FDA removes black box warning from menopause hormone therapy

The FDA, the US regulatory agency, has removed the most severe warning from labels of hormone therapy for menopause. This change revises 2003 alerts about cardiovascular and cancer risks. In Brazil, the move underscores the need for more information and medical training on the issue.

The week was filled with calls to 'save the planet', but it started with rare good news for women's health: the FDA removed the 'black box' — the agency's most severe warning — from labels of hormone therapy for menopause.

It's worth recalling the background. In 2003, a large study, conducted without adequate criteria, led to warnings about increased risks of heart attacks, strokes, thrombosis, and breast cancer linked to hormones. Now, the axis shifts: if started up to ten years after menopause, the therapy can bring long-term benefits, with well-defined contraindications and no promises of miracles. This is an important revision of the label and approach.

Over 15 years as a health journalist, Folha columnist Mariliz Pereira Jorge has seen menopause treated as a footnote. This American decision sheds light on Brazil, where hormone replacement faces two key issues: lack of information and specific training for doctors. Women often wander from one office to another until finding a qualified professional for comprehensive evaluations that go beyond personal and family history, covering sleep, mood, bones, heart, skin, vagina, work, and life.

Not everything is for everyone. The good news is that the debate is moving beyond 'all or nothing'. The author celebrates a 'small thaw in the climacteric', starting with information, autonomy, and choice. She adds a personal footnote: she officially enters menopause in two months and, on bad days, feels like 'an old dishcloth', which is untenable for any active woman.

Hormone therapy is neither villain nor miracle. When menopause is taken seriously, everyone wins: the woman, the family, work, the economy, society. 'It doesn't help to save the cities, the whales, and the trees if we don't save the women', the columnist concludes.

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