Doctors Urge FDA to Remove Black Box Warning from Estrogen for Menopausal Women

For over two decades, a black box warning has accompanied all estrogen-containing products prescribed for menopausal women, cautioning about potential risks like heart attacks, strokes, blood clots, and breast cancer. However, recent findings have called these warnings into question, prompting a group of renowned doctors to request that the FDA reconsider and remove this warning.

The initial warning: A historical context

In 2002, the Women’s Health Initiative (WHI) issued alarming findings suggesting that combined estrogen and progestin (E+P) therapy might pose significant health risks. This led the FDA to mandate black box warnings for these products. At the time, the WHI’s conclusions were based on an early termination of their study due to perceived risks.

A reversal of findings

Fast forward to today, and the landscape of understanding has dramatically shifted. The very researchers behind the WHI study, along with other scientists, have debunked the original claims:

Effectiveness of Hormone Therapy (HT): Hormone therapy remains the most effective treatment for menopausal vasomotor symptoms, significantly enhancing quality of life for many women. However, a 2023 FDA report indicates that only 10.5% of symptomatic women have used any form of HT.

Cardiovasular Benefits: Initiating estrogen therapy within ten years of menopause onset can reduce the risk of heart disease by 40 to 50%.

Bone Health: Hormone therapy has been linked to a 33% reduction in hip fractures

Stroke and Blood Clots: Over 13 years of follow-up, no increased risk of stroke, venous thromboses, or pulmonary emboli was observed.

Breast Cancer: Long-term follow-up of the WHI study revealed that women on estrogen alone had a 23% reduced risk of breast cancer, a 40% reduced risk of breast cancer death, and lower overall mortality rates following a breast cancer diagnosis compared to those on a placebo.

The call to action

Given these findings, a group of prominent doctors—including Dr. Avrum Z. Bluming, Dr. Carol Tavris, Dr. Philip Sarrel, Dr. David L. Katz, and Dr. Andrew M. Kaunitz—have penned a letter to Dr. Robert M. Califf, the Commissioner of Food and Drugs, urging the FDA to remove the outdated black box warning. They argue that this move is necessary to correct the widespread misinformation that has led many physicians to avoid prescribing hormone therapy out of unfounded fear.

How you can help

Dr. Avrum Z. Bluming is calling on others to join this effort. If you believe in the importance of accurate information and want to support this cause, you can help by emailing the FDA to advocate for the removal of the black box warning. We’ve already written the email for you.

All you have to do is click here, add your name, and press send.

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