IF YOU HEARD THE HRT NEWS
Heard the HRT warning changed? What's new
Three risk references are coming off labels. One boxed warning stays. Here is the split.
What is coming off
Three risk references are going
- Cardiovascular disease, breast cancer and probable dementia references are being removed from labels
- The FDA says it is working with companies on the new label language
- It followed a literature review, an expert panel and public comments
What is staying
One boxed warning is not going
The FDA says the endometrial cancer boxed warning stays for systemic, estrogen-alone products.
Why the old warnings existed
They followed a Women's Health Initiative study
Boxed warnings were applied in the early 2000s, after a Women's Health Initiative study. Participants averaged 63 years old and took a formulation no longer in common use.
Timing on the label
The FDA also names a window
- The FDA says its label will recommend starting systemic HRT within 10 years of menopause onset or before age 60
- It also says start time and length of use are decided between prescriber and patient
Bring this to your appointment
Questions for your doctor
- How does the label change apply to the type of HRT I use or am considering?
- Does my timing since menopause matter for my options?
- Does the endometrial cancer warning apply to me?
As slides
Sources
General information, not medical advice.