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Endocrine Society encourages clinicians to avoid prescribing compounded hormones

A new Scientific Statement issued by the Endocrine Society advises clinicians to avoid using compounded hormone medications to treat menopausal symptoms, female sexual dysfunction and other hormone conditions.

Sometimes called bioidentical compounded hormones, these products are typically a mixture of hormones. Compounded hormone medications are prepared by licensed professionals or facilities specifically for an individual's use. Compounded medications are meant to be an alternative when an individual does not have access to or has an adverse reaction to a medication approved by the U.S. Food & Drug Administration.

See comment from Australasian Menopause Society here

Compounded hormone medications can be unsafe when inappropriate practices are used. More than 60 people died from cases of fungal meningitis attributed to compounded medications in a 2010 case.

"In extreme cases, advertisers have marketed compounded products as being able to prevent the ravages of aging and implied they are risk free," said Nanette Santoro, MD, and the chair of the Society task force that developed the statement. "Few, if any, of these claims are supported by science."

Widely available hormone treatments that are 100 percent chemically identical to the native hormones found in the body and that are approved by the U.S. Food & Drug Administration (FDA) offer effective and safe options for people with hormone disorders, and those approved treatments should be prescribed whenever possible, Santoro said.

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FDA Approval of Flibanserin - Treating Hypoactive Sexual Desire Disorder

In a Perspective article in the New England Journal of Medicine the US Food and Drug Administration (FDA) offer an explanation regarding the approval Flibanserin. It opens as follows:

Was the Food and Drug Administration (FDA) approval of flibanserin (Addyi) for treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women long overdue? Or was it an error? In the face of divergent views, we at the FDA think it's important to clarify why flibanserin was approved after being rejected twice.

Read the full article here: http://www.nejm.org/doi/full/10.1056/NEJMp1513686#t=article

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HRT - more on risks and benefits

Two articles have appeared recently examining the risk benefit ratio of menopausal hormone replacement. The first, which constitutes Level 1a evidence, is a meta-analysis of 43 randomised controlled trials of HRT v placebo and effect on mortality [Benkhadra et al J Clin Endocrinol Metab 100: 4021–4028, 2015). This analysis found no effect on menopausal HRT overall on mortality. The authors’ conclusion is that current evidence suggests that HRT does not affect the risk of death from all causes, cardiac death and death from stroke or cancer. In 5 of the 43 trials, menopausal HRT was started at a younger age, i.e. less than 60 years or within 10 years of menopause. The meta-analysis of these 5 RCTs showed a reduction of mortality with HRT (RR 0.70 [95% CI 0.52–0.95]).

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Hormone replacement therapy may benefit the kidneys

Hormone replacement therapy may help protect kidney health, according to a study that will be presented at ASN Kidney Week 2015 November 3-8 in the US.

The effect of hormone replacement therapy on kidney function in postmenopausal women is unclear. To investigate, Andrea Kattah, MD, Vesna Garovic, MD (Mayo Clinic), and their colleagues studied 2217 postmenopausal women who participated in the Family Blood Pressure Program, a multi-network study aimed at analyzing the genetics of hypertension. A total of 673 women were taking hormone replacements and 1544 were not.

The researchers found that the prevalence of two markers of kidney disease - microalbuminuria and decreased estimated glomerular filtration rate - was significantly lower in women who were taking hormone replacement therapy as compared with women who were not. After adjusting for known risk factors for kidney and cardiovascular disease, the use of hormone replacement therapy remained significantly associated with lower levels of microalbuminuria.

"The risks and benefits of hormone replacement therapy in postmenopausal women are still an area of active debate, and the effect of hormone replacement therapy on the kidney has shown variable results," said Dr Kattah. "Clarifying the role of hormones on kidney function may have implications for explaining gender differences in chronic kidney disease, counseling women on the use of hormone replacement therapy, and future therapeutic targets for patients with chronic kidney disease," said Dr Kattah.

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'Natural' hormones hurting women - doctor

Dr Anna FentonNew Zealand's Dr Anna Fenton, Past President of the Australasian Menopause Society and co-editor in chief of the journal of the International Menopause Society, specialises in women's health, and says she sees at least one patient every day suffering side effects from dodgy hormone treatments.

Dr Fenton also said many doctors are seeing the same trend.

Listen to the interview on New Zealand Radio Nine to Noon

http://www.radionz.co.nz/national/programmes/ninetonoon/audio/201774902/dodgy-natural-hormone-treaments-making-women-sick

Read the article 'Natural' hormones hurting women - doctor

http://www.radionz.co.nz/news/national/287174/%27natural%27-hormones-hurting-women-doctor 

 

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Pharmacy Board of Australia has released new FAQs on the compounding of medicines

2 Mar 2015

The Pharmacy Board of Australia (the Board) has released new guidelines and other tools for registered pharmacists who compound medicines.

Pharmacists who regularly compound medicines are urged to read the:

  • Guidelines on compounding of medicines
  • Background on the regulation of compounding by pharmacists, and
  • Professional practice profile for pharmacists undertaking complex compounding.

The Guidelines on compounding of medicines were subject to wide-ranging consultation and will take effect on 28 April 2015.

The guidelines have been published now so pharmacists can become familiar with their content before implementation.

They replace Guideline 5 Extemporaneous dispensing (compounding) from the Board's Guidelines for dispensing of medicines published on 12 August 2010.

Board Chair, Adjunct Associate Professor Stephen Marty, said the intent of the new guidelines is to provide detailed guidance to pharmacists who compound medicines to ensure product quality, safety and efficacy.

Additionally, the new guidelines provide guidance on compounding medicines of a more complex nature ('complex compounding') which requires or involves specific competencies, equipment, processes and/or facilities to manage the higher risks associated with the preparation and dispensing of these medicines.

'A significant enhancement of the original guidelines, the guidance released today aims to minimise the associated risks for patients, pharmacists and other pharmacy staff,' he said.

'Improved patient outcomes and patient safety is also an aim and expectation.'

Two other tools now released are the:

  1. Background on the regulation of compounding by pharmacists a.Contains information on the requirements of other authorities under their specific legislation, which relate to compounding. Each jurisdiction has separate requirements which may be specified in legislation and guidelines for these purposes.
  2. Professional practice profile for pharmacists undertaking complex compounding a.Outlines the required competencies of pharmacists undertaking complex compounding. It can assist pharmacists to acquire and maintain the required competence for any type of complex compounding and can also be used by course providers to develop training programs.

The circumstances under which pharmacists may compound and supply extemporaneously prepared medicines in and from different types of premises, or require a manufacturing licence from the Therapeutic Goods Administration (TGA), can be accessed on the Therapeutic Goods Administration website.

The TGA is in the final stages of consultation about possible changes to the regulation of compounded medicines. The Board will further consider its guidance upon publication of a revised legal framework by the TGA to ensure that it is aligned with any new requirements and continues to provide protection of the public.

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Short-term use of hormone replacement therapy (HRT) and ovarian cancer risk

hormone replacement therapyA meta-analysis of 52 epidemiological studies, involving a total of 21488 women with ovarian cancer, almost all from North America, Europe and Australia, was published in The Lancet on 13 February 2015 (see About the study). The findings from the study suggest that taking hormone replacement therapy (HRT) for the menopause, even for just a few years, is associated with an increased risk of developing ovarian cancer.


Comment from AMS

Dr Anna FentonDr Anna Fenton BHB, MBChB, PhD, FRACP
AMS President

"This recent meta-analysis from the Collaborative Group raises the possibility of an increased risk of ovarian cancer with use of estrogen or combined estrogen-progestogen therapy.

The data is heavily influenced by the Million Women Study which is widely acknowledged to have significant flaws. There has been no correction for the BMI of the women, their previous use of the contraceptive pill or age at menopause.

In the days since the study was released examination of the relative and absolute risk calculations have shown them to be incorrect. The revised absolute risk increase appears to now sit at just under 1 extra case per 10,000 women per year; somewhat less than the study initially suggested.  

Ovarian cancer is a rare condition but all the risks and benefits of hormone therapy need to be carefully considered when treating women at menopause.

Women should not stop hormone therapy based on this study but if they are concerned they should discuss the findings with their doctor." 

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Women play dangerous waiting game with heart symptoms

Heart disease a leading cause of death for women yet they are more likely than men to dismiss pain and delay seeking medical help

When heart symptoms strike, men and women go through similar stages of pain but women are more likely to delay seeking care and can put their health at risk, according to a study presented at the Canadian Cardiovascular Congress.

"The main danger is that when someone comes to the hospital with a more severe or advanced stage of heart disease, there are simply fewer treatment options available," says Dr. Catherine Kreatsoulas, lead author of the study and a Fulbright Scholar and Heart and Stroke Foundation Research Fellow at the Harvard School of Public Health.

Dr. Kreatsoulas, an epidemiologist, says we don't know enough about how people perceive their heart symptoms and at what stage they are prompted to seek medical care. Her study included patients with suspected coronary artery disease, just prior to undergoing their first coronary angiogram test.

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Coping with change revisited

hot flashesSometimes a "natural part of life" needs a little bit of expert knowledge and understanding to better cope with changes. In the Washington Post article Treating menopausal symptoms: What you need to know by Janice Lynch Schuster on October 13 2014, she contrasts her activities surrounding understanding the onset of menstruation with her unpreparedness for the changes of menopause.

Some key comments in the article show the consequences of the Women’s Health Initiative (For more information see Women’s Health Initiative Update 2013) where the conclusions drawn back in 2002 led to an 80% drop in hormone therapy prescriptions worldwide(1).

From Treating menopausal symptoms: What you need to know 

...The more current analyses of the Women’s Health Initiative data, along with other recent studies, indicate that for women in their 50s, just entering menopause, HT is a relatively safe treatment that can be used for up to five years and is not associated with an increased risk of heart disease (although women should still be screened and treated for risk factors, such as high blood pressure and breast cancer)...

...Richard J. Santen, president of the Endocrine Society, says that following the 2002 findings from the Women’s Health Initiative, which indicated that hormone therapy was harming women, prescriptions for it fell by 80 percent worldwide. At the same time, he says, medical training programs began to overlook training new doctors how to care for menopausal women...

...“For someone who has been debilitated by symptoms, you need to find a doctor who will really talk to you and listen to your concerns. The doctor should assess your risk factors and understand the benefits and risks you face. Right now, people just don’t know enough about the data, and it is easier for doctors not to prescribe at all,” Chang says...

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Soy may help women's hearts if they start early

A diet rich in soy may help feminine hearts, but timing matters, finds a new study published online Menopause, the journal of The North American Menopause Society.

Lifelong soy consumption, similar to the diet of women in Asia, produces the least atherosclerosis. Switching to a Western diet after menopause, similar to Asian migrants to North America, leads to just as much atherosclerosis as a lifelong Western diet, and switching to soy from a Western diet after menopause helps only if there isn't much atherosclerosis already.

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