MEN'S HEALTH ∙ 2 minutes read

What does off-label prescribing mean?

By Dr Jaskirt Matharu

Numan sometimes subscribes medication off-label. To give you an in-depth understanding of off-label prescribing, if it’s safe and how it affects you, keep on reading.

Licensing of medications

When a new medication hits the market, it goes through strict processes before it gets its license. In the UK, it’s the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) that carries out licensing for new medicines. They review the medication and the clinical research it has gone through to check that it’s effective and safe. Once the medication has been approved, it gets a product license stating instructions on how to use it, including what health condition it should be used for, who it should be prescribed to and the recommended dosage. 

When all this has been done, the National Institute of Health Care and Excellence (NICE) decides if the medication is to be available on the NHS or not.    

Off-label prescriptions

Sometimes when using a medication, people notice that the medication has other effects than the intended one, so-called side effects. Many times the side effects can be bothersome, but sometimes they turn out to have a positive health effect. This is what happened with semaglutide, the active substance in the medications Rybelsus and Ozempic which are being prescribed to type 2 diabetes mellitus patients in the UK. People who used semaglutide for diabetes started losing weight. After this discovery, doctors started prescribing semaglutide as a weight loss medication. And this is what off-label prescriptions are: UK-licensed medications that are being prescribed for another health condition than the one the medication received its product license for. 

Unlicensed prescription is another term that can be hard to understand and easy to confuse with off-label prescription. An unlicensed prescription usually refers to either a medication that does not have a license at all, or does not have a UK product license, but can still be used as long as the prescriber assesses that it is safe and effective.   

Safety of off-label prescriptions

Prescribing a medication for another health condition that isn’t covered by its UK product license doesn’t mean that it’s unsafe for use. All Numan’s prescribers are trained on medication safety and are responsible for every medication they prescribe. They look at what needs you have, your medical background and what’s the most appropriate medication for you. When a medication is prescribed off-label, the prescriber has assessed that it’s safe for you and that you will have predominant benefits from using it. Off-label medications are only prescribed after careful consideration.

One aspect that might affect you when being prescribed an off-label medication is that you might not find relevant information about your health condition in the Patient Information Leaflet (PIL). This is because the PIL is written based on the product license. This, for example, applies to semaglutide which has a product license to treat patients with type 2 diabetes mellitus. It can also be harder to find information online about the off-label medication and how it affects your health condition. 

When a medication goes through clinical trials, it’s tested on people who are expected to be the group it will be intended for. For semaglutide, that was type 2 diabetes mellitus patients and not necessarily overweight people. For this reason, it’s important to be aware of possible side effects when taking an off-label medication.  

When being prescribed an off-label medication from Numan, you’ll receive clear information about how it works, how much of it you should take (the dosage) and all safety information needed. Be sure to follow the instructions you have been given by your prescriber, especially how much of the medication you should take as this might not be stated in the PIL. If you feel unsure or have any questions, reach out to your health practitioner who will be able to guide you.      

Semaglutide license for weight loss

Semaglutide is used as a treatment for type 2 diabetes mellitus in the UK, and it’s also widely used as a weight loss medication in the US and at private clinics in the UK. It’s currently going through clinical trials so that it can receive a license as a weight loss medication, and so far the results are promising. People who receive semaglutide seem to lose significantly more weight compared to placebo. In the US, semaglutide has already been approved as a weight loss medication and does not need to be prescribed off-label anymore.