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Fosfom
osfomyycin for treating urinary tr
tract
act infections
caused b
byy bacteria that are resistant to more
than one antibiotic
Information for the public
Published: 23 July 2013
nice.org.uk
About this information
This information explains the evidence summary about the use of fosfomycin for treating urinary
tract infections caused by bacteria that are resistant to more than one antibiotic ('multidrugresistant bacteria'). The evidence summary is an overview of the available information about this
medicine. It aims to help prescribers and patients when they are considering whether or not to use
this treatment. The summary does not contain recommendations from NICE on whether the
medicine should be used.
Licensing medicines
In the UK, medicines need to have a licence before they can be marketed. To get a licence, the
manufacturer of the medicine has to provide evidence that shows that the medicine works well
enough and is safe enough to be used for a specific condition and for a specific group of patients,
and that they can manufacture the medicine to the required quality. Medicines can be prescribed
without a licence (an 'unlicensed medicine') if there is no suitable licensed alternative and it is likely
to benefit the patient.
A medicine can also be prescribed 'off-label'. This means the prescriber wants to use it in a different
way than is set out in the terms of its licence. This could mean using the medicine for a different
condition or a different group of patients, or it could mean a change in the dose or that the medicine
is taken in a different way. There is more information about licensing medicines on NHS Choices.
© NICE 2013. All rights reserved.
Page 1 of 4
Fosfomycin for treating urinary tract infections caused by bacteria that are resistant to more than one
antibiotic
What are urinary tr
tract
act infections?
Urinary tract infections are infections in one or more parts of the urinary tract (the kidneys and the
tubes and storage vessels, including the bladder, that take urine produced by the kidneys out of the
body).Urinary tract infections are usually caused by bacteria.
Symptoms of urinary tract infections include difficulty and pain when passing urine, needing to go
to the toilet more frequently, producing more urine than normal, needing to pass urine urgently,
blood in the urine, and pain in the belly (directly above the pubic bone), or in the lower back or
abdomen.
About fosfom
fosfomyycin
Fosfomycin is an antibiotic, which is a type of drug that kills bacteria.
Fosfomycin is licensed in the UK for treating infections in the lower urinary tract (the bladder and
urethra, the tube that carries urine from the bladder out of the body). However, it is not currently
marketed in the UK and pharmacists need to import it from abroad. Use of drugs which are
imported from abroad is unlicensed in the UK. Systems are in place to make sure that the
fosfomycin complies with UK regulations.
Other antibiotics are usually used to treat urinary tract infections but fosfomycin is sometimes
used when the bacteria causing the infection are resistant to other antibiotics. Some bacteria that
cause urinary tract infections are resistant to more than one antibiotic. These are called 'multidrugresistant' bacteria.
Summary of possible benefits and harms
How well does fosfomycin work?
Four small studies looked at how well fosfomycin worked for treating urinary tract infections
caused by multidrug-resistant bacteria.
Two studies compared fosfomycin with another antibiotic treatment. In these 2 studies, the
symptoms of urinary tract infection disappeared in a similar number of people receiving fosfomycin
and people receiving another antibiotic. The other 2 studies didn't compare fosfomycin with
another antibiotic treatment, but looked at how well fosfomycin had worked in people who had a
urinary tract infection.
© NICE 2013. All rights reserved.
Page 2 of 4
Fosfomycin for treating urinary tract infections caused by bacteria that are resistant to more than one
antibiotic
Three of the studies looked at the number of people whose symptoms of urinary tract infection
disappeared after fosfomycin treatment. They found that fosfomycin cured the symptoms in at
least three quarters of people. The other study found that, after treatment with fosfomycin,
bacteria were no longer detected in the urine of 12 of every 20 patients
What are the possible harms or side effects?
In 2 of the studies, people taking fosfomycin had no side effects. The other 2 studies did not report
any information on side effects.
Fosfomycin can occasionally cause people to feel sick, or to have diarrhoea, heartburn and
indigestion, or skin rashes. Inflammation of the vagina, headache, dizziness and weakness have also
been reported by people taking fosfomycin. Allergic reactions can also occur. However, fosfomycin
does not cause any more side effects than other antibiotics used to treat urinary tract infections.
Please note that the results of the research study only indicate the benefits and harms for the
population in the study. It is not possible to predict what the benefits and harms will be for an
individual patient being treated with fosfomycin.
Prescribing fosfom
fosfomyycin
If a prescriber wants to use an unlicensed or off-label medicine, they must follow their professional
guide, for example for doctors the General Medical Council's good practice guidelines. These
include giving information about the treatment and discussing the possible benefits and harms so
that the patient has enough information to decide whether or not to have the treatment. This is
called giving informed consent.
A full version of the summary aimed at healthcare professionals is available on the NICE website.
The summary for healthcare professionals does not contain recommendations from NICE on
whether the medicine should be used.
Questions to ask
Why am I being offered this medicine?
What does the treatment involve?
What are the benefits I might get?
© NICE 2013. All rights reserved.
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Fosfomycin for treating urinary tract infections caused by bacteria that are resistant to more than one
antibiotic
How good are my chances of getting those benefits?
Could having the treatment make me feel worse?
Are there alternative treatments?
What are the risks of the treatment?
Are the risks minor or serious? How likely are they to happen?
What may happen if I don't have the treatment?
More information
The evidence summary and this information for the public were produced for NICE by Bazian Ltd.
NICE has published information about how evidence summaries for unlicensed and off-label
medicines are developed.
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© Bazian Ltd, 2013. All rights reserved. This material may be freely reproduced for educational and
not-for-profit purposes. If you wish to reproduce this information for use by commercial
organisations or for commercial purposes, please email NICE.
Contact NICE
National Institute for Health and Care Excellence
Level 1A, City Tower, Piccadilly Plaza, Manchester M1 4BT
www.nice.org.uk; [email protected]; 0845 003 7780
© NICE 2013. All rights reserved.
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