| Label on Hormone Products To Reflect Concern on Risks By Marc Kaufman Washington Post Staff Writer Thursday, September 5, 2002; Page A02 The maker of the most popular hormone therapies for post-menopausal women has told doctors that there are possibly increased risks from all its estrogen-based products, and that their labels will now reflect that concern. The new company information will state that estrogen products should not be taken to prevent heart disease and should be taken for as short a time as possible. In addition, doctors were told to carefully consider alternatives to estrogen when trying to prevent osteoporosis in patients. The new labeling follows the conclusions from a large government study this summer that found potentially serious side effects from hormone replacement therapy. That study involved Prempro, a combination of the hormones estrogen and progestin, but the new labeling will apply to estrogen-only Premarin too. While the Women's Health Initiative (WHI) study of Prempro was halted due to increased incidence of heart disease and breast cancer, the arm of the study using Premarin was allowed to continue. "When we considered the implications of the study, we decided we wanted to apply the information to all the post-menopausal hormone therapies," said Victoria Kusiak, North American medical director for Wyeth Pharmaceuticals, the maker of the drugs. "The absence of data does not imply safety, and there's no way of telling from the study whether the risks were from the estrogen or the estrogen in combination with progestin." |
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