EMA Restricts Fosfomycin Use Following Evidence Review

Megan Brooks


April 03, 2020

The European Medicines Agency (EMA) has recommended a number of changes regarding the use of fosfomycin-based antibiotics, including recommending the suspension of use of pediatric and intramuscular formulations, following a review by the EMA's Committee for Medicinal Products for Human Use (CHMP).

Fosfomycin-based antibiotics have been available since the 1960s, but their use has decreased in favor of other antibiotics, the EMA explains in a statement.

"Due in part to their limited use, fosfomycin antibiotics are still active against a number of bacteria that have become resistant to commonly used antibiotics. In recent years, this has led to an increase in the use of fosfomycin in patients with few other treatment options," the agency said.

In December 2018, the CHMP announced it would reevaluate the authorized uses and doses "in the light of up-to-date-knowledge" on antibacterial therapy.

At the committee's March meeting, the panel made the following recommendations regarding the use of various formulations of fosfomycin-based antibiotics.

For Intravenous Use

The use of intravenous fosfomycin should be limited to treatment of the following serious infections when other antibiotic treatments are not suitable: complicated urinary tract infections; infective endocarditis; bone and joint infections; hospital-acquired pneumonia, including ventilator-associated pneumonia; complicated skin and soft tissue infections; bacterial meningitis; complicated intra-abdominal infections; and bacteremia that could be associated with any of these infections.

For Oral Use

The CHMP recommended that use of the 3-g granules for oral suspension (fosfomycin trometamol) and oral capsules (fosfomycin calcium) for acute, uncomplicated cystitis in women and adolescent girls be continued. The EMA has asked for more information on the benefits and risks associated with fosfomycin calcium preparations in order to decide whether to continue authorizing use of these preparations.

Prophylactic use of fosfomycin trometamol in men who are to undergo transrectal prostate biopsy should continue. The EMA has asked for more information to support dosage recommendations for this indication.

Use of fosfomycin for urinary tract infections in children should stop; the pediatric formulation (2-g granules) will be pulled from the market.

For Intramuscular Use

Intramuscular fosfomycin medicines will be suspended because there is insufficient evidence supporting the use of these products.

Fosfomycin-containing medicines are available in most European Union countries and are marketed under the following names: Afastural, Berny Adulti, Danifos Adulti, Fomicyt, Fosfocin, Fosfocina, Fosfocine, Fosfopharm, Fosfuro, Fosmol, Fostrofemge, Gynofostrome, Infectofos, Infeur Adulti, Interfos, Monural, Monuril, Monurol, Rapidnorm, Solufos, Symural, Uridoz, Urifos, Urinex, Urofast, Uromaste, and Uroseptic.

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