FDA NEWS RELEASE
For Immediate Release: May 27, 2011
Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA approves treatment for Clostridium difficile infection
The U.S. Food and Drug Administration today approved Dificid (fidaxomicin)
tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD).
Clostridium difficile (C. difficile) is a bacterium that can cause diarrhea
and lead to colitis, other serious intestinal conditions, and death in severe
cases. C. difficile bacteria are found in the stool of an infected person, and
others can become infected if they touch items or surfaces contaminated with
the bacteria or spores and then touch their mouths.
The safety and efficacy of Dificid were demonstrated in two trials that
included 564 patients with CDAD that compared Dificid with vancomycin, a common
antibiotic used to treat CDAD. The clinical response was similar in the Dificid
group compared with the vancomycin group in both studies. In some patients with
CDAD, symptoms can return. In the Dificid trials, a greater number of patients
treated with Dificid had a sustained cure three weeks after treatment ended
versus those patients treated with vancomycin.
"In recent years, many in the infectious disease community have seen an
increase in the number of cases of people with a C. difficile infection," said
Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in
the FDA's Center for Drug Evaluation and Research. "Dificid is an effective new
treatment option for patients who develop Clostridium difficile-associated
diarrhea."
Dificid, a macrolide antibacterial, should be taken two times a day for 10
days with or without food.
To maintain the effectiveness of Dificid, and to reduce the development of
drug-resistant bacteria, the drug should be used only to treat infections that
are proven or strongly suspected to be caused by C. difficile.
The most common side effects reported with Dificid included nausea, vomiting,
headache, abdominal pain, and diarrhea.
People at risk of developing the bacterial infection include the elderly,
patients in hospitals or nursing homes, and people taking antibiotics for
another infection. The most effective way to prevent CDAD is thorough
handwashing with soap and warm water.
Dificid was developed by San Diego-based Optimer Pharmaceuticals Inc.
For more information:
CDC: Prevent Clostridium difficile Infection1
Approved Drugs: Questions and Answers2
The FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and security
of human and veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the safety and
security of our nation's food supply, cosmetics, dietary supplements, products
that give off electronic radiation, and for regulating tobacco products.
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(END) Dow Jones Newswires
05-27-11 1519ET
15:19 052711
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