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Menopausal Hormone Therapy Shortages in Australia - Update 9 December 2020

There has been a recent shortage of a number of menopausal hormone therapy (MHT) preparations and some of these have now been or soon will be resolved:

Oral MHT

Femoston 1/10 – resolved

Duavive – supply due to be resolved by April 2021

Angeliq - resolved 

Transdermal

Climara – resolved

Estradot 100 – resolved

Estradot 75 – supply due to be resolved by the end of December

Estradot 50 – supply due to be resolved by the end of December

Estradot 37.5 – resolved

Estradot 25 – supply due to be resolved by the end of December

Estalis Conti - supply due to be resolved by end of December

Estalis Sequi –supply due to be resolved by March 2021

Estrogel/Estrogel Pro 

Estrogel/Estrogel Pro - resolved

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Early Menopause Webinars – 3 Part Series

Want to Know more about Early Menopause?

Early menopause changes you. You physically have changed. You emotionally change. You psychologically change.

Join a panel of leading experts and women with lived experience of early menopause with an opportunity to ask your questions.

EM Webinars for women 2020

Healthtalk Australia

Click on links below to register:

19 October 2020, 2:30 pm – Spontaneous Early Menopause

16 November 2020, 10:00 am – Early Menopause associated with gynecological cancer

30 November 2020, 10:30 am - Early Menopause associated with breast cancer

Even if you can’t join live, register now and we’ll send you the recorded webcast to watch at your convenience.

For further information please email: This email address is being protected from spambots. You need JavaScript enabled to view it. 

pdfEarly Menopause Webinars – 3 Part Series Flyer235.64 KB

 EM sponsors

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A Current Affair - Linking Menopausal Hormone Therapy (MHT) and Breast Cancer

On 23 September, A Current Affair screened a segment featuring Blanche D’Alpuget (the late Bob Hawke’s wife) which may raise some concerns for your patients. In the segment she discusses how she was diagnosed with breast cancer after her MHT dosage was increased. Dr Kerryn Phelps was also interviewed and claimed that the recent evidence shows that MHT ‘triples’ the risk of breast cancer.

Dr Phelps references the Lancet study published in August last year.

We refer you to the excellent paper written by Professor Susan Davis, President, International Menopause Society and AMS Past-President in response to the Lancet paper, to assist you in discussion about the risks and benefits with your patients.

www.menopause.org.au/hp/gp-hp-resources/1483-menopause-matters

We also refer you to our Fact Sheet and Infographic on “What is MHT and is it safe?” which is a good resource for your patients.

www.menopause.org.au/health-info/fact-sheets/what-is-menopausal-hormone-therapy-mht-and-is-it-safe

www.menopause.org.au/health-info/infographics/what-is-menopausal-hormone-therapy-and-is-it-safe

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iCARE Covid-19 International Survey 4

covid surveyFor the past few months, people have been feeling the impacts of COVID-19 on their daily lives. 
 
Help us understand those impacts and make a real change by completing and sharing our iCARE survey in your networks.

Survey 4: mbmc-cmcm.ca/covid19

We are releasing monthly versions of the survey. We invite you to fill out each version as it becomes available and to share it in your networks, whether you have filled previous versions or this is your first participation. Each time you fill or share the survey, it will allow us to follow the evolution of COVID-19’s effects on communities worldwide. 

More than 60 000 people from 140 countries have completed the survey (available in multiple languages), and we are still going! 

Take the survey

Preliminary results are now available at: mbmc-cmcm.ca/covid19/stats-wave1 (keep checking the website for results updates as they come in!). Thanks to your participation, we have learned what people think of government public health policies and COVID-19-related restrictions, and how people are coping with the pandemic.

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Shortage of Menopause Hormone Therapy Update - 24 June 2020

Recently a number of menopause hormone therapy (MHT) products have been unavailable or in short supply.  Brand names including Climara, Angeliq and Duavive have been affected, and the TGA has advised that there are anticipated shortages of various doses of Estradot and Estalis Sequi until July 2021 (apps.tga.gov.au/prod/msi/Search/Details/estradiol). The shortages are due to a change in manufacturing processes that require a new approval by the TGA which can take up to six months. New Zealand has already approved the new manufacturing process for Estradot. In an effort to maintain the availability of Estradot,   the TGA have agreed to allow an ‘unregistered product’ to be supplied in Australia. This unregistered product is the one that is supplied in New Zealand – same name (Estradot) and same dosage as Australia but it has different packaging and Australian Registered Number. The TGA anticipate that supply should be sufficient now that there is authority to distribute the New Zealand approved product.

However, as Estalis Sequi is not registered in New Zealand, the same mechanism for supply in Australia cannot be used. Sandoz are expecting that there will be critical supply issues between August and September 2020. Sandoz/TGA will be writing to all relevant health professionals about the supply issue and advise of alternative prescriptions. Sandoz have also advised that the TGA will expedite the approval process and they anticipate that approval should be reached by around September 2020.

Prescribers should check the AMS Guide to Equivalent MHT/HRT Doses to guide them on prescription alternatives. Options to replace Estalis Sequi include:

  • Estradot combined with a progestogen
  • Estrogel Pro
  • Oral MHT if appropriate

Patients who are having issues with filling their prescription are encouraged to see their doctors to discuss alternative options.

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Shortage of Menopause Hormone Therapy - 22 May 2020

The Therapeutic Goods Administration (TGA) has advised that there are currently and/or anticipated shortages of various doses of Estradot, Estalis Sequi and Climara patches in Australia.

Please see information here: http://apps.tga.gov.au/prod/msi/Search/Details/estradiol

Supply of Estraderm, Sandrena and Estrogel have not been affected and may be good alternatives for Estradot and Climara. If substituting Estraderm, Sandrena or Estrogel for Estalis Sequi, a progestogen will need to be added. Please see the AMS Guide to Equivalent MHT/HRT Doses to review the alternative options available.

There are also shortages of Angeliq and Duavive. Alternative options are available for these (such as Femonston-Conti, Kliovance, Estrogel Pro, Livial, Xyvion and Kliogest) so please check the AMS Guide to Equivalent MHT/HRT Doses to review alternative options.

Patients who are having issues with filling their prescription are encouraged to see their doctors to discuss alternative options.

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Launch of Healthtalk Australia Early Menopause digital resource for women and health professionals

Over the last three years, aligned with our strategic mission of fostering partnerships, AMS has been a partner in a NHMRC Partnership grant together with universities, hospitals, other medical societies, non-government organisations and support groups. This project involved the co-design and development of a comprehensive digital resource for women with early menopause (EM) and health professionals (HPs) featuring their experiences, and perspectives (audio and video clips), a question prompt list with weblinks to information, evidence based diagnosis and management algorithms and resource lists. The resource is designed to support, inform and help with diagnosis, management and improved communication between women and their HPs for better health outcomes. The research team and participating HPs involved a number of AMS members and there is a link from the AMS website to the Early menopause resource. The Early Menopause digital resource was launched at Women’s Health Victoria by The Hon. Gabrielle Williams, Victorian Minister for Prevention of Family Violence, Minister for Women and Minister for Youth on November 4, 2019 with participants, members of the research team, partner representatives and invited guests attending. The research team would like to thank all participants, reference group members and partners involved.  

launch photo

To access the Early menopause digital resource:

https://healthtalkaustralia.org/early-menopause-experiences-and-perspectives-of-women-and-health-professionals/

health talk website

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Experts rip into HRT-cancer study

From The Medical Republic - 9 September 2019

A large study in The Lancet has thrown shade on hormone replacement therapy again by linking it to breast cancer, but experts say the data reflect old prescribing habits and that the benefits of HRT outweigh the risks for many women.

The study was conducted by a group of UK epidemiologists, called The Collaborative Group on Hormonal Factors in Breast Cancer, that have been collecting worldwide data on HRT (also now known as Menopausal Hormone Therapy or MHT) for decades.

Their latest meta-analysis pooled data from 58 observational studies, including about 600,000 women.

The study found that all types of HRT were associated with an excess risk of breast cancer, except topical vaginal oestrogen.

The risk was higher in post-menopausal women who used HRT for longer periods of time, and in women who used HRT more regularly.

Oestrogen-progestogen carried a higher risk of breast cancer than oestrogen-only therapy, and the risk increased over time.

After five to 14 years on oestrogen-progestogen, the risk of breast cancer had doubled compared with never-users.

If these relationships were found to be causal, around one million cases of breast cancer could be linked to HRT use since 1990, the authors estimated.

But these conclusions have been soundly refuted by Australian experts.

It had been known for some time that HRT slightly elevated the risk of breast cancer, but this study was probably overexaggerating the risks, Professor Susan Davis, the president of the International Menopause Society and an endocrinologist based in Melbourne, said.

The paper in The Lancet was based on observational research, which could not control for unknown confounders and could therefore be misleading, she said.

The risks of breast cancer reported by the Women’s Health Initiative (WHI) were probably closer to the truth, Professor Davis said.

The WHI was a randomised trial of 27,000 US women in the 1990s, which revealed that oestrogen plus progesterone increased invasive breast cancer risk by 24% compared with placebo over six to seven years.

However, both studies used older HRT preparations that clinicians no longer prescribed, which limited their relevance to current patients, she said.

“Today, we use non-oral oestrogen, which we can prescribe as a patch or a gel, so we can use much, much lower doses.

“And we prefer to prescribe it with progesterone, which is not the synthetic progestogen. That may have very different effects. We really don’t know but … there are some data to suggest that these are much safer.”

The Lancet paper only addressed breast cancer risk, but “HRT is never unidimensional”,  Professor Davis said. “You might have a small increased risk of breast cancer maybe [from using HRT] but you also might have a profoundly reduced risk of fracture.”

HRT was also known to reduce the risk of cardiovascular disease and diabetes, so clinicians needed to carefully weigh the costs and benefits for the individual patient, Professor Davis said.

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Update on vaginal laser therapy

9 November 2018

MJA article Buttini Maher 5 Nov 2018

Earlier this week, Professor Chris Maher a urogynaecologist from the University of Queensland and Dr Melissa Buttini, a gynaecologist at the Wesley Hospital in Brisbane raised some serious questions about vaginal laser treatment of genitourinary syndrome of the menopause (GSM).

The Therapeutics Goods Administration (TGA) approved CO2 laser therapy for a number of body soft tissues, however was not listed specifically for treatment of GSM. There is no Medicare Benefits Schedule item number for CO2 laser therapy and so the extent of its use cannot be measured. We do know however that advertisements for CO2 laser therapy treatment for symptoms of GSM are extensive.

In July this year, the Food and Drug Administration (FDA) in the US issued a warning about the use of CO2 laser therapy for ‘vaginal rejuvenation’ and stated “These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.”

AMS President Clinical Associate Professor Amanda Vincent was interviewed for the Australian Doctor in response to the MJA article and noted “There are safety concerns and significant costs involved - the recommendation is for 3 treatments in a 12-month period with each treatment costing $500-$1000.”

Maher and Buttini question the abstract and conclusion of the first randomised control trial undertaken by Cruz et al reported in January this year. While Cruz et al suggest that vaginal laser therapy has a place in the treatment of GSM, further investigation of the methods and results paint a different story. Patients in the vaginal oestrogen intervention reported better outcomes compared with patients in the laser/sham cream arm who reported a significant worsening of pain.

In MJA InSight, Maher warns “What really causes some anxiety for me is we have been through all this within the past 10 years with transvaginal meshes, we’re still going through it.” Clearly further evidence is required from rigorous clinical trials before we can recommend vaginal laser as a therapy for GSM. In the interim, vaginal/topical oestrogen is the gold standard treatment for GSM as it is safe and efficacious. The only group of women who can’t use that are those with breast cancer or breast cancer survivors.

The AMS looks forward to hearing the results of a double-blinded, randomised, placebo-controlled trial of the efficacy of the MonaLisa Touch procedure for the treatment of postmenopausal vulvovaginal symptoms currently being undertaken by Professor Jason Abbott at the Royal Hospital for Women in Randwick.

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Obesity and vitamin D deficiency may indicate greater risk for breast cancer

Vitamin D is already well known for its benefits in building healthy bones. A new study supports the idea that it also may reduce cancer risk as well as breast cancer mortality, especially in women with a lower body mass index. 

Breast cancer remains the most common cancer in women worldwide and is the leading cause of death from cancer in women. Reproductive risk factors such as early onset of puberty, late menopause, later age at first pregnancy, never having been pregnant, obesity, and a family history have all been shown to be associated with breast cancer development. The role of vitamin D concentration in the development of breast cancer, however, continues to be debated.

This study involving more than 600 Brazilian women suggests that vitamin D may reduce cancer risk by inhibiting cell proliferation. Study results appear in the article "Low pretreatment serum concentration of vitamin D at breast cancer diagnosis in postmenopausal women."

Researchers involved in the study concluded that postmenopausal women had an increased risk of vitamin D deficiency at the time of their breast cancer diagnoses, associated with higher rates of obesity, than women of the same age group without cancer. Similar studies also have previously demonstrated a relationship between vitamin D and breast cancer mortality. Women in the highest quartile of vitamin D concentrations, in fact, had a 50% lower death rate from breast cancer than those in the lower quartile, suggesting that vitamin D levels should be restored to a normal range in all women with breast cancer.

"Although published literature is inconsistent about the benefits of vitamin D levels and breast cancer, this study and others suggest that higher levels of vitamin D in the body are associated with lowered breast cancer risk," says Dr. JoAnn Pinkerton, executive director of NAMS. "Vitamin D may play a role in controlling breast cancer cells or stopping them from growing. Vitamin D comes from direct sunlight exposure, vitamin D3 supplements, or foods rich in vitamin D."

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