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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]).

Read more: HRT - more on risks and benefits