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Revising the Guidelines for Hormone Replacement Therapy -- Again

Labels must warn of dementia risk for older women

FRIDAY, Feb. 13, 2004 (HealthDayNews) -- For the second time in two years, U.S. officials are calling on drug makers to update the labels on hormone therapy products to reflect the most recent health warning. And this probably won't be the last time labels are changed.

Susan F. Wood, assistant commissioner for women's health at the U.S. Food and Drug Administration, says the first changes were called for about a year ago, to incorporate data from the hormone therapy arm of the Women's Health Initiative (WHI) trial.

That trial was unexpectedly halted in the summer of 2002 when it was found that the combination of progestin and estrogen apparently increased the risk of heart attacks, heart disease and breast cancer. Although women on the hormone therapy had a lower risk of colorectal cancer and of fractures related to osteoporosis, researchers concluded those benefits did not outweigh the risks.

Then last May, the Women's Health Initiative Memory Study (WHIMS) reported more bad news: An increased risk of dementia in women 65 and over taking the combined hormone therapy. It was unclear, however, if this would be true for younger women as well. Combination therapy also failed to prevent memory loss.

As more details on hormone replacement therapy (HRT) come in, more label revisions can be expected.

"We have revised it yet again, and I can't say it won't happen again as we get new data," Wood says.

Dr. Victor Henderson is a member of the board of trustees of the North American Menopause Society. He says, "I think from large studies like this (WHI), it's not uncommon for the FDA to recommend labeling changes when it thinks the evidence is strong enough and the health implications are real."

"It doesn't hurt to have something like this formalized," adds Henderson, a professor of geriatrics and neurology at the University of Arkansas for Medical Sciences Center on Aging.

Wood says that while the FDA's latest action is "guidance," not a regulation, "there will be label changes." Actual label changes involve give-and-take between the individual drug makers and the FDA and take time.

"It's usually something that occurs over a period of months," Wood explains. And changes will not apply to products already on the shelf, only to new products coming out.

Among other things, the guidance indicates that manufacturers should include the latest WHIMS dementia data in the existing "Black Box" warning, which contains information on risks. Manufacturers also must specify the lowest effective dose, or the fact that the lowest dose has not yet been determined.

"[Now] we say there's no evidence it will help you with memory or Alzheimer's," Wood says. "That was sort of a neutral stance. We may revise that a bit."

In general, the FDA's stance is that women requiring hormone therapy should be on it at the lowest possible dose for the shortest time needed.

Theoretically, most of this new information on dementia has been incorporated into clinical practice already.

"I explain the study findings to my patients," Henderson says. "I say, based on the information we have to date, the assumption is that hormone therapy, particularly estrogen plus progestin, shouldn't be used to prevent dementia. The data is primarily for older women but, for now, I would make the same recommendation for someone who's younger."

Wood adds: "I think we all have to realize that we're at a time when more information is coming out all the time. The focus on research on women's health led to WHI and others which are now bearing fruit. We might say we should have had them 20 years ago, but we didn't. But now we do and that in and of itself is a good thing. We just have to be willing to accept all the change as well."

More information

For more on the Women's Health Initiative, visit the National Institutes of Health. The U.S. Food and Drug Administration has more on menopause and hormones.

SOURCES: Victor W. Henderson, M.D., member, board of trustees, North American Menopause Society, professor, geriatrics and neurology, University of Arkansas for Medical Sciences Center on Aging, Little Rock, and associate chief of staff, geriatrics and extended care, Central Arkansas Veterans Healthcare System; Susan F. Wood, assistant commissioner, women's health, U.S. Food and Drug Administration, Rockville, Md.
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