Public Citizen has sent a petition to the FDA urging the agency to place a “black box” warning on Pfizer’s Tygacil because of a higher mortality rate associated with taking the drug than other widely used antibiotics.
Tygacil (tigecycline) was approved by the FDA in 2005 to treat complicated skin infections and intra-abdominal infections and in 2009 to treat community-acquired pneumonia. However, last year, the FDA issued a safety alert to health care professionals informing them of an increased mortality rate associated with the use of intravenous tigecycline compared to that of other antibiotics.
The agency said that alternatives to tigecycline should be considered in patients with serious infections. At the same time, the FDA required that the drug label be modified to include data about the increased mortality risk, but these warnings were inadequate, Public Citizen said in the petition.
The watchdog group called on the FDA to add a black box warning to the antibiotic’s label indicating the increased risk of death and advising that it should be used only as a last-resort antibiotic, and then only in combination with one or more bactericidal. Public Citizen also petitioned the agency to require an FDA-approved medication guide to be distributed to patients, as well as a “Dear Doctor” letter to physicians, warning them of the dangers of the drug and the need for restricted use.