An Inexcusable Delay: FDA Finally Approves Black Box Warning for Antibiotic Tygacil, as Called for by Public Citizen

Statement of Michael Carome, Director, Public Citizen’s Health Research Group

September 27, 2013

Contact: Angela Bradbery (202) 588-7741; Sam Jewler (202) 588-7779

Public Citizen welcomes today’s announcement by the U.S. Food and Drug Administration that the agency finally has approved a new black box warning for the antibiotic tigecycline, also known as Tygacil. The new warning indicates that data from clinical trials showed that tigecycline has an increased risk of death in comparison to other antibiotics and therefore should be reserved for use in situations when alternative treatments are not suitable.

The addition of such a black box warning to tigecycline — a drug that was approved by the FDA in 2005 to treat complicated skin infections and intra-abdominal infections and in 2009 to treat community-acquired pneumonia — was the primary action requested by Public Citizen in aOctober 2011 citizen petition to the FDA.

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. Indeed, 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. The agency said then that alternatives to tigecycline should be considered in patients with serious infections. 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.

Given the approximately 30 percent higher rate of mortality in subjects receiving tigecycline in comparison to other antibiotics, as well the significantly higher rates of failures to cure serious infections, in comparison to subjects treated with comparator antibiotics, the failure of the FDA to require a black box warning years ago is inexcusable.

In its 2011 petition, Public Citizen also had called on the FDA to include a statement in a black box warning for tigecycline advising that it should be used only in combination with one or more bactericidal antibiotics (antibiotics that directly kill bacteria, rather than interfere with bacteria growth). Unfortunately, the FDA did not require this additional statement in the new black box warning announced today.