Further to the BMS News Alert issued on 20 February 2025, the MHRA has now provided the British Menopause Society with information about the availability of subcutaneous hormone implants:
Unlicensed hormone replacement therapy (HRT) subcutaneous implants supply issue
Following your recent enquiry, you will be aware of a supply issue regarding HRT subcutaneous implants manufactured by Advanced Pharmaceutical Technology Inc.(APT) in the USA used to treat menopause symptoms. The UK importer and distributor for this product is SmartWay.
The MHRA (Medicines and Healthcare products Regulatory Agency) understands that there have been concerns amongst UK patients and prescribers unable to obtain the unlicensed APT implants. Therefore, this letter provides an explanation of the current situation and is intended to provide some reassurance in the interim.
It is important to note that the APT implants, sold as Estra 25mg and 50mg pellets and the Testo-100 implants, are unlicensed medicines in the UK that are not authorised by the MHRA and have not been assessed for their quality safety or efficacy.
There are legal provisions allowing for unlicensed medicines to be prescribed and supplied to patients when there are no licensed medicines that are available and capable of meeting the special clinical needs of individual patients. Their safety, quality and efficacy are the responsibility of the prescriber responsible for the care of individual patients.
The US Food and Drug Administration (FDA) confirmed previously identified significant risks with the US based manufacturer APT, that could potentially affect products manufactured by them. This was confirmed on an inspection of the manufacturing site carried out last year.
Following the FDA inspection report, SmartWay placed a voluntary hold on the supply of these products, whilst MHRA conducted a regulatory review of the issue. This included working with the Department of Health & Social Care (DHSC) to assess the availability of alternative implants.
The conclusion reached by the MHRA review is that the APT product may be currently the only suitable treatment option for some patients. In view of this we are allowing SmartWay to now supply the remaining imported stock of Estra 25mg and 50mg pellets in the UK to existing patients only, with discussion with their healthcare professional. Alternatives of the Testo product are available.
The MHRA has been informed existing stocks in the UK should be sufficient to meet patient needs for approximately 18 months, whilst alternate sources are sought. Therefore, we encourage patients who have these implants to speak to their healthcare professional and to discuss switching to licensed therapeutic options where possible.
The MHRA is continuing to work with the healthcare system to facilitate the supply of licensed alternatives.
We would be very grateful if you could share this information with your members and networks.
While it’s good news that the implants will be available again shortly, the BMS will review this information to consider if further action is required.