Fosfomycin-containing medicinal products

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  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
Opinion provided by Committee for Medicinal Products for Human Use

Overview

Recommendations to restrict use of fosfomycin antibiotics​

EMA has recommended that fosfomycin medicines given by infusion (drip) into a vein should only be used to treat serious infections when other antibiotic treatments are not suitable. Fosfomycin medicines given by mouth can continue to be used to treat uncomplicated bladder infections in women and adolescent girls. They can also be used to prevent infection in men who undergo a procedure whereby a tissue sample is taken from their prostate (biopsy).

EMA further recommends that fosfomycin medicines given by mouth to children (under 12 years of age) and intramuscular formulations (fosfomycin medicines for injection into a muscle) should no longer be used as there are insufficient data available to confirm their benefits to patients.

These recommendations follow a review by EMA’s human medicines committee (CHMP) of the safety and effectiveness of these antibiotics.

Fosfomycin-based antibiotics first became available in the 1960s, but their use quickly decreased in favour of other antibiotics with fewer potential side effects. 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 review aimed to determine the place of fosfomycin in the treatment of infections, taking into account the latest available evidence. It concluded that:

  • fosfomycin given into a vein should now only be used for treating certain serious infections such as those affecting the heart, lungs, blood and brain or those that are difficult to treat such as complicated infections of the abdomen, urinary tract or of the skin and soft tissue.
  • fosfomycin, for use by mouth, can continue to be used for treating uncomplicated cystitis in women and adolescent girls. Fosfomycin granules (which contain fosfomycin trometamol) can also continue to be used in men undergoing biopsy of the prostate. EMA asked companies for further data to justify the continued use of oral medicines containing fosfomycin trometamol and fosfomycin calcium.
  • intramuscular fosfomycin and fosfomycin granules for children (2 g) should be suspended as there is no clear evidence that they are sufficiently effective for their currently authorised uses.

Key facts

Approved name
Fosfomycin-containing medicinal products
International non-proprietary name (INN) or common name

fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol

Associated 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
  • Uroseptic
Class
Antibiotics
Reference number
EMEA/H/A-31/1476
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Status
Opinion provided by Committee for Medicinal Products for Human Use
Opinion date
26/03/2020

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

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