Lesson 4 FDA’s Perspective on HRT: Balancing Risks and Benefits

FDA’s Perspective on HRT

The US Food and Drug Administration (FDA) has taken a firm stance on hormone replacement therapy (HRT). According to a report from WebMD on January 8, 2003, the FDA has requested revisions to the labels of estrogen and estrogen progestin replacement therapy products. These labels will now carry a boxed warning, highlighting the increased risks associated with heart disease, heart attack, stroke, and breast cancer. It is important to note that these products are not approved for preventing heart disease.

The FDA spokesperson, Pam Winbourne, stated that the agency has approved new labeling for specific products from WYETH Pharmaceuticals, such as Prempro, Premarin, and Premphase. Other manufacturers have also been asked to revise their labels accordingly. The FDA believes that different estrogen and progesterone products act similarly unless data suggests otherwise. This means that women need to be aware of the risks associated with other estrogens and progestins.

The label changes are based on findings from the Women’s Health Initiative (WHI), a significant study that revealed health risks associated with estrogen and progesterone use, including an increased risk of invasive breast cancer, heart attacks, and strokes. The risks were found to outweigh the benefits of fracture and colon cancer risk reduction. The FDA conducted its own review of the WHI data and confirmed these findings.

The new labels emphasize the importance of prescribing the lowest effective dose of estrogen and estrogen progestin products for the shortest duration necessary to achieve treatment goals. The FDA encourages physicians to carefully balance the benefits and potential risks when making decisions about hormone replacement therapy. Additionally, the agency has provided new guidance for conducting clinical trials related to menopausal symptoms and conditions such as vaginal atrophy.

It is important to note that the FDA still recognizes the effectiveness and value of these products in treating moderate to severe symptoms of hot flashes and night sweats, which can significantly disrupt a woman’s life. However, for specific conditions like vaginal and vulvar atrophy, the new label suggests considering topical vaginal products. Similarly, for the prevention of osteoporosis, estrogen should be considered for women at significant risk, while non-estrogen treatments like bisphosphonates should be carefully evaluated.

Currently, around 6.5 million women in the US are using some form of hormone replacement therapy. The FDA’s actions aim to provide accurate information, raise awareness about potential risks, and guide physicians in making informed decisions when prescribing HRT.