Other considerations

Medicines safety

Vancomycin

Vancomycin is a glycopeptide that is taken orally to treat Clostridioides difficile infection. With oral use, the company advises monitoring serum vancomycin concentration in people with inflammatory intestinal disorders in which absorption may be enhanced. It also advises that serial auditory function tests may help to minimise the risk of ototoxicity in people with an underlying hearing loss, or who are having concomitant therapy with other ototoxic drugs. In renal impairment or in people having concomitant treatment with an aminoglycoside or other nephrotoxic drug, the manufacturer advises serial monitoring of renal function. The manufacturer advises that vancomycin should be used in pregnancy only if the potential benefit outweighs the risk. Prolonged use of vancomycin may result in the overgrowth of non-susceptible organisms. Acquired resistance to glycopeptides is most common in enterococci, in which multiresistant strains have been seen (see BNF information on vancomycin and vancomycin summary of product characteristics).

Fidaxomicin

Fidaxomicin is a macrocyclic antibacterial that is poorly absorbed from the gastrointestinal tract, so is not used to treat systemic infections. It is taken orally to treat C. difficile infection. Common side effects when taken orally for C. difficile infection include constipation, nausea and vomiting. The manufacturer advises that it is preferable to avoid using fidaxomicin in pregnancy as a precaution (see BNF information on fidaxomicin and fidaxomicin summary of product characteristics).

Faecal microbiota transplant

In NICE's interventional procedures guidance on faecal microbiota transplant for recurrent C. difficile infection, it states that 'The US Food and Drug Administration has advised that stool donors for faecal microbiota transplantation should be screened with questions that specifically address risk factors for colonisation with multidrug-resistant organisms (MDROs), and individuals at higher risk of colonisation with MDROs should be excluded as donors. In addition, donor stool should be specifically tested for MDROs and not used if positive'. While short-term safety and adverse events with a faecal microbiota transplant were reported in the included studies for this guidance, the committee identified that longer-term safety of the procedure is not yet known.

Medicines adherence

Medicines adherence may be a problem for some people taking antibiotics that need frequent dosing or longer treatment duration (see NICE's guideline on medicines adherence).

Resource implications

See the economic analysis in the evidence review for detailed costs, including estimated costs of a faecal microbiota transplant. Vancomycin capsules and powder for solution are available as generic formulations. Fidaxomicin tablets are a proprietary product.

  • National Institute for Health and Care Excellence (NICE)