WEDNESDAY, Jan. 8, 2003 (HealthDayNews) -- The Food and Drug Administration is ordering warning labels for the hormone replacement therapy products used by more than 6 million American women and will urge doctors to limit their use as much as possible.
The action comes as no surprise. It is based on the FDA's analysis of the Women's Health Initiative, a major study that was canceled last year when a review found that the health risks of hormone replacement therapy (HRT) outweighed the benefits.
Wyeth Pharmaceuticals, which markets Prempro, Premphase, and Premarin, three of the most widely used HRT products, has already agreed to put the warning labels on its products. And other manufacturers are being told to do the same, said Dr. Florence Houn, director of the FDA's Center for Drug Evaluation and Research, who made the announcement.
Each product will have a boxed warning, patient information leaflets are being revised, and "women need to talk to their physicians about whether treatment with these products is necessary," Houn says.
The boxed warning will say that "estrogens with or without progestins should not be used for the prevention of cardiovascular disease." It will also say that an increase in risk of heart attacks, strokes, invasive breast cancer, and blood clots in the lungs or legs was found for HRT users in the Women's Health Initiative study.
In a statement, Dr. Victoria Kusiak, vice president of global medical affairs for Wyeth, said, "We believe it is in the best interests of patients and physicians that all manufacturers of hormone therapy products act quickly to modify their prescribing information."
Other manufacturers are being given 60 days to revise their labeling, Houn says. "Many companies have been waiting for the FDA's suggestions, and they are eager to incorporate the findings of the Women's Health Initiative to insure that their labels are accurate," she said.
A report last July said that participants in the Women's Health Initiative who took HRT products experienced a 29 percent increased rate of coronary heart disease problems, compared to women taking a placebo. The incidence of strokes was 41 percent higher, the rate of blood clots doubled, invasive breast cancer levels were 26 percent higher, and total cardiovascular disease increased by 22 percent.
Those ill effects more than offset the 37 percent decrease in colorectal cancer, 33 percent reduction in hip fractures, and 24 percent decrease in all fractures, the report said.
HRT products now are prescribed for three reasons, Houn said: to reduce moderate-to-severe cardiovascular symptoms (such as night sweats); to prevent vulvar and vaginal atrophy; and to prevent osteoporosis. In two of the three cases, the FDA labeling will advise limiting the use of HRT.
The indications for cardiovascular syndrome will remain the same, said Houn. For moderate-to-mild cases of vulvar and vaginal atrophy, topical medications -- those applied to the affected area -- should be considered. And "only women at significant risk of osteoporosis" should consider HRT, with nonestrogen products used whenever possible, she said.
For HRT, "the lowest dose for the shortest possible time should be used," Houn said.
The agency will urge further studies of HRT by companies, professional societies and other researchers, Houn said.
What To Do
Further information on the labeling changes is offered by the Food and Drug Administration. To learn more about the HRT study, visit the Women's Health Initiative.
