin structure infections (cSSSI), complicated intra-abdominal infections (cIAI), and community-acquired bacterial pneumonia (CABP). Tygacil is not indicated for treatment of diabetic foot infection or for hospital-acquired or ventilator-associated pneumonia. Patients and their caregivers should talk with their health care professionals if they have any questions or concerns about Tygacil.
In a 2010 Drug Safety Communication, the FDA announced that a combined analysis, or meta-analysis, of thirteen Phase 3 and 4 trials showed a higher risk of death among patients receiving Tygacil compared to other antibacterial drugs: 4.0% vs 3.0%. The increased risk was greatest in patients treated with Tygacil for ventilator-associated pneumonia, a use for which FDA has not approved the drug.
Since issuing the 2010 Drug Safety Communication, the FDA analyzed data from ten clinical trials conducted only for FDA-approved uses (cSSSI, cIAI, CABP), including trials conducted after the drug was approved. This analysis showed a higher risk of death among patients receiving Tygacil compared to other antibacterial drugs: 2.5% (66/2640) vs. 1.8% (48/2628), respectively. In general, the deaths resulted from worsening infections, complications of infection, or other underlying medical conditions.
See the FDA Safety Announcement
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication
See also Medical Law Perspectives, March 2012 Report: Off-Label Use of Prescriptions: When is this Medical Malpractice? Is the Pharmaceutical Company Liable for Overpromotion?
See also Medical Law Perspectives, January 2012 Report: Hospital-Acquired Infections: Who Is Liable and Why?