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Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of any other drug and may not reflect the rates observed in practice.
The safety of DIFICID 200 mg tablets taken twice a day for 10 days was evaluated in 564 patients with CDAD in two active-comparator controlled trials with 86.7% of patients receiving a full course of treatment.
Thirty-three patients receiving DIFICID (5.9%) withdrew from trials as a result of adverse reactions (AR). The types of AR resulting in withdrawal from the study varied considerably. Vomiting was the primary adverse reaction leading to discontinuation of dosing; this occurred at an incidence of 0.5% in both the fidaxomicin and vancomycin patients in Phase 3 studies.
Table 1: Selected Adverse Reactions with an Incidence
of ≥ 2% Reported in DIFICID Patients in Controlled Trials
|DIFICID (N=564)||Vancomycin (N=583)|
|System Organ Class Preferred Term||n (%)||n (%)|
|Blood and Lymphatic System Disorders|
|Anemia||14 (2%)||12 (2%)|
|Neutropenia||14 (2%)||6 (1%)|
|Nausea||62 (11%)||66 (11%)|
|Vomiting||41 (7%)||37 (6%)|
|Abdominal Pain||33 (6%)||23 (4%)|
|Gastrointestinal Hemorrhage||20 (4%)||12 (2%)|
The following adverse reactions were reported in < 2% of patients taking DIFICID tablets in controlled trials:
Metabolism and Nutrition Disorders: hyperglycemia, metabolic acidosis
Skin and Subcutaneous Tissue Disorders: drug eruption, pruritus, rash
Post Marketing Experience
Adverse reactions reported in the post marketing setting arise from a population of unknown size and are voluntary in nature. As such, reliability in estimating their frequency or in establishing a causal relationship to drug exposure is not always possible.
Read the Dificid (fidaxomicin tablets for oral administration) Side Effects Center for a complete guide to possible side effects
Fidaxomicin and its main metabolite, OP-1118, are substrates of the efflux transporter, P-glycoprotein (P-gp), which is expressed in the gastrointestinal tract.
Cyclosporine is an inhibitor of multiple transporters, including P-gp. When cyclosporine was co-administered with DIFICID, plasma concentrations of fidaxomicin and OP-1118 were significantly increased but remained in the ng/mL range [see CLINICAL PHARMACOLOGY]. Concentrations of fidaxomicin and OP-1118 may also be decreased at the site of action (i.e., gastrointestinal tract) via P-gp inhibition; however, concomitant P-gp inhibitor use had no attributable effect on safety or treatment outcome of fidaxomicin-treated patients in controlled clinical trials. Based on these results, fidaxomicin may be co-administered with P-gp inhibitors and no dose adjustment is recommended.
Last reviewed on RxList: 4/18/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Dificid Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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