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Prescribing testosterone off-licence

If we have suggested that you may benefit from testosterone treatment, you will have heard us mention that it will be prescribed ‘off-licence.’ You may also hear the terms ‘unlicensed medicine’ or ‘off-label’. So what do they mean?

Medicines licensing in the UK

Before a medicine can be used in the UK, it must be granted a licence. While all medicines and treatments have side-effects and risks, a licence tells you that all the proper checks have been done and the benefits of the medicine are believed to outweigh the risks. The licence states what conditions the medicine has been approved to treat.

When a treatment is used off-licence, it means that the medicine has a licence, but it’s not for the condition that you have. In other words, testosterone has not undergone the required, regulated clinical trials to see if it’s effective and safe in treating your condition. But that doesn’t mean it’s unsafe, and it doesn’t mean it won’t work.

There are a number of reasons why a medicine may be unlicensed in the UK. For example, it may be waiting for a licence to be granted, or the need for the medicine may be so small that it doesn’t make commercial sense for the manufacturer to pay for the relevant testing.

Is the off-licence use of testosterone safe?

We would never prescribe anything that we believed to be unsafe.

While testosterone gel isn’t licensed for use in women, only men, it has been prescribed off-licence for treating menopausal symptoms for some time and it’s also endorsed by the National Institute of Clinical Excellence Guidelines on the menopause NG23 2015^[1] .

We have lots of experience prescribing testosterone off-licence and consider all medical evidence available before prescribing it. No medicine is completely free of side-effects and we will discuss the balance of any risks against the benefits you may get, in consultation with you. Our doctors will explain why they think that testosterone is right for you and how it could help with your symptoms. If you’re worried about taking it, always talk to us. We want you to be completely happy that it’s the right choice for you.

If you experience any unpleasant or unexpected side-effects while you’re taking testosterone, please let us know straight away.

Authored by:

Dr Clare Spencer
Registered menopause specialist, GP and co-founder; see Dr Clare in person at The Spire Hospital, Leeds or online

Last updated:

07/04/2021

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