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FDA Requires Black Box Warning for IV Antibacterial Tygacil® After Analyses Confirm Higher Risk of Death

On September 27, 2013, the FDA sent a Drug Safety Announcement warning that “an additional analysis shows an increased risk of death when intravenous (IV) Tygacil® (tigecycline) is used for FDA-approved uses as well as non-approved uses.” The FDA also required a Black Box Warning to be added to the Tygacil® label to inform doctors and consumers of the increased risk of death associated with use of the drug. The FDA added that a Black Box Warning is the strongest type of warning given to any drug.

In September 2010, the FDA issued a similar Drug Safety Announcement regarding the increased risk of death associated with Tygacil®. The Drug Safety Communication was sent based on the fact that a meta-analysis of 13 Phase 3 and 4 trials concluded that patients receiving Tygacil® have an increased risk of death in comparison to patients receiving other antibacterial drugs. In particular, death occurred in 4% of the patients receiving Tygacil®, in comparison to 3% of the patients receiving other antibacterial drugs. The increased risk of death was highest in patients treated with Tygacil® for ventilator-associated pneumonia – a use that is not FDA approved.

The FDA provided that their basis for the new Black Box Warning was based on additional analyses performed after the issuance of the September 2010 Drug Safety Announcement. In particular, the FDA analyzed data from 10 clinical trials conducted only for FDA-approved uses of Tygacil®, which included trials conducted after the approval of Tygacil. The FDA concluded that the data demonstrated an increased risk of death among patients receiving Tygacil® in comparison to patients receiving other antibacterial drugs. Specifically, death occurred in 2.5% of patients receiving Tygacil®, in comparison to 1.8% of patients receiving other antibacterial drugs.

The FDA warns that “[h]ealth 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, complicated intra-abdominal infections, and community-acquired bacterial pneumonia. Tygacil® is not indicated for treatment of diabetic foot infection or for hospital-acquired or ventilator-associated pneumonia.”

The new Black Box Warning contained within the updated Tygacil® label provides as follows: “All-cause mortality was higher in patients treated with TYGACIL® than comparators in a meta-analysis of clinical trials. The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established. TYGACIL® should be reserved for use in situations when alternative treatments are not suitable…” The updated Tygacil® label is available here.

 

 

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