"Significant Safety Concern": Higher Death Rate For Doribax In Ventilator-Associated Pneumonia When Compared To Patients Receiving Imipenem Therapy
The product monograph for Doribax will be updated to reflect findings from a study showing a higher mortality rate and a lower cure rate among patients taking Doribax 1g every 8 hours in a fixed 7-day course as compared to those taking a fixed 10-day course of imipenem-cilastatin....
On January 5, 2012 the FDA issued a drug safety alert about the antibiotic Doribax, from the Janssen division of Johnson & Johnson (J&J), that that provided us this information:
The U.S. Food and Drug Administration (FDA) is informing the public that a recent clinical trial with Doribax (doripenem) was stopped early because of significant safety concerns. This trial, which was evaluating the effects of Doribax on treatment of patients with ventilator-associated pneumonia, demonstrated excess mortality and a numerically poorer clinical cure rate among subjects treated with Doribax compared to those treated with imipenem-cilastatin. FDA is reviewing the trial results and will communicate any new information that results from this investigation.
This January 2012 FDA Statement also said that Janssen is issuing a so-called "Dear Doctor" letter about this Doribax - pneumonia clinical trial.
Doribax is approved for urinary and abdominal infections in the U.S. but not for any type of pneumonia. However, in Europe Doribax use is approved for ventilator-associated pneumonia and the stopped study was being conducted to fulfill a post-marketing commitment from Janssen / J&J to the European Medicines Agency (EMA).
We learned from this January 6, 2012 Dow Jones Newswire article, "Trial Of J&J Antibiotic Stopped Early On Safety Concerns", that, in fact, there had been a seven-month delay between the time when the Doribax - pneumonia clinical trial was stopped and when the FDA issued its January 2012 safety alert:
After 28 days from the start of treatment, 21.5% of patients who received Doribax had died, compared with 14.8% of patients in the imipenem group, according to the FDA. Also, Doribax was associated with lower cure rates than the imipenem group, the FDA said....
J&J spokesman Shaun Mickus said the company terminated the trial in May 2011 based on the recommendation of an independent data monitoring committee.
Mickus said J&J notified the FDA, global health regulators and study investigators promptly in May 2011 about the interim findings. The company had additional discussions in the ensuing months, and a more complete data analysis was only recently completed, Mickus said.
We also learned from that same Dow Jones article, by reporter Peter Loftus:
J&J, New Brunswick, N.J., previously applied for FDA approval to market Doribax for treatment of hospital-acquired pneumonia, including ventilator-associated pneumonia, but the FDA has declined to approve the application.
We are not currently aware of when the EMA first alerted the public in Europe about this emerging safety issue concerning Doribax nor whether any regulatory action has been undertaken by the EMA to withdraw its previous approval for Doribax use in patients with ventilator-associated pneumonia.
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