Arnold Lentnek.

Study Population Patients were enrolled at 52 sites in the usa and 15 sites in Canada. Eligible patients were 16 years of age or older with a analysis of C. Difficile infection, defined by the presence of diarrhea and C. Difficile toxin A, B, or both in a stool specimen obtained within 48 hours before randomization. Patients could have received up to four doses of metronidazole or vancomycin in the 24 hour-period before randomization and no other potentially effective concurrent remedies for C. Difficile illness . Patients with life-threatening or fulminant C. Difficile infection, toxic megacolon, previous contact with fidaxomicin, a history of ulcerative colitis or Crohn’s disease, or even more than one occurrence of C. Difficile infection within three months before the start of the scholarly study were excluded.As the Society is happy with this announcement, we understand the shortage continues to be essential at many sites throughout the country and urge the FDA to make sure that once supplies are available, hematologists can have information on how to gain access to this therapy because of their critically ill individuals. ASH has been working hard to address the shortage, including reporting shortages to the FDA and Congress and urging the FDA to take immediate action to identify other manufacturers to meet up demand, import supplies from abroad, and establish a crisis supply once there is a release in order that supplies can be conveniently accessed.

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