Promotion of paroxetine by Vir Health Ltd trading as Numan - April 2023
Published 12 July 2023
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A member of the public complained about an email they had received from Vir Health Ltd (trading as Numan). The complainant alleged that a Prescription-Only Medicine, paroxetine, had been promoted to them.
The MHRA contacted Vir Health Ltd. They said that the email was sent to a group of existing patients who had undergone a consultation with Numan for urological symptoms. They also stated that the email was part of an ongoing consultation process, inviting patients to discuss symptoms and any potential treatment options for premature ejaculation.
The MHRA disagreed that the email could be regarded as part of an ongoing consultation process. These patients (number contacted unknown) may not have presented with, or sought help for, the symptoms for which the treatment being promoted was directed. The MHRA considered that the email was designed to promote the prescription, supply, sale, or use of a medicinal product (paroxetine) through the use of claims juxtaposed directly with the name of product, such as “last longer” and “solutions that work”. The MHRA was therefore of the view that the email was likely to lead a member of the public to request a Prescription-Only Medicine, in breach of the Human Medicines Regulations 2012.
The MHRA was particularly concerned because paroxetine has not been formally assessed for safety and efficacy for the indications in which it was presented in the email. The complaint was upheld.
Vir Health Ltd confirmed that they would stop sending targeted emails to Numan customers who have undergone a prior consultation that contain content about specific Prescription-Only Medicines. The company is also undertaking training and a review to ensure compliance with the advertising Regulations in line with Appendix 6 of the MHRA Blue Guide, which outlines that treatment-service providers can promote the service and consultation they provide. The decision to prescribe a medicine outside its licensed indication(s) is a professional matter for the individual prescriber.