OVERVIEW

PRODUCT INFORMATION

CHEMICAL FORMULA AND STRUCTURE

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DRUG	CAS REGISTRY NO.	MOLECULAR FORMULA	STRUCTURE
Fidaxomicin	873857-62-6	C52-H74-Cl2-O18

ANNOTATED BIBLIOGRAPHY

References updated: 08 August 2017

• Moseley RH. Macrolide antibiotics. Hepatotoxicity of antimicrobials and antifungal agents. In, Kaplowitz N, DeLeve LD, eds. Drug-induced Liver Disease. 3rd ed. Amsterdam: Elsevier, 2013, pp. 466-7.

  (Expert review of macrolide antibiotic induced liver injury does not discuss fidaxomicin).
• MacDougall C, Chambers HF. Macrolides and ketolides. In, Brunton LL, Chabner BA, Knollman BC, eds. Goodman & Gilman’s the pharmacological basis of therapeutics. 12th ed. New York: McGraw-Hill, 2011, pp. 1529-34.

  (Textbook of pharmacology and therapeutics).
• Leitner JM, Graninger W, Thalhammer F. Hepatotoxicity of antibacterials: pathomechanisms and clinical data. Infection 2010; 38: 3-11. [PubMed: 20107858]

  (Review of antibiotic associated liver injury; the macrolide antibiotics may cause cholestatic hepatitis at an estimated rate of 3.6 per 100,000 prescriptions for erythromycin, 3.8 for clarithromycin, and 5.5 for telithromycin, compared to 10 for sulfonamides and 2000 per 100,000 for isoniazid; no mention of fidaxomicin).
• Reuben A, Koch DG, Lee WM; Acute Liver Failure Study Group. Drug-induced acute liver failure: results of a U.S. multicenter, prospective study. Hepatology 2010; 52: 2065-76. [PMC free article: PMC3992250] [PubMed: 20949552]

  (Among 1198 patients with acute liver failure enrolled in a US prospective study between 1998 and 2007, 133 were attributed to drug induced liver injury, only one of which was due to a macrolide antibiotic [clarithromycin] and none were attributed to fidaxomicin).
• Louie TJ, Miller MA, Mullane KM, Weiss K, Lentnek A, Golan Y, Gorbach S, et al.; OPT-80-003 Clinical Study Group. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med 2011; 364: 422-31. [PubMed: 21288078]

  (Among 629 adults with acute, symptomatic C. difficile infection treated with oral vancomycin or fidaxomicin [200 mg twice daily] for 10 days, both response and adverse event rates were similar with both agents; 3 of 300 [1%] fidaxomicin- compared to none of 323 vancomycin-treated subjects had ALT or AST elevations that were considered “serious”, but all resolved upon completing therapy).
• Fidaxomicin (Dificid) for Clostridium Difficile Infection. Med Lett Ther 2011; 53: 23-4. [PubMed: 21921871]

  (Concise review of the pharmacology, efficacy, safety and cost of fidaxomicin in comparison to vancomycin and metronidazole as therapy of C. difficile infection, mentions possible side effects of nausea, vomiting, abdominal pain, hemorrhage, anemia and neutropenia, but does not mention ALT elevations or hepatotoxicity).
• Weiss K, Allgren RL, Sellers S. Safety analysis of fidaxomicin in comparison with oral vancomycin for Clostridium difficile infections. Clin Infect Dis 2012; 55 Suppl 2: S110-5. [PMC free article: PMC3388027] [PubMed: 22752858]

  (Review of the safety of fidaxomicin from preclinical and clinical studies including results from 612 patients with C. difficile infection mentions that fidaxomicin was “well tolerated with a safety profile comparable to oral vancomycin”, with liver test abnormalities arising in 3.2% fidaxomicin- vs 2.6% vancomycin-treated patients, and none in either group developing clinically apparent liver injury with jaundice).
• Chen LF, Anderson DJ. Efficacy and safety of fidaxomicin compared with oral vancomycin for the treatment of adults with Clostridium difficile-associated diarrhea: data from the OPT-80-003 and OPT-80-004 studies. Future Microbiol 2012; 7: 677-83. [PubMed: 22702523]

  (Summary of results from two phase 2 trials comparing fidaxomicin to vancomycin for symptomatic C. difficile associated diarrhea mentions that there were no significant drug-drug interactions and no “alterations of laboratory results attributable to fidaxomicin”).
• Cornely OA, Crook DW, Esposito R, Poirier A, Somero MS, Weiss K, Sears P, et al.; OPT-80-004 Clinical Study Group. Fidaxomicin versus vancomycin for infection with Clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial. Lancet Infect Dis 2012; 12: 281-9. [PubMed: 22321770]

  (Among 535 patients with acute C. difficile infection treated orally with either fidaxomicin or vancomycin for 10 days, cure rates were similar between the two groups [92% vs 91%] and overall and serious adverse event rates were not different; no mention of ALT elevations or hepatotoxicity).
• Fehér C, Múñez Rubio E, Merino Amador P, Delgado-Iribarren Garcia-Campero A, Salavert M, Merino E, Maseda Garrido E, et al. The efficacy of fidaxomicin in the treatment of Clostridium difficile infection in a real-world clinical setting: a Spanish multi-centre retrospective cohort. Eur J Clin Microbiol Infect Dis 2017; 36: 295-303. [PubMed: 27718071]

  (Among 72 Spanish patients with C. difficile infection treated with fidaxomicin, the cure rate was 90% and adverse events were uncommon, although 2 patients had ALT elevations (mild-to-moderate), but neither was attributed to the drug treatment).