Dificid (fidaxomicin) has been approved by the FDA for CDAD (Clostridium difficile-Associated diarrhea). Clostridium Difficile, also known as C. difficile, a bacterium, causes diarrhea in humans, which can eventually lead to colitis and some serious intestinal complications. In severe cases the patient can die.

Contamination usually comes from an infected person who does not wash his/her hands after going to the toilet and then touches other people or surfaces, thus spreading the infection.

The FDA (Food and Drug Administration) evaluated safety and efficacy studies involving 564 individuals with CDAD. The studies compared Dificid with the antibiotic vancomycin, which is commonly used when treating CDAD. In both studies, both drugs had similar responses. However, more patients on Dificid had a sustained cure three weeks after treatment compared to those on vancomycin.

Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said:

"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. Dificid is an effective new treatment option for patients who develop Clostridium difficile-associated diarrhea."

CDAD patients take Dificid twice daily for ten days. It is a macrolide antibacterial, as are Azithromycin, Clarithromycin, Dirithromycin, Erythromycin, Roxithromycin, and Telithromycin.

The FDA stresses that Dificid should only be used in proven or strongly suspected infections caused by C. difficile, otherwise its effectiveness might be undermined. It is also important to prevent drug-resistant bacteria from developing.

Dificid side effects included abdominal pain, diarrhea, headache, nausea and vomiting.

Elderly individuals, as well as hospital and nursing home patients, along with people on antibiotics for other infections are at risk of developing bacterial infection.

The best way to prevent CDAD is to wash your hands properly with soap and warm water.

Dicifid was developed and is marketed by Optimer Pharmaceuticals Inc, of San Diego, California.

Source: FDA

Written by Christian Nordqvist