Skip to content
    Font Size

    New C. diff Drug OK'd by FDA Panel

    New Antibiotic Effective, May Lower Risk of C. diff Recurrence
    WebMD Health News
    Reviewed by Laura J. Martin, MD

    April 5, 2011 – The FDA should approve Optimer's fidaxomicin for the treatment of the C. diff superbug, an expert advisory panel today unanimously agreed.

    C. diff (Clostridium difficile) infects as many as 3 million Americans every year, making it the top bacterial cause of severe diarrhea in the nation. Only one other drug, vancomycin, is FDA approved for treating the difficult-to-eradicate bug.

    Although metronidazole is often used as an "off-label" C. diff treatment, it often fails. "Off-label" refers to the practice of prescribing drugs for a purpose not specifically approved by the FDA. Fidaxomicin is designed to attack only C. diff, and may have less harmful effects on helpful gut bacteria.

    While the panel voted 13-0 in favor of approving fidaxomicin, it split in a 6-6 vote, with one abstention, over whether the FDA should let Optimer claim that the drug prevents C. diff recurrence.

    Recurrence is one of the worst things about C. diff. Even after successful treatment, up to 20% to 30% of patients see their C. diff infections come back. Many of these patients have recurrent attacks over the course of months or even years.

    Recurrence usually happens within 60 days of the initial treatment. Optimer's clinical trials showed that fidaxomicin cut recurrences over 31 days.

    The panel vote -- and the desperate need for new C. diff treatments -- makes rapid FDA approval appear likely. But the FDA and Optimer will have to wrangle about the exact claims that can be made about how well the drug prevents C. diff recurrence.

    Today on WebMD

    man holding his stomach
    Get the facts on common problems.
    blueberries in a palm
    Best and worst foods.
    woman shopping
    Learn what foods to avoid.
    fresh and dried plums
    Will it help constipation?
    diverticuliltis illustration
    couple eating at cafe
    sick child
    Woman blowing bubble gum

    Send yourself a link to download the app.

    Loading ...

    Please wait...

    This feature is temporarily unavailable. Please try again later.


    Now check your email account on your mobile phone to download your new app.

    Woman with crohns in pain
    Woman with stomach pain
    diet for diverticulitis
    what causes diarrhea