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INTERVIEW: FDA removes warning labels on Menopause Hormone Therapy

INTERVIEW: FDA removes warning labels on Menopause Hormone Therapy
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WEST MICHIGAN — Menopause is the term to describe women no longer receiving natural estrogen from her ovaries, and for several years, women who would be excellent candidates for Menopause Hormone Therapy did not take the medication because of inappropriate fear.

Dr. Diana Bitner with True Women's Health says a fear of MHT could have come from an ill-informed healthcare provider, or because they were too afraid to take their provider's advice.

The FDA is requesting that drug companies make moves to change the label removing the black box warning on MHT medication warning of the risk of CVD, cancer, and dementia. The FDA is asking companies to provide language supported by current literature differentiating benefits and risks by age and time from the beginning of menopause.

Dr. Bitner says the move to change labelling is good, as previous labels were based on a study called the WHI. Bitner says the results of the WHI were wrongly released to media, and reflected results from women that were at the average age of 63 and more than 10 years into menopause, no longer having symptoms of it. As companies are allowed to rewrite labels based on current scientific data, healthcare providers will be supported in providing better informed consent.

MHT is not for all women, Dr. Bitner says, for factors including having an estrogen sensitive cancer, or aprogressed heart disease. The FDA recently made a move to approve a novel NKT that works on the thermostat just like estrogen, and is indicated to treat the hot flashes and night sweats of menopause, benefitting sleep patterns.

Dr. Bitner says it's important to get the facts straight, and to make sure you have a healthcare provider that gives you balanced discussion about therapy for any condition, especially a life-changing condition like menopause.

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