FDA Approves New HRT Warning Label

January 08, 2003

Jeanie Davis

Jan. 8, 2003 - The U.S. Food and Drug Administration (FDA) has asked that all labels on estrogen and estrogen-progestin replacement therapy be revised to carry a boxed warning, stating the increased risks for heart disease, heart attacks, strokes, and breast cancer. The warning also emphasizes that these products are not approved for heart disease prevention.

"We have approved all new labeling for Wyeth Pharmaceuticals for Prempro, Premarin, and Premphase," said FDA spokesperson Pam Winbourne, in a teleconference with reporters. "All other manufacturers are being faxed letters asking them to revise their labels in a similar fashion.

"We believe that different estrogens and progestins act similarly, and in absence of data otherwise, women need to assume the risk with other estrogens and progestins are similar," said Ms. Winbourne. "Other studies do show that estrogens and progestins are associated with these same side effects."

The label also urges that physicians prescribe the lowest doses of estrogens and estrogen-progestin products and for the shortest duration to achieve treatment goals.

The label changes reflect findings from the Women's Health Initiative (WHI), "a landmark study that found overall health risks for estrogen with progestin - particularly for invasive breast cancer, heart attacks, blood clots - and that these risks exceeded benefits of fracture and colon cancer risk reduction," said Ms. Winbourne.

The FDA also conducted its own review of data from the WHI, and confirmed the study's findings. "We are assuring that labels...have accurate information as uncovered by the WHI," she said.

The black-box warning asks that decisions about using hormone replacement therapy balance the benefits and potential risks.

"Our actions also include new guidance for conduct of clinical trials developing products for vasomotor symptoms and vulvar and vaginal atrophy," Ms. Winbourne added, including treatment of the following specific conditions:

  • Moderate to severe vasomotor symptoms (hot flashes and night sweats). "The FDA still believes that these products are highly effective and very valuable in treating moderate to severe symptoms of hot flashes and night sweats," said Ms. Winbourne. "These symptoms can be very disruptive and often can only be controlled by estrogen products. That will not change."

  • Vaginal and vulvar atrophy. The new label states that when estrogen products are being considered only for this condition, topical vaginal products should be considered.

  • Prevention of osteoporosis. The new label states that when prescribing solely for prevention of osteoporosis, estrogen should only be considered for women at significant risk of osteoporosis — and that nonestrogen treatments such as bisphosphonates should be carefully considered.


Some 6.5 million women in the U.S. now take some form of hormone replacement therapy, Winbourne said.

Reviewed by Gary D. Vogin, MD

Jeanie Davis is a staff correspondent for WebMD.

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