FDA issues new Boxed Warning on Pfizer antibacterial
The US Food and Drug Administration is warning that an additional analysis shows an increased risk of death when US pharma behemoth Pfizer’s (NYSE: PFE) intravenous (IV) antibacterial Tygacil (tigecycline) is used for FDA-approved uses as well as for non-approved uses.
As a result, the agency approved a new Boxed Warning about this risk to be added to the Tygacil drug label and updated the Warnings and Precautions and the Adverse Reactions sections. A Boxed Warning is the strongest warning given to a drug. These changes to the Tygacil label are based on an additional analysis that was conducted for FDA-approved uses after issuing a Drug Safety Communication (DSC) about this concern in September 2010.
Tygacil was approved in the USA in 2005. The drug generated sales of $335 million in 2012, of which $152 million came from the USA.
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