NeLM news service
Public Citizen calls on FDA to add black box warning to US tigecycline label

Source: BioSpace

Date published: 01/11/2011 16:32

Summary
by: Nicola Pocock

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.]

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