June 6, 2012 — The consumer watchdog group Public Citizen has updated its petition to add a “Black Box” warning on the label of the antibiotic Tygacil. The group wants warnings that clearly state the drug has an increased risk of death. The updated petition includes the results from a new study, which adds to the growing amount of scientific evidence linking Tygacil to a higher mortality rate than other antibiotics.
Public Citizen sent its first petition to the FDA back in October of 2011. Since then, more scientific evidence has emerged linking Tygacil to an increased risk of death compared to other antibiotics. Public Citizen decided to update their petition to include the new risk information.
The updated petition will include data from a clinical trial which found Tygacil associated with a 0.7% increased risk of death, and a 2.9% increased risk of non-cure rates, when compared with other antibiotics. According to Public Citizen, this translates to one extra death per 143 patients, and one extra non-cure per 34 patients who get Tygacil instead of another antibiotic.
Public Citizen is warning that there are other antibiotic treatments that are equally effective but have a lower risk of mortality. Therefore, Tygacil should only be used as an antibiotic of last resort when other antibiotics have failed to cure the infection.
According to Public Citizen, the life-threatening side effects of Tygacil should be highlighted in a Black Box, which is the strongest warning that the FDA can place on a drug. The group is also calling for manufacturers to issue a “Dear Doctor” letter, which is a standard way of informing physicians about the risks associated with certain drugs.
Tygacil (tigecycline) is a new antibiotic, which was developed in 2005 by Wyeth, which is now a part of Pfizer, Inc. The FDA has approved Tygacil to treat complex skin infections, abdominal infections, and community-acquired pneumonia.
In 2011, the FDA issued a safety announcement to warn that Tygacil is associated with a higher risk of death. The increased risk was seen for all infections, but was highest when physicians used Tygacil off-label for treating ventilator-associated pneumonia — 20% of these patients who were given Tygacil died, compared with 12% of patients given other antibiotics.