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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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Hormones may help younger women with menopause symptoms

From Endocrine Daily: "Shots" blog

A closer analysis of the 2002 Women’s Health Initiative findings, which previously suggested that women taking “estrogen plus progestin hormone replacement therapy” were at an increased risk “of heart disease and breast cancer,” revealed that age “really made a difference in heart disease risk.”

The analysis revealed that women between the ages of 50 and 59 actually had a protective benefit to using HRT, while women over 60 did not have the same advantage.

However, regardless of age, studies did confirm a small “increased risk of breast cancer among women taking hormones.”

Lead investigator Dr JoAnn Manson explained, “For every 1,000 women per year not using hormone therapy, about three would develop breast cancer,” compared to four out of “every 1,000 women using hormone therapy” who may “develop breast cancer.” 

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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


Read the article 'Natural' 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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A cautionary tale: Very high systemic androgen levels

This reflects the sometimes very high systemic androgen levels can be achieved with vaginal androgen therapy.

Effect of Topical Vaginal Androgens in a Woman on the Testosterone Levels of Her Sexual Partner With Prostate Cancer

We present the unusual case of a gentleman with prostate cancer with known biochemical recurrence after failure of local therapy, in which we found increasing levels of serum testosterone above the normal range, consistent with exogenous receipt of androgens. The patient denied the use of androgens, and we discovered that his persistently high testosterone levels were due to the application of topical testosterone cream applied intravaginally by his wife...

...In summary, patients with prostate cancer with elevated testosterone levels should be investigated for use of topical androgens taken either by themselves or by their sexual partners. This exogenous androgen could stimulate the growth of the prostate cancer leading to adverse outcomes.

See the full letter to the Editor at http://jco.ascopubs.org/content/33/5/521


Al-Marrawi MY, Cream LV, Mallon CA, Holder S, Joshi M, Harvey HH, Talamo G, Drabick JJ. Effect of topical vaginal androgens in a woman on the testosterone levels of her sexual partner with prostate cancer. J Clin Oncol. 2015 Feb 10;33(5):521-2. doi: 10.1200/JCO.2014.59.7773. Epub 2015 Jan 5.

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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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NAMS to launch free menopause mobile app

New dual-mode clinical decision-support tool uses one-of-a-kind algorithm to help clinicians and patients work together to personalize treatment decisions

The North American Menopause Society (NAMS) is set to launch a first-ever menopause mobile app designed for use by both clinicians and patients to help manage menopausal symptoms and assess risk factors.

Among its many unique features, the new app (MenoPro) offers two modes (one for health care providers and the other for patients) and allows users to access outstanding NAMS resources and an internal cardiovascular disease (CVD) risk score calculator as well as offering the ability to email a summary of the decision-making process and information pages/handouts to the patient.

"This new app represents a major step forward for both clinicians and patients looking to make more informed health care decisions," says JoAnn Manson, MD, NAMS scientific program chair and lead author of the article published October 15 in Menopause, the NAMS scientific journal, entitled "Algorithm and Mobile App for Menopausal Symptom Management and Hormonal/Non-hormonal Therapy Decision Making: A Clinical Decision-Support Tool from The North American Menopause Society". According to Dr Manson, who is also a past president of NAMS, the new iPhone/iPad app is expected to revolutionize the management of menopausal symptoms and use the most recent science to help clinicians decide which patients are candidates for pharmacologic treatment and to personalize their care.

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