Fosfomycin-containing medicinal products

• Fosfomycin antibiotics given into a vein will now only be used to treat serious infections when other antibiotic treatments are not suitable. These include infections affecting the heart, lungs, blood, brain, abdomen, urinary tract, bone, joint and skin and soft tissue.
• Fosfomycin given as granules dissolved in water and taken by mouth will continue to be used in women and adolescent girls to treat uncomplicated infections of the bladder, and in men who are having a tissue sample taken from their prostate (biopsy).
• Some fosfomycin medicines (medicines given by injection into a muscle and granules for children) will no longer be available as there is no evidence that they work well enough.
• If you have any questions about your treatment, speak to your doctor or pharmacist.

EMA has made recommendations for the use of different formulations of fosfomycin:

• Fosfomycin for intravenous use

Intravenous fosfomycin should now only be used for the 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, bacteraemia possibly associated with any of the infections listed above.

• Fosfomycin for oral use

The 3 g granules for oral suspension (fosfomycin trometamol) and oral capsules (fosfomycin calcium) can continue to be used for acute, uncomplicated cystitis in women and adolescent girls. In order for fosfomycin calcium preparations to remain authorised, EMA has asked for further information on the benefits and risks to improve the evidence-base behind its use. Fosfomycin trometamol can also continue to be used prophylactically in men undergoing transrectal prostate biopsy. EMA has asked for further information to support dosage recommendation of this indication.

Fosfomycin is no longer indicated for use for urinary tract infections in children and the paediatric formulation (2 g granules) will therefore be suspended from the market.

• Fosfomycin for intramuscular use

As the evidence supporting the use of intramuscular fosfomycin medicines is not sufficient, these products will also be suspended.

The product information for medicines containing fosfomycin will be updated as required to take these recommendations into account.

Fosfomycin is an antibiotic which has been used for many decades in the EU to treat a range of infections. It is given by mouth as granules (containing fosfomycin trometamol) or as capsules and powder for oral suspension (fosfomycin calcium), by infusion (drip) into a vein or by injection into muscle.

When given by mouth it is mainly used for treating women with uncomplicated urinary tract infections caused by bacteria that are vulnerable to fosfomycin’s antibacterial effects. In some EU countries it has also been used to prevent infections associated with surgical or diagnostic procedures in the urinary tract.

Fosfomycin infusion has been authorised for treating patients of all ages with serious infections such as osteomyelitis (infection of the bone), complicated urinary tract infections, respiratory tract infections that start in hospital, meningitis and bacterial infections in the blood arising from the other infections. Fosfomycin infusion is reserved for use when other antibiotics cannot be used or are not effective.

Fosfomycin for injection into the muscle has been authorised for treating or preventing various infections including infections of the urinary and reproductive systems.

Fosfomycin-containing medicines are available in most EU countries and are marketed under a variety of 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.

The review of fosfomycin medicines was initiated on 7 December 2018 at the request of Germany, under Article 31 of Directive 2001/83/EC.

The review has been carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency’s opinion. The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 9 June 2020.