FDA drops black-box warnings from three more estrogen menopause patches
Three estrogen patches for menopause will lose their strictest black-box warnings, federal health officials said on Friday. The FDA did not ask its outside advisers first. Officials say they will share the evidence later, and a Yale expert says they have not been open about it.
Three estrogen patches used to treat menopause will no longer carry black-box warnings, federal health officials said on Friday. These are the strictest warnings on a drug label. The patches deliver estradiol, a form of estrogen, through the skin. The Guardian and Reuters reported the change. Reuters said the Department of Health and Human Services did not answer its request for the brand names.
The warnings had flagged risks of cardiovascular disease, breast cancer and dementia, the Guardian said. In its release, the Department of Health and Human Services said the changes reflect "a thorough re-examination of the scientific literature." FDA official Sarah Ibrahim said they "painted a broad and, in some cases, overstated pictures of risk." She said that for many healthy women under 60, and within 10 years of menopause, newer evidence shows a different balance of risks and benefits.
The FDA did not call an advisory committee before the decision, the Guardian reported. It said officials gave few details on the science at a press briefing. When reporters asked for the evidence, officials said it could be provided later. Six other menopause treatments lost the warnings in February, the Guardian said.
"I have been concerned by the lack of transparency behind these decisions," said Reshma Ramachandran, a researcher at the Yale School of Medicine. She said removing the warnings without clear reasons "can be misleading for patients and underplays real potential harms."
Officials also spoke about shortages. Many women have struggled to find patches as demand surged, Reuters said. Ibrahim said demand rose sharply after the February label change. "We know that for some patients, these past months have been frustrating," she said. The FDA is working with makers to boost supply, officials said. The Guardian said the agency is also looking at selling vaginal estrogen products over the counter.
What we know: Three estradiol patches are losing their black-box warnings, and the FDA did not consult its advisers first.
What we don't: Which brands are affected, and what evidence the FDA used.
Where outlets agree The cited reports agree federal health officials said on Friday that three estrogen patches for menopause will lose their black-box warnings.
Where they differ The cited reports agree on the key facts so far.