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Adverse Events Associated with Fosfomycin Use: Review of the Literature and
Analyses of the FDA Adverse Event Reporting System Database
#MMPMID26437630
Iarikov D
; Wassel R
; Farley J
; Nambiar S
Infect Dis Ther
2015[Dec]; 4
(4
): 433-58
PMID26437630
show ga
INTRODUCTION: The growing problem of antibacterial resistance resulted in an
increased interest in fosfomycin, especially its parenteral formulation. We
reviewed fosfomycin safety profile using the Food and Drug Administration Adverse
Event (AE) Reporting System (FAERS) and published literature. METHODS: We
conducted a FAERS search and disproportionality analysis of all
fosfomycin-associated AEs. We also conducted a FAERS search for AEs implicating
fosfomycin as the primary suspect and a search of reports of
fosfomycin-associated bone marrow toxicity. We then review the literature for
publications reporting AEs associated with fosfomycin by conducting PubMed
searches. RESULTS: The disproportionality analysis of all FAERS reports of
fosfomycin-associated AEs produced a higher than expected frequency of
agranulocytosis, liver injury, severe skin reactions, and pseudomembranous
colitis. Subsequent search for AEs where fosfomycin was the primary suspect and
the literature review did not suggest a higher association of fosfomycin with
these AEs. The search of bone marrow toxicity reports did not demonstrate an
association between aplastic anemia and fosfomycin. The literature review
selected 23 trials of parenteral administration of fosfomycin in 1242 patients
including 8 comparative and 15 non-comparative trials. For oral fosfomycin, only
prospective comparative trials (n = 28) in 2743 patients were included. The most
frequent AEs associated with parenteral fosfomycin included rash, peripheral
phlebitis, hypokalemia, and gastrointestinal disorders. Serious AEs such as
aplastic anemia, anaphylaxis, and liver toxicities were reported infrequently.
Gastrointestinal disorders were the most common AEs associated with oral
fosfomycin. CONCLUSION: The identified AEs were consistent with the safety
profile of fosfomycin. No new safety signals related to either parenteral or oral
fosfomycin were identified.