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FDA approves label changes for doripenem

The FDA today announced changes to the doripenum drug label to describe an increased risk for death and lower clinical cure rates compared with use of imipenem and cilastatin for injection, according to a press release.

Doripenum (Doribax, Janssen) is an antibacterial drug for the treatment of adult patients who developed pneumonia while on ventilators.

A 3-year clinical trial was stopped prematurely in 2011 due to these safety concerns.

“Doribax is still considered safe and effective for its FDA-approved indications — treatment of adults with complicated intra-abdominal infections and complicated urinary tract infections, including kidney infections called pyelonephritis,” FDA said.