Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether he has made an assessment of the potential impact of the sales Finasteride medications through telehealth companies on an increase in the level of cases of Post-Finasteride Syndrome in the past 12 months.

The Medicines and Healthcare products Regulatory Agency’s (MHRA) role is to continually monitor the safety of medicines during their use. We have robust, safety monitoring and surveillance systems in place for all healthcare products, including finasteride. As part of our monitoring and surveillance activities, we take into account any changes in the usage of a particular medicine.

Finasteride containing medicines are prescription only medicines. This means they must be prescribed by a doctor or other authorised health professional, and must be dispensed from a pharmacy or from another specifically licensed premises.

The MHRA has recently completed an extensive safety review into finasteride, with the subsequent updates to the product information having been implemented, and the development of a patient alert card is underway. We also published a Drug Safety Update to raise awareness amongst healthcare professionals of the adverse psychiatric and sexual side effects. We are aware that the European Medicines Agency has launched a review, and we are monitoring this closely. Further information on the Drug Safety Update is available at the following link:

https://www.gov.uk/drug-safety-update/finasteride-reminder-of-the-risk-psychiatric-side-effects-and-of-sexual-side-effects-which-may-persist-after-discontinuation-of-treatment

Please be reassured that the MHRA continuously monitors the safety of finasteride via information from various sources, including the published literature. Information from all sources is carefully screened and may identify unexpected side effects, indicate that certain side effects occur more commonly than previously believed, or that some patients are more susceptible to some effects than others. If a new side effect is identified, information is carefully considered in the context of the overall side effect profile for the medicine. When necessary, the MHRA may take action to ensure that a medicine is used in a way which minimises risk and maximises benefits to the patient.