Further to the BMS News Alert issued on 20 March, the MHRA has now provided a statement with regard to the availability of subcutaneous hormone implants.
Julian Beach, MHRA Interim Executive Director for Healthcare Quality and Access, said:
“We are committed to ensuring timely access to treatment for UK patients, and this includes HRT products.
“Following some compliance issues raised with MHRA following a US FDA Good Manufacturing Practice (GMP) inspection at a manufacturing site of Advanced Pharmaceutical Technology Incorporated in the USA, we initially paused the import of Estra 25mg and 50mg pellets into the United Kingdom.
“A review of the available information so far has found no evidence of harm caused by these implants, which have been used for over 10 years in the UK.
“We are aware that these unlicensed medicines are critical for a specific group of patients and as suitable alternatives are currently unavailable, further imports of these medicines to the UK market will continue while we conclude a regulatory review.
“We will communicate our findings once this review has concluded. In the meantime, there is no need for any action by patients.’’