Imagine if you will that your loved one was prescribed a simple antibiotic to treat their pneumonia, and then the worst thing happens, he/she dies. But, the coroner’s office doesn’t rule the cause of death due to the pneumonia, they claim it’s because of the antibiotic they were being treated with. As crazy as this whole scenario sounds, it is unfortunately true.
According to Reuters, drug maker Johnson & Johnson has shut down their clinical trial of its antibiotic Doribax after patients taking the drug had higher rates of death and a lower cure rate than those who got an alternative medicine, U.S. health regulators said on January 5, 2012.
Although in the United States, the antibiotic is currently approved to treat adults with complicated urinary tract or abdominal infections, this trial was attempting to use the antibiotic to treat pneumonia, the Food and Drug Administration said.
Doribax is manufactured by Japanese drugmaker Shionogi & Co., known generically as doripenem, and is approved for hospital-acquired pneumonia in Europe. Doripenem is in the class of carbapenem antibiotics. The clinical trial was conducted as part of a post-marketing requirement from the European Medicines Agency, said Shaun Mickus, spokesman at Janssen, the J&J unit that markets the drug.
The recommended dose of Doribax—for adults—is 500 mg every eight hours intravenously, with the dose administered over one hour and for between five and 14 days, depending on indication.
In June 2007, Johnson & Johnson applied for U.S. approval of Doribax for the treatment of pneumonia acquired in the hospital, known as nosocomial pneumonia, which includes ventilator-associated pneumonia.
The FDA asked the company for more information in August 2008, and Mickus said the company had resubmitted its application and was still in discussions with the agency.
In the halted clinical trial, researchers tested Doribax on 274 patients with ventilator-associated pneumonia, and those who received the drug had a 6.7 percent higher rate of death from any cause than patients getting an alternative.
Patients taking Doribax also had a 11.2 percent lower rate of being cured than patients getting imipenem-cilastatin, the generic version of Merck & Co Inc’s Primaxin.
Mickus said the trial had study sites in several countries, including the United States.
The trial was halted in May 2011 based on the recommendation of an independent data monitoring committee, and the company finished analyzing the results recently.
In the halted trial, the 28-day all cause mortality rate was 21.5 percent for those who received Doribax compared with 14.8 percent in the control group.
“The bottom line is Doribax is safe and effective when used according to its approved label,” Mickus told Businessweek in a telephone interview.
The FDA will communicate any new information on Doribax and this clinical trial when it becomes available.