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FDA: Doribax no longer approved for treating pneumonia

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The FDA no longer approves the use of doripenem for treatment among patients who develop pneumonia while on ventilators, according to an FDA MedWatch alert.

The agency concluded that doripenem (Doribax, Shionogi Inc.) lowers clinical cure rates and increases patients’ risk for death, after results from a 3-year clinical trial that compared the antibacterial drug with the use of imipenem/cilastatin for injection (Primaxin, Merck).

The trial was prematurely stopped in 2011 due to safety concerns. The results show the all-cause mortality rate was higher in those who received doripenem (23%) vs. imipenem/cilastatin (16.7%). Clinical cure rates also were lower in the doripenem group.

The FDA revised the doripenem drug label to include a warning about its unapproved use for all types of pneumonia.

“Health care professionals should consider whether the benefits of Doribax treatment are likely to exceed potential risks in patients who develop pneumonia while on ventilators. 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,” the FDA said in the MedWatch alert.