According to BioSpace, US advocacy group Public Citizen has sent a petition to the US FDA calling on the agency to place a black box warning on tigecycline (Tygacil®) warning of a higher mortality rate associated with the use of this drug compared with other widely used antibiotics, and stating that it should only be used as a last resort in the treatment of serious infections, in combination with one or more bactericidal antibiotics. The petition can be viewed at the link below.
[Editor’s note: Following a safety review, the CHMP recently restricted the use of tigecycline within the EU – please see the links below for details. Tigecycline should only be used within its licensed indications (complicated skin and soft tissue infections and complicated intra-abdominal infections) and only when it is known or suspected that other drugs are unsuitable.]