Some estradiol medicines are currently experiencing manufacturing issues, here’s what you need to know
There is a current shortage of Climara (estradiol) 25mcg and 75mcg patches (AUST R 73962 and 73963), sponsored by Bayer Australia due to manufacturing issues, the TGA has confirmed.
This shortage is currently expected to continue until 31 March 2019.
“Climara 50mcg and 100mcg patches are not known to be affected by this shortage. TGA also understands that other estradiol patches remain available and consumers who are affected by this shortage may wish to discuss using alternative products with their health professional,” a TGA spokesperson told the AJP.
Femoston (estradiol/dydrogesterone) 1/10 tablets (AUST R 219882), sponsored by Mylan Health are anticipated to be in shortage from 21 to 28 January 2019 due to manufacturing issues.
“Mylan has confirmed there are no supply issues with the other registered Femoston products (Femoston 2/10 and Femoston-Conti) which contain the same active ingredients in different strengths,” a TGA spokesperson stated.
“Different products have been affected over time and therefore the manufacturing issue will vary,” they said.
Back in 2017, estradiol patches from both Novartis and Bayer experienced a serious shortfall.
Shortages to the Novartis products had been occurring since November 2016 due to manufacturing reasons, while Bayer’s Climara Transdermal Patches were in shortage due to “unexpected increase in demand”.
Since then there have been recurrent estradiol shortages in Australia for various products.
For more details of the current and anticipated estradiol shortages visit the TGA website: https://apps.tga.gov.au/Prod/msi/Search/Details/estradiol