FDA Approves New Drug to Treat C. diff

June 1, 2011 -- The FDA has approved the use of an antibacterial drug called Dificid to treat adult patients with an infectious type of diarrhea that has become a significant problem in hospitals and long-term care facilities.

Dificid (fidaxomicin) comes in tablet form and is specifically targeted at Clostridium difficile, also known as C. difficile, C. diff, and CDAD.

C. diff is found in the stool of infected patients, and the FDA says other people can become infected by touching items or surfaces that have been contaminated with the germ and then touching their mouths.

C. Diff on the Rise

"In recent years, many in the infectious disease community have seen an increase in the number of cases of people with C. difficile infection," Edward Cox, MD, MPH, of the FDA, says in a news release. "Dificid is an effective new treatment option for patients who develop Clostridium difficile-associated diarrhea."

Dificid should be taken orally two times a day for 10 days, with or without food, the FDA says. The drug is the first antibiotic in nearly 30 years to be approved to fight the sometimes deadly C. diff-caused disease.

According to the CDC, C. diff sickens about half a million people a year in the U.S. To maintain its effectiveness and reduce development of drug-resistant bacteria, Dificid should be used only to treat infections that are either proved or strongly suspected to be caused by C. diff.

Dificid Side Effects

Optimer Pharmaceuticals, the maker of Dificid, says the most common side effects of the drug are nausea, vomiting, abdominal pain, gastrointestinal hemorrhage, anemia, and low white blood cell count. 

"The incidence and severity of CDAD has increased dramatically in the U.S. in the past decade and is continuing to rise each year," Sherwood Gorbach, MD, the company's chief scientific officer, says in a news release. "Dificid is an important new first-line treatment option for patients who may be most at risk of disease recurrence, for whom producing a sustained clinical response is critical."

"CDAD is a serious illness that can be incredibly disruptive to patients' lives, sometimes causing as many as 20 or more episodes of diarrhea a day which in certain patients can result in significant dehydration," Kathleen Mullane, DO, of the University of Chicago, says in the news release.

Cost of Treating C. Diff

The news release says medical treatment and hospital stays associated with C. diff cost the U.S. health care system as much as $3.8 billion a year. Also, the company says a recent survey of the incidence and severity of C. diff in U.S. hospitals found that C. diff patients had lengths of hospital stay nearly three times longer than average, with mortality rates more than four times higher than for the average person who is hospitalized.

The FDA says the safety and efficacy of Dificid were shown in two trials that included 564 patients with C. diff that compared effectiveness of the drug with patients taking vancomycin, an antibiotic.

In the trials, more patients treated with Dificid were considered cured after three weeks of treatment, compared with people taking vancomycin, the FDA says.