Max
08-14-2002, 02:24 PM
US Officials to Reassess Value of Hormone Therapy
Wed Aug 14, 1:23 PM ET
By Ori Twersky
WASHINGTON (Reuters Health) - US healthcare officials are planning to reassess the benefits of estrogen-containing hormone replacement products in response to a recently halted study that unveiled potentially serious side effects in postmenopausal women.
Performed as part of the US government-sponsored Women's Health Initiative (WHI), the study was halted 3 years earlier than expected because of emerging evidence showing a small yet statistically significant increase in the risk of heart disease, breast cancer ( news - web sites), stroke and blood clots.
In that study, women were taking Prempro, a combination of estrogen and progestin. An estrogen-only drug, Premarin, is being evaluated in a second branch of the WHI in women without a uterus. That study is ongoing and results are not yet available.
It is not yet clear if the WHI results also apply to lower doses of Prempro, or different combinations of estrogen and progestin, according to the US Food and Drug Administration ( news - web sites) (FDA).
Government officials said the reassessment would begin with several public forums to be held this fall and would be led by the National Institutes of Health ( news - web sites), the FDA, and the Agency for Healthcare Research and Quality.
"Consideration will be given to the extent to which the WHI results might be extrapolated to other combination estrogen/progestin products and doses, an assessment of known benefits for approved indications in the light of these new data, and the WHI's implications for future clinical trials of hormonal therapy," according to the FDA.
"Our collective goal is to keep the public informed so that doctors and patients can make sound decisions about use of hormonal products. Ultimately there may need to be additional research to answer some questions, but until there is a full review of the WHI data, what that would entail can't be determined," an FDA spokesperson said.
The brief announcement made on Tuesday followed a separate announcement by the FDA that it would also push for immediate revisions to the label of drugmaker Wyeth's Prempro.
The FDA said the immediate revisions would center on incorporating the study results on the drug's label.
But the larger federal effort could lead to greater changes in how such combination drugs are prescribed for millions of women.
Federal officials said among their goals was to determine if menopause is even a condition that merits treatment.
FDA officials added that the government-approved label for these drugs eventually could be altered to recommend limited treatment for a limited amount of time as well as to carry a black-box warning to warn about the side effects.
The FDA is expected to pose these questions before an expert advisory committee this fall or winter for independent evaluation.
Similar debates concerning how these drugs might now be used and prescribed are also ongoing among professional organizations such as the American College of Obstetricians and Gynecologists.
The current recommendation is that women should discuss their individual situation with their physician until a consensus opinion can be formulated.
In the meantime, drugmaker Wyeth has promised to cease advertising its drug directly to consumers.
The Madison, New Jersey-based drugmaker has also said that it would increase visits to physicians to outline and explain the results of the landmark study.
Wed Aug 14, 1:23 PM ET
By Ori Twersky
WASHINGTON (Reuters Health) - US healthcare officials are planning to reassess the benefits of estrogen-containing hormone replacement products in response to a recently halted study that unveiled potentially serious side effects in postmenopausal women.
Performed as part of the US government-sponsored Women's Health Initiative (WHI), the study was halted 3 years earlier than expected because of emerging evidence showing a small yet statistically significant increase in the risk of heart disease, breast cancer ( news - web sites), stroke and blood clots.
In that study, women were taking Prempro, a combination of estrogen and progestin. An estrogen-only drug, Premarin, is being evaluated in a second branch of the WHI in women without a uterus. That study is ongoing and results are not yet available.
It is not yet clear if the WHI results also apply to lower doses of Prempro, or different combinations of estrogen and progestin, according to the US Food and Drug Administration ( news - web sites) (FDA).
Government officials said the reassessment would begin with several public forums to be held this fall and would be led by the National Institutes of Health ( news - web sites), the FDA, and the Agency for Healthcare Research and Quality.
"Consideration will be given to the extent to which the WHI results might be extrapolated to other combination estrogen/progestin products and doses, an assessment of known benefits for approved indications in the light of these new data, and the WHI's implications for future clinical trials of hormonal therapy," according to the FDA.
"Our collective goal is to keep the public informed so that doctors and patients can make sound decisions about use of hormonal products. Ultimately there may need to be additional research to answer some questions, but until there is a full review of the WHI data, what that would entail can't be determined," an FDA spokesperson said.
The brief announcement made on Tuesday followed a separate announcement by the FDA that it would also push for immediate revisions to the label of drugmaker Wyeth's Prempro.
The FDA said the immediate revisions would center on incorporating the study results on the drug's label.
But the larger federal effort could lead to greater changes in how such combination drugs are prescribed for millions of women.
Federal officials said among their goals was to determine if menopause is even a condition that merits treatment.
FDA officials added that the government-approved label for these drugs eventually could be altered to recommend limited treatment for a limited amount of time as well as to carry a black-box warning to warn about the side effects.
The FDA is expected to pose these questions before an expert advisory committee this fall or winter for independent evaluation.
Similar debates concerning how these drugs might now be used and prescribed are also ongoing among professional organizations such as the American College of Obstetricians and Gynecologists.
The current recommendation is that women should discuss their individual situation with their physician until a consensus opinion can be formulated.
In the meantime, drugmaker Wyeth has promised to cease advertising its drug directly to consumers.
The Madison, New Jersey-based drugmaker has also said that it would increase visits to physicians to outline and explain the results of the landmark study.