BodyLogicMD, a provider of bioidentical hormone replacement therapy (BHRT), integrative medicine and weight loss treatment, said on Friday that it completely supports the recommendation to remove black box warnings on certain forms of oestrogen used to treat menopause symptoms.
Data from an old government study on women's health, known as the Women's Health initiative (WHI), led to conclusions that hormone therapy was linked to an increased risk of several conditions, including breast cancer, heart disease and potentially dementia. The average age of women in the study was 63 years old, a decade beyond the age of most women wanting to start hormone therapy, BodyLogicMD noted. Additionally, the hormone therapy used in the study was artificial and proven to be a substandard form of hormone therapy.
The black box warning was added to labels in 2003 by the US Food and Drug Administration (FDA) to warn of potential health risks associated with oestrogen hormone therapy.
"BodyLogicMD has over 20 years of science-based experience treating thousands of women suffering from menopause and perimenopause," commented Jennifer Landa, MD, chief medical officer at BodyLogicMD. "After extensive research and review of clinical data, experts have found that these risks are overstated and do not apply to all forms of oestrogen. In fact, oestrogen has been shown to reduce fractures, dementia, heart disease and death for any reason in women who start therapy in the first decade after menopause."
Landa added: "The FDA black box warning has caused confusion among menopausal women and healthcare providers about the safety and efficacy of these menopause treatments. It has prevented many women from seeking treatment for their menopause symptoms such as hot flashes, mood swings and sleep disturbances. This decision is potentially life changing for women."
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