FDA Pulls Warning Labels From Hormone Replacement Therapies

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(Bloomberg) — Hormone replacement therapies used to treat menopause symptoms no longer need to carry strict warnings about potential side effects, including cancer and heart disease, the US Food and Drug Administration announced Monday.

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Commissioner Marty Makary said the agency is asking drugmakers to remove the strict black box warnings, with the goal of encouraging more women to take them. Labels on the medicines currently list potential side effects including cardiovascular disease, blood clots, breast cancer and dementia.

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The agency also approved a generic version of Pfizer Inc.’s Premarin, once the biggest-selling drug in the US. Hormone replacement therapy eases menopause symptoms like hot flashes, night sweats and vaginal dryness, while boosting energy and strengthening bone. But some doctors and researchers have worried about the risks from years or even decades of use.

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Prior research suggesting hormone therapy increased the risk of breast cancer was based on a formulation that is no longer normally prescribed, the US Department of Health and Human Resources said in a statement. Approval of the first generic version of Premarin in more than 30 years is intended to make it more broadly available at a lower cost, while maintaining the quality, safety and effectiveness of the original.

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“Tragically, tens of millions of women have been denied the life-changing and long-term health benefits of hormone replacement therapy,” Makary said. “For too long, issues of women’s health have been underrecognized. Women and their physicians should make decisions based on data, not fear.”

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In 2002, researchers halted a study of 16,000 women after data emerged showing those given a combination of estrogen and progestin in the US government-funded trial had higher rates of breast cancer, stroke and other complications. Over the next two decades, use by women in their 50s and early 60s plummeted by 88%.

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Researchers subsequently determined that some of the findings were misinterpreted and applied too widely. Follow-up studies found the benefits of hormones outweigh the risks for many women under 60 and those who began treatment within 10 years of starting menopause, while the risks of heart attacks and strokes increased for those who start therapy in their 60s and 70s.

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While women once took a pill, which has been linked to blood clots, they can now get a different form of the hormone from a patch, gel, spray or vaginal ring, which appear to be safer. The FDA is working with companies to remove references to the risks of heart disease, breast cancer and dementia, while leaving in place a warning about endometrial cancer for women getting only estrogen.

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JoAnn Manson, a professor of medicine at Harvard Medical School and a principal investigator of the 2002 study, said the removal of the black box warning for vaginal estrogen is likely to be widely applauded, but the change may be more controversial for systemic hormone therapy.