According to FDA Commissioner Dr. Marty Macri, who is considered a long-time supporter of hormone therapy, the new wording of the leaflets will include age-adjusted guidelines, with an emphasis on the fact that starting treatment within ten years of the onset of menopause may bring significant health benefits. According to him, hormone therapy may reduce the risk of heart disease, cognitive decline, and bone loss. “The long-term benefits of the treatment have been misunderstood For years,” said Macri, who claimed that this is one of the most important health interventions for women, “perhaps with the exception of antibiotics and vaccines.”
The FDA’s decision provokes a sharp debate in the medical community. Dr. Diana Zuckerman, president of the National Center for Health Research in the United States, claimed that this is a dangerous move that will set women’s health back. “Removing the black box and transferring the warnings to a long leaflet that most doctors and patients will not read is an irresponsible step,” she said. According to her, the claim that hormones are the best way to improve women’s health contradicts decades of research.
Historically, hormonal treatments have been used by menopausal women since the 1940s, mainly to alleviate symptoms such as hot flashes, night sweats and insomnia. From the 1980s, doctors began to recommend them also to prevent heart disease and calcium loss. But large studies commissioned by the American government in the early 2000s, including the well-known WHI study, indicated an increased risk of stroke, blood clots and breast cancer among women treated with a combination of estrogen and progestin. Following this, the medical guidelines were reduced and it was recommended to use hormones only for a short period and in the lowest possible dose.
However, in recent years the scientific debate surrounding the findings of those studies has been increasing. Experts claim that some of the test subjects were too old to benefit from the protective effects of the hormones, and that treatment that begins close to menopause may actually reduce risks. Some doctors also emphasized the differences between oral preparations and topical preparations (such as creams or vaginal suppositories), which, according to them, are almost never absorbed into the bloodstream and therefore carry a much lower risk.
In practice, the use of hormone therapy has decreased dramatically in recent decades. Although estrogen is still considered the most effective treatment against menopausal symptoms, many women who can benefit from it choose to avoid it due to the fear of side effects. This is despite the fact that in recent years, non-hormonal treatments have also entered the market, such as the drug Veozah, approved by the FDA for the treatment of hot flashes by regulating nerve activity in the brain.
According to the current guidelines, the hormonal drugs carry a warning that taking estrogen, with or without progestin, may increase the risk of stroke, blood clots and dementia in women over the age of 65, as well as increase the risk of breast cancer in combination with the hormones. However, it was already stated in the current bulletin that the findings concern only certain formulas, and that these risks are not necessarily relevant to local preparations or low doses.
The new guidelines are expected to change the way doctors will recommend hormone therapy around the world, although health officials in Israel estimate that the local impact will be more moderate, since there is already a careful and personalized approach to menopause treatment.