Federal drug safety regulators are changing the labeling on the antibiotic Tygacil to indicate that it carries an increased risk of death when compared to other antibiotics.
The FDA issued a Tygacil safety alert and notification of label change on September 1 after an analysis of 13 different clinical trials showed that the mortality rate with Tygacil was higher when treating all types of infections, but particularly when treating ventilator-associated pneumonia. Patients given Tygacil to treat pneumonia had a 20% chance of dying, compared to only 12% from competing antibiotics.
The FDA recommended healthcare professionals consider alternatives to Tygacil when treating patients with severe infections.
Tygacil (tigecycline) was approved by FDA for the treatment of certain types of infections in June 2005. Created by Wyeth, which is now owned by Pfizer, Inc., the drug is approved to treat complicated skin infections, intra-abdominal infections, and community-acquired pneumonia. It is not approved for the treatment of hospital-acquired pneumonia (including ventilator-associated pneumonia).
The FDA analysis of 13 different trials found that, overall, the risk of death when Tygacil was used to treat an infection was 4%, compared to a risk of 3% when other antibiotics were used. But in certain areas, the risk spiked, including ventilator-assisted pneumonia, and when used to treat hospital-acquired pneumonia of all kinds and resistant pathogens. The FDA points out that in many cases the increased risk is not statistically significant. However, the fact that it has a higher death rate in all categories and spikes in a few specific ones, led FDA to issue the warning.
Hospital-acquired pneumonia is a common risk for critically ill patients, particularly those on ventilators. Contraction of pneumonia puts critically ill patients at a 20 to 30 percent risk of death, and can increase a patient’s hospital stay by seven to nine days, potentially exposing them to other complications. Pneumonia usually occurs because stomach secretions have entered the lungs.