A new boxed warning about this risk will be added to the tigecycline drug label and included in the Warnings and Precautions and the Adverse Reactions sections of the label. A boxed warning is the strongest warning given to a drug.
The FDA approved Tigecycline in 2005 to treat complicated skin infections and intra-abdominal infections and in 2009 to treat community-acquired pneumonia.“It’s troubling that the agency took so long to require a black box warning on the drug label for this antibiotic, particularly since data demonstrating the increased mortality risk with the drug had been known to the agency since at least 2010,” said Michael Carome, director, Public Citizen’s Health Research Group.
In 2010, the FDA issued a safety alert to health care professionals informing them of the increased mortality rate associated with the use of intravenous tigecycline compared to that of other antibiotics, said Carome.
“The agency said then that alternatives to tigecycline should be considered in patients with serious infections,” he said. “The FDA also required in 2010 that the drug label be modified to include data about the increased mortality risk, but this information was not placed prominently in a black box warning, and it failed to describe appropriate restrictions on use of the drug.”
Public Citizen requested the addition of a black box warning
to tigecycline in an October
2011 citizen petition to the FDA.
Given the about 30 percent higher rate of mortality in subjects receiving tigecycline as well the significantly higher rates of failures to cure serious infections, the failure of the FDA to require a black box warning years ago is inexcusable, Carome said.