Friday, September 03, 2010

Tygacil FDA warning

Uh Oh.

The U.S. Food and Drug Administration (FDA) is reminding healthcare professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline) compared to that of other drugs used to treat a variety of serious infections. The increased risk was determined using a pooled analysis of clinical trials. The cause of the excess death in these trials is often uncertain, but it is likely that most deaths in patients with these severe infections were related to progression of the infection.

The increased risk was seen most clearly in patients treated for hospital-acquired pneumonia, especially ventilator-associated pneumonia, but was also seen in patients with complicated skin and skin structure infections, complicated intra-abdominal infections and diabetic foot infections. Tygacil is not approved for the treatment of hospital-acquired pneumonia (including ventilator-associated pneumonia) or diabetic foot infection. Tygacil is approved by FDA for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community acquired pneumonia...

Data Summary
The pooled analysis grouped 13 trials with patients given Tygacil for both approved and unapproved indications by type of infection (see Table below), comparing the overall mortality for Tygacil vs. pooled control agents. Overall, in the trials, death occurred in 4.0% (150/3788) of patients receiving Tygacil and 3.0% (110/3646) of patients receiving comparator antibiotics. An adjusted risk difference for all-cause mortality based on a random effects model stratified by trial weight was 0.6% (95% CI 0.1, 1.2) between Tygacil and comparator treated patients.
The differences weren't statistically significant for individual infection types but for the combined data the difference was statistically significant. The reasons for this trend are not clear. Medscape commentary here.

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