FDA Approves New HRT Warning Labels

Warnings Cite Health Risks of Estrogen Products

From the WebMD Archives

Jan. 8, 2003 -- For women, it's the closest thing to the final word on hormone replacement therapy (HRT). The FDA has asked that all labels on estrogen and estrogen-progestin HRT products be revised to carry a "high-level warning."

The new box warning, the highest level of warning information in labeling, will state 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 spokeswoman 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 Winbourne. "Other studies do show that estrogens and progestins are associated with these same side effects."

The FDA also urges that women take only the lowest doses of estrogens and estrogen-progestin products -- and for the shortest duration to achieve treatment goals, says Winbourne. "Women should regularly discuss with their healthcare providers if they need to continue treatment," she said.

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 Winbourne.

Also, the FDA conducted its own review of data from the WHI study and has worked with Wyeth to approve the new labeling approved today for these products. "We are assuring that labels ... have accurate information as uncovered by the WHI," she said.

The box warning asks that each woman make her own decision on using the product, balancing the benefits and potential risks.

"Women need to talk with their healthcare providers about estrogen and estrogen- progestin products and whether they are still needed periodically," she said.

The FDA has also modified two of the approved uses for the products:

  • Vaginal and vulvar atrophy (dryness and irritation) associated with menopause. The new label states that when estrogen products are being considered only for this condition, topical vaginal products should be considered.
  • Prevention of postmenopausal osteoporosis. The new label states that when prescribing solely for prevention of osteoporosis, estrogen and estrogen-progestin combinations should be considered only when the benefits outweigh the risks of such treatment and that non-estrogen treatments (such as bisphosphonates) should be carefully considered.
  • For moderate to severe vasomotor symptoms (hot flashes and night sweats) associated with menopause, "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 Winbourne. "These symptoms can be very disruptive and often can only be controlled by estrogen products. That will not change."

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