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FDA Drug Safety Podcast: FDA approves label changes for antibacterial Doribax (doripenem) describing increased risk of death for ventilator patients with pneumonia

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Welcome to the FDA Drug Safety Podcasts for healthcare professionals from the Division of Drug Information.  On March 6, 2014, the FDA issued a statement concluding that Doribax (generic name doripenem), an antibacterial drug that has been used to treat patients who develop pneumonia while on ventilators, carries an increased risk of death and lower clinical cure rates compared to imipenem and cilastatin for injection (brand name Primaxin).  Based on our analysis of data from a three-year clinical trial that was prematurely stopped in 2011 due to these safety concerns, the FDA approved changes to the Doribax drug label that describe these risks.

Doribax is not approved to treat any type of pneumonia. The revised label includes a new warning about this unapproved use.  Health care professionals should consider whether the benefits of Doribax treatment exceed its potential risks in patients who develop pneumonia while on ventilators.

Doribax is still considered safe and effective for its FDA-approved indications - treatment of complicated intra-abdominal infections and complicated urinary tract infections, including kidney infections or pyelonephritis.

In the clinical trial that was stopped early, patients with ventilator-associated bacterial pneumonia received either 7-day Doribax treatment or 10-day Primaxin treatment. Mortality was higher, while clinical cure rates were lower in the Doribax group.

Thank you for listening. A link to the full communication can be foundat www.fda.gov/DrugSafetyCommunications. Please report side effects involving Doribax to FDA’s MedWatch program at www.fda.gov/medwatch.

If you have drug questions, you can reach us at druginfo@fda.hhs.gov. And follow us on Twitter @FDA_Drug_Info for up to the minute important drug information. Know the moment it happens.

 

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