What Is Off-Label Prescribing? A Guide For GLP-1 Patients

If you're exploring treatment options for weight management, you may have come across the term "off-label".

Off-label prescribing is a common practice across healthcare, but it's also sometimes misunderstood. In this article, we'll explore what off-label medications are, how (and why) they're used and what it could mean for your care.

Article Summary:

• “Off-label prescribing” is using an approved medicine in a way that's different from how it's officially licensed.
• Off-label prescriptions are safe, legal and commonly practised. However, as with any prescription medication, off-label treatments should always be prescribed and monitored by a licensed healthcare professional.
• Under certain conditions, off-label prescriptions may be suitable for GLP-1 weight loss and weight management treatment.

What is an off-label prescription?

To sell a medicine in the UK, a pharmaceutical company must first have a product licence (or Marketing Authorisation). This is secured by collecting clinical data from trials, which is then sent to the MHRA (the Medicines and Healthcare products Regulatory Agency) for approval. [1]

This licence explains how the drug can be used: for example, what the drug can be used for (its “indication”), how much can be used per dose and who it may be given to (e.g. a specific age group). [2] This information is outlined in a medication's Summary of Product Characteristics (SmPC). [3]

"Off-label prescribing" is when a healthcare professional prescribes a licensed medication in a way that differs from its officially approved usage.

This could mean:

• It's licensed for a specific condition, but healthcare providers know it can also help with a different condition.
• Prescribing it for a different age group (off-label use is fairly common in paediatric and neonatal care).
• Prescribing a different dose, which healthcare providers believe may be more suitable for certain patients.
• Prescribing it for a different route (like a liquid instead of a tablet). [4, 5, 6]

To put it simply, the medication itself is licensed, but the specific use isn't.

Is off-label prescribing safe?

Yes, off-label prescribing is safe and legal, and it's widely practised by healthcare providers in the UK. The medication itself is fully regulated and approved for use. "Off-label" simply refers to how it's used.

Sometimes people confuse the terms "off-label" and "unlicensed". It's important to understand the difference between the two.

Unlike off-label prescriptions, where medication use is outside the terms of the Marketing Authorisation, an unlicensed medicine either has no Marketing Authorisation in the UK, or its Marketing Authorisation has been withdrawn. [7]

At MedExpress, the branded weight loss medications we prescribe (like Mounjaro and Wegovy) are all fully licensed in the UK. Our prescribers will only issue them off-label when they think it's safe and appropriate for you. If one of our clinicians believes that off-label medication is right for you, we’ll let you know and explain why.

Any medication use, whether on or off-label, may cause side effects. Always remember to make your healthcare provider aware of any underlying medical conditions and read the full patient information leaflet (PIL) before you begin a treatment.

If an off-label use is safe, why isn't it recognised in the official licence?

The process to license a drug can be very expensive, because it involves clinical trials. This is why sometimes, once a type of medication is approved and available, its company may not extend a medication's licence to cover alternative uses (even if it's found to treat or prevent other medical conditions).

Why might a healthcare provider prescribe a medication off-label?

Sometimes, a prescriber may decide that an off-label medication is the best treatment option for you.

This comes down to:

• Whether there's enough scientific evidence to support its use.
• The clinical judgement of your healthcare provider.

Off-label prescriptions and GLP-1s

In the UK, two widely used prescription medicines authorised for weight management are Mounjaro and Wegovy. [8, 9] Saxenda is also approved. [10] Their prescription is subject to strict eligibility criteria. This is determined by your BMI, and any medical conditions you may have.

The off-label use of GLP-1 treatment may not be suitable for everyone. Our clinicians assess each consultation on a case-by-case basis, taking into account your individual circumstances. This is to make sure that all treatments are prescribed appropriately, with patient safety as the priority.

Off-label prescriptions and GLP-1s: switching treatments

If you've begun weight loss or weight management treatment with one type of GLP-1 medication, you may decide you'd like to switch to another form of treatment.

In this case, your MedExpress clinician will recommend which dose to switch to based on your current treatment dose. This is classed as off-label use, because your new treatment starting dose may be higher than the licensed starting dose. However, this may help you to smooth your transition and maintain your progress.

When switching GLP-1 treatments, you may feel more comfortable beginning your new treatment at the lowest licensed starting dose and slowly increasing it over time, rather than starting closer to your current dose level. That’s completely fine. Our role is to support your treatment, and make it as comfortable and safe as possible for you.

Off-label medication is safe, as long as it’s prescribed by a licensed healthcare provider. Remember that the prescription of off-label medication use should only take place if it's considered the most appropriate treatment for you, and will only be prescribed by your healthcare provider once your other options have also been considered. [2]

If you’d like to learn more about off-label prescribing and whether it may be appropriate for you, our MedExpress clinicians can assess your individual treatment history, current medication and weight loss goals to help determine the safest option. You can explore more information about Mounjaro, Wegovy and other available weight loss treatments.

References

1. Unlicensed And Off Label Medicines [Internet]. University Hospitals Sussex NHS Foundation Trust. 2022. Available from: https://www.uhsussex.nhs.uk/resources/unlicensed-and-off-label-medicines/
2. Unlicensed and “Off-label” Medicines Information for patients, parents and carers [Internet]. Available from: https://www.ouh.nhs.uk/media/wcniy5dl/72458unlicenced.pdf
3. Aronson JK, Ferner RE. Unlicensed and off‐label uses of medicines: definitions and clarification of terminology. British Journal of Clinical Pharmacology. 2017 Sep 26;83(12):2615–25.
4. Wyllie T. P17 Licensed, unlicensed or off-label? A snapshot of medicines used in neonatal intensive care. Archives of Disease in Childhood. 2023 Apr 19;108(5):9.2-10.
5. Wittich CM, Burkle CM, Lanier WL. Ten Common Questions (and Their Answers) About Off-label Drug Use. Mayo Clinic Proceedings [Internet]. 2012;87(10):982–90. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538391/
6. Medicines and Healthcare products Regulatory Agency. Off-label or Unlicensed Use of medicines: Prescribers’ Responsibilities [Internet]. www.gov.uk. 2014. Available from: https://www.gov.uk/drug-safety-update/off-label-or-unlicensed-use-of-medicines-prescribers-responsibilities
7. Off-label and unlicensed prescribing | Right Decisions [Internet]. Scot.nhs.uk. 2017 [cited 2026 Jun 2]. Available from: https://www.rightdecisions.scot.nhs.uk/mypsych-app/working-in-greater-glasgow-clyde/medicines-companion/non-formulary-unlicensed/off-label-and-unlicensed-prescribing
8. Package leaflet: Information for the patient wegovy FlexTouch [Internet]. Available from: https://www.medicines.org.uk/emc/files/pil.13800.pdf
9. Package leaflet: Information for the patient Mounjaro ® 2.5 mg KwikPen ® solution for injection in pre-filled pen Mounjaro ® 5 mg KwikPen ® solution for injection in pre-filled pen Mounjaro ® 7.5 mg KwikPen ® solution for injection in pre-filled pen Mounjaro ® 10 mg KwikPen ® solution for injection in pre-filled pen Mounjaro ® 12.5 mg KwikPen ® solution for injection in pre-filled pen Mounjaro ® 15 mg KwikPen ® solution for injection in pre [Internet]. Available from: https://www.medicines.org.uk/emc/files/pil.15481.pdf
10. Package leaflet: Information for the patient Saxenda® 6 mg/ml Solution for injection in pre-filled pen liraglutide [Internet]. Available from: https://www.medicines.org.uk/emc/files/pil.2313.pdf