FDA to Reassess the Risks of Hormone Therapy
Federal officials announced Tuesday that they have begun a major reassessment of the risks and benefits of all combination hormone products containing estrogen used by post-menopausal women, one month after a large government study found potentially serious side effects from hormone replacement therapy.
The reassessment, which will include several public forums this fall sponsored by the National Institutes of Health, the Food and Drug Administration and the Agency for Healthcare Research and Quality will also try to guide future research.
The move marks the first significant action by the federal government in response to the latest findings about hormone therapy. It is designed to address the widespread confusion that has caused anxious women to inundate doctors with questions about whether they should continue taking the powerful hormones.
“Somebody needed to take a leadership role, because there is chaos in the medical societies,” said Wulf H. Utian, executive director of the North American Menopause Society, who has been invited to participate in the meetings. “It’s time to clear the air and address the issues.”
The brief announcement of the initiative came as the FDA separately pushed for immediate changes in the label and the package insert for the hormone combination sold as Prempro to reflect the risks confirmed by the Women’s Health Initiative.
Part of that federally funded study was stopped three years early because of small but statistically significant increases in heart disease, breast cancer, stroke and blood clots among women taking Prempro, a combined estrogen-progestin drug. Although the study used only Prempro, agency officials said they have new questions about other estrogen-progestin products on the market.
In response to the immediate FDA concerns, officials at Wyeth Pharmaceuticals, maker of Prempro, said the company expects to submit new safety precaution information as early as this week that will take into account the Women’s Health Initiative findings. The initiative’s study tested the widely held hypothesis that hormone therapy reduced the risk for heart disease in particular and, so, was especially surprising.
These initial steps can be taken without formal FDA approval. But officials said that they are aggressively reviewing hormone replacement therapy generally--now used by 14 million American women--and that more wide-ranging changes can be expected.
