Doribax label changed because of increased death risk

March 11, 2014

Because the antibacterial drug Doribax (doripenem) has an increased risk of death and lower clinical cure rates than other drugs for pneumonia, FDA approved a new label for the medication.

Because the antibacterial drug Doribax (doripenem) has an increased risk of death and lower clinical cure rates than other drugs for pneumonia, FDA approved a new label for the medication.

“Based on our analysis of data from a three-year clinical trial that was prematurely stopped in 2011 due to these safety concerns, we have approved changes to the Doribax drug label that describe these risks,  FDA stated in a recent Safety Announcement.

FDA has been concerned about Doribax, used to treat patients who develop pneumonia while on ventilators, since 2012 when the clinical trial with Doribax was stopped early because of “significant safety concerns”.

FDA’s new analysis found that Doribax carries an increased risk of death and lower clinical cure rates compared to imipenem and cilastatin for injection (marketed in the United States under the name Primaxin).

 

“Doribax is not approved to treat any type of pneumonia, and the revised label also includes a new warning about this unapproved use,” FDA stated. “Healthcare professionals should consider whether the benefits of Doribax treatment are likely to exceed its potential risks in patients who develop pneumonia while on ventilators.”

In the clinical trial that was stopped early, patients with ventilator-associated bacterial pneumonia received either 7-day Doribax treatment or 10-day treatment with imipenem and cilastatin. In the intent-to-treat population, the 28-day all-cause mortality was higher in the Doribax arm (23.0%; n=31/135) than in the imipenem and cilastatin arm (16.7%; n=22/132). Clinical cure rates were also lower in the Doribax arm, FDA stated.

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

View the revised Doribax drug label at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022106s012lbl.pdf