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Increased Risk of Death with IV Antibacterial Tygacil (Tigecycline)


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?

 

 

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