US FDA asks drugmakers to remove warnings from hormone therapy
Source: Reuters
(Reuters) -The U.S. Food and Drug Administration has initiated the removal of the agency's strictest "black box" warnings from hormone therapies given to women to treat menopause symptoms, according to the health regulator's website.
The FDA's decision follows a comprehensive review of scientific literature, an expert panel in July, and a public comment period.
The agency said it is working with drug manufacturers to update language in product labeling to remove references to risks of cardiovascular disease, breast cancer, and probable dementia.
Hormone replacement therapy for menopause replenishes the hormones, primarily estrogen, that decline with menopause to relieve symptoms like hot flashes and vaginal dryness.
Read more: https://www.yahoo.com/news/articles/us-fda-chief-makary-asks-155210161.html
FarPoint
(14,351 posts)BlueWaveNeverEnd
(12,160 posts)ananda
(33,991 posts)Do they need a reason except the abject need
to show cruelty through every action?
no_hypocrisy
(53,773 posts)for failure to warn of side effects?
DooverBeliever
(21 posts)For years now, it has been proven safe and actually helpful. Bio-identical hrt actually is shown to be helpful for heart, bones, brain. Do your research -- it is the TYPE of HRT, not HRT in general that could be harmful.
SomewhereInTheMiddle
(591 posts)... that they seem to have followed due process than anything else?
"The FDA's decision follows a comprehensive review of scientific literature, an expert panel in July, and a public comment period."
Did this somehow slip through the GOP/DOGE cracks or were the experts and public all supplied by the drug makers?