Finasteride

Finasteride is a prescription only tablet used to treat enlarged prostate (benign prostate enlargement). It can also be used to treat hair loss in men, but only via private prescription. Finasteride is generally not recommended for women, although it might be prescribed by a specialist doctor in rare cases.

Licensed versus off-label: what does it mean?

This distinction is one of the most important things pharmacy teams can help customers to understand.

All licensed medicines are reviewed by the UK medicines regulator, the MHRA, and they are either rejected or approved for specific uses, in specific doses for specific groups of patients. The manufacturer will have submitted evidence of safety and efficacy to the MHRA, and the prescribing information reflects what is known about it.

When a prescriber uses a medicine off-label, they are using their professional judgement to prescribe it outside of those MHRA-approved terms, for a different condition, dose, or patient group.

This ‘off-label’ prescribing is legal and sometimes clinically justified, particularly when there is good, published evidence to support it. However, it places additional responsibility on the prescriber to explain the situation to the patient, obtain their consent, and monitor them appropriately.

The concern with the current wave of online prescribing is that some platforms issue prescriptions for off-label hair loss treatments on the basis of a short questionnaire, with limited or no clinical assessment, and minimal follow-up.

Customers may not realise they are taking a medicine that has not been approved for the purpose they are using it for, or they may have cardiovascular or other contraindications that should have been identified before treatment began.