Source: Radio New Zealand
Garo Phanie / AFP
A group of women who have had ongoing issues with Estradot patches says they feel like they’ve been heard after Medsafe told them it was initiating independent testing.
A number of women have reported problems with the oestrogen patches not adhering or working properly, which has caused some of their perimenopause symptoms to return
Manufacturer Sandoz told RNZ it had received about 50 complaints from New Zealand, while Medsafe said it had received 149 complaints.
On Friday, Medsafe officials met with met some of the women to better understand what issues were being experienced.
Bronda Smith, who is the administrator for an online menopause support group, told Morning Report the meeting was encouraging.
“We really felt heard, which was great.”
She said one of the biggest wins of the meeting was Medsafe initiating independent testing.
Smith said Manufacturer Sandoz has done some testing of stock in the US.
“So, they didn’t test the actual batches that were delivered to New Zealand.”
She said the group was also concerned the issue was wider than first thought after finding a Menopause Support Group in the UK had also raised concerns about Estradot last year.
“It’s starting to feel like we’re being a little bit being told porkies by Sandoz,” she said.
In a statement, Sandoz said it had conducted a thorough investigation following the recent complaints and have completed retesting of retained samples of batches distributed in New Zealand.
“We are in discussion with Medsafe and have provided a detailed rationale explaining why local testing in New Zealand is not feasible. This is due to the unavailability of validated laboratories to conduct the tests, the complexity of the product, the nature of the adhesive technology, and the validated processes in place at the manufacturing site.”
It said it fully supported Medsafe conducting its own independent testing and would continue to work closely with them to ensure all regulatory expectations are consistently met.
A Ministry of Health spokesperson said Medsafe took all complaints seriously and started investigating as soon as the first complaints were received.
“This included getting information from the company, their test results for the batches concerned, and assurance of quality from the manufacturing site,” they said.
“Medsafe has initiated independent testing (with PHF here in New Zealand) of batches that have arrived in New Zealand, on top of what the company has done. This may take some time but helps us to work out why we might be receiving complaints when other countries (such as Australia) are not. We are also checking in with our counterparts internationally, where the patches are also supplied.”
The spokesperson said Medsafe would continue to publish updated information on its website.
“We acknowledge that earlier communication about Medsafe’s role may have been helpful for those affected and we will continue to keep the support group and other interested stakeholders updated as the investigation continues.”
The spokesperson said the product did appear to still be working for the majority of women.
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– Published by EveningReport.nz and AsiaPacificReport.nz, see: MIL OSI in partnership with Radio New Zealand
