TGA Review of Vaginal Oestrogen Consumer Medicines Information
Vaginal oestrogen consumer medicines information is under review by Therapeutic Goods Administration (TGA). USANZ Member, Dr Ailsa Wilson Edwards, is the RACS-nominated representative to the TGA Womens Health Products Working Group. Ailsa prepared the following commentary about how these changes may impact USANZ Members.
Concerns about incorrect claims made in consumer medicines information for vaginal oestrogen products have been raised by USANZ to the Senate Inquiry into Menopause.
The product leaflets raise fears around risks of cancer, heart disease, stroke and dementia which are out of step with current research supporting vaginal oestrogen’s safety. Such misinformation is harmful to women suffering from genitourinary symptoms of menopause, who may unnecessarily avoid effective treatment. Extensive safety data is available, including in women with a personal history of breast cancer; for example in the UK vaginal oestrogen has been available over the counter without prescription since 2022. USANZ appealed to the Senate Inquiry to correct this.
RACS has drawn attention to this and this issue is of high interest at the TGA via the Womens Health Products Working group, drawing wide support from womens health stakeholders including RANZCOG.
Of interest to USANZ members, in Australia there are two mechanisms by which consumers medicine information can be updated:
- Sponsor-initiated change
- The TGA undertakes a full review of the evidence
RACS and USANZ will continue this advocacy in the coming months.
USANZ thanks Ailsa for her continued advocacy work in this space.