Federal Officials To Review Treatment, Marketing of Hormone Replacement Therapy
To address the "widespread confusion" surrounding hormone replacement therapy, federal officials yesterday announced that they have started a "major reassessment" of the benefits and risks of all products containing estrogen that are used by post-menopausal women, the Washington Post reports. The effort is the first "significant action" taken by federal officials since a government study was terminated early because of findings that HRT may cause "potentially serious side effects" (Kaufman, Washington Post, 8/14). Part of the Women's Health Initiative ended three years ahead of schedule last month because researchers determined that HRT carries a "slight but significant" increase in the risk of invasive breast cancer and other diseases (California Healthline, 7/10). The Post reports that the government review may affect the recommendations on who should use HRT, what doses should be prescribed and how long treatment should last. In addition to reviewing HRT "in general," federal officials will investigate whether HRT producers have encouraged women to consider menopause "a condition to be treated," rather than a natural occurrence "to be managed," the Post reports. As part of the effort, the NIH, FDA and Agency for Health Care Research and Quality will sponsor several public forums on the issue. The agencies will also attempt to guide future HRT research. The FDA expects to hold an expert advisory meeting this year to make recommendations on how hormone therapies should be prescribed. The advisory committee will also consider requiring estrogen-combination product labels to have "black box warnings," which are used for drugs with potentially lethal side effects.
While the study only examined Prempro, a hormone combination sold by Wyeth Pharmaceuticals, officials with the FDA say they have "new questions" about other estrogen-progestin products, which have been used for decades to control the "sometimes-severe" symptoms of menopause. Since the study's termination, women have "inundate[d]" doctors with questions on whether they should continuing using HRT. "Somebody needed to take a leadership role, because there is chaos in the medical societies," Wulf Utian, executive director of the North American Menopause Society, said, adding, "It's time to clear the air and address the issues." The FDA has pushed to immediately change Prempro's label to reflect the findings of the Women's Health Initiative. The FDA has also directed Wyeth to remove all "hormone replacement therapy" references from the label because the agency has never endorsed the "'replacement' model." Prempro only was approved for specific symptoms of menopause and to prevent osteoporosis. Florence Houn, a director at the FDA's Center for Drug Evaluation and Research, said, "As a public health agency, we need to step to the plate and reassess the risk-benefit conditions for labeling and risk management for patients."
Officials at Wyeth said they plan to supply the FDA with new safety precaution information as early as this week that takes the Women's Health Initiative study into consideration. Since the study's termination, Wyeth had stopped its direct-to-consumer advertising of HRT. However, the drug company has increased its marketing to doctors in an effort to "explain the results" of the study. "The FDA says it is our responsibility to get new information out there, and we agree," Bruce Burlington, Wyeth's vice president for regulatory compliance, said (Washington Post, 8/14).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.