The change is symbolic but major: the Food and Drug Administration (FDA) has decided to remove the boxed warning (the most severe on its scale) from the packaging of more than twenty hormonal treatments. These are used to relieve symptoms of menopause, such as hot flashes, night sweats or trouble sleeping. These medications contain estrogen and progesterone, in the form of tablets, patches or creams. Until now, they carried a black box warning of an increased risk of stroke, heart attack, dementia or even breast cancer. So it’s over.
Why such a turnaround?
It all dates back to the early 2000s. A large American study of more than 26,000 women then highlighted an increased risk of clots, heart disease and breast cancer among users of certain hormonal treatments. These results caused global panic and a collapse in prescriptions.
But the most recent, refined studies show that hormone therapy is safe when started before age 60 or within ten years of menopause, a period during which the benefits far outweigh the risks.
The FDA now believes that these warnings were too alarmist and outdated. “This is more nuanced, evidence-based communication”explains today the agency’s commissioner, Marty Makary, in the Journal of the American Medical Association.
Furthermore, the formulations have evolved. Vaginal gels, creams and rings now deliver smaller, more localized doses than oral tablets, reducing side effects.
And in France? “We’ve known it for a long time“, replies Dr. Bagot
In France, this announcement does not create a revolution in the medical field. As Dr. Odile Bagot, gynecologist, recalls, ““We have long since adopted a much more balanced approach.”.
“In our country, we have known for a long time that bioidentical estrogens administered transcutaneously do not increase cardiovascular risk, provided that they are prescribed in the first five years after menopause”she specifies.
Cardiovascular restrictions exist, but according to the expert, caution is only necessary in women at risk:
“A woman who has a history of vascular or cardiac disease must benefit from a real assessment before starting treatment. This is not trivial, but if indicated, it can be very beneficial.”
Clearly, France did not wait for the United States to qualify its discourse on hormone therapy.
“What makes me smile, adds Dr. Bagotis that it has been said for years that hormonal treatment can be prescribed without danger in most cases. But the FDA had to give the green light for the rest of the world to finally believe us!”
Safe treatments, provided they are used correctly
Today, French and European recommendations converge:
- Start treatment early, ideally before age 60;
- Use bioidentical hormones, identical to those produced naturally;
- Favor the transdermal route (patch, gel) to avoid the risk of thrombosis;
- Associate micronized progesterone, better tolerated and not linked to an increased risk of breast cancer.
“When we use the right combination, bioidentical estrogens and micronized progesterone, we do not increase the risk of breast cancer or meningioma”insists Dr. Bagot.
However, hormonal therapy is not recommended for women who have:
- Personal history of breast cancer;
- Thrombosis or pulmonary embolism;
- Proven cardiovascular disease.
But for Dr Bagot, the American decision is an encouraging signal to restore women’s confidence. “What the FDA is doing is catching up. In Europe, we already have this pragmatic approach: prescribing to women who need it, at the right time, without feeling guilty or being overly cautious.”