US FDA should require Black Box warning for Pfizer's antibiotic Tygacil, says Public Citizen

US advocacy group Public Citizen has sent a petition to the Food and Drug Administration calling on the agency to place a black box warning on an antibiotic used to treat a wide range of infections because of a higher mortality rate associated with taking the drug than other widely used antibiotics, Public Citizen said in a petition sent today to the agency.

The antibiotic, drug giant Pfizer’s (NYSE: PFE) 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 Pharma Letter September 6, 2010). 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. Critical safety information does not appear in a black box warning at the top of the label and fails to describe appropriate restrictions on the use of the drug.