The U.S. Food and Drug Administration will no longer require warnings about hormone replacement therapies that some doctors say have long kept women from taking medications designed to treat menopausal symptoms.
Since 2003, medications for menopausal women have included a black box warning (a safety warning issued by the Food and Drug Administration indicating serious or potentially fatal risks associated with a drug in the United States; the warning appears in a black box at the top of the label and on the package) indicating that they may increase the risk of heart attacks, strokes, blood clots, and certain types of cancer.
The push for black box warnings, the strongest safety warning the agency can give for a drug, came after early results of a national health study known as the Women’s Health Initiative, funded by the National Institutes of Health. But the scientific evidence behind this warning has changed over the past two decades.
The FDA is asking drug manufacturers to remove black box warnings, a change that has been a top priority for FDA Commissioner Marty McCurry.
“Hormone replacement therapy may improve health outcomes for women at a population level more than any other intervention, perhaps with the exception of antibiotics or vaccines, for example,” McCary told reporters on Monday.
Leading medical societies — such as the Menopause Society and the American College of Obstetricians and Gynecologists — have long advocated reevaluating the warning label for low-dose vaginal estrogen products.
Recent research shows that for healthy women who have recently stopped menstruating, estrogen therapy is generally safe and effective with individual patient counseling, but the potential risks vary depending on whether the treatment is administered vaginally or in the form of tablets, patches, gels or sprays. Some doctors say that estrogen is the most effective treatment for classic symptoms like hot flashes and vaginal dryness.
McCary said he believes drug makers will welcome the change and change their labels, adding that the process will likely take several months. Potential adverse safety events will be included in the regular classification, in the interest of a “careful discussion” that includes the age of the woman seeking to use the drugs, McCary said.
The U.S. Food and Drug Administration (FDA) is working with companies to update language to remove references to cardiovascular disease risks, breast cancer and possible dementia, according to the Department of Health and Human Services. The FDA is not seeking to remove the endometrial cancer warning for systemic estrogen-only products.
The agency said decisions about hormone replacement therapies should be made between the patient and her doctor, although the recommendation on the product label is to start treatment within 10 years of the onset of menopause or before age 60 for systemic treatments such as pills, patches, gels or sprays.
“Revisions to some warning labels have been in the works for years,” ACOG President Steven J. Fleishman said in a statement. The updated labels remove “an unnecessary hurdle when it comes to treating menopausal symptoms.”
However, he and others caution that HRT is not a panacea for women’s overall health and that risks remain.
The foundation of hormone replacement therapy is estrogen and progesterone, says Sarah Shelley, a certified nurse-midwife who is also a certified practitioner with the Menopause Society.
Estrogen stimulates the growth of the uterine lining. Progesterone prevents this lining, or endometrium, from becoming too large, she said, adding that the two perform an “elegant dance.”
“For anyone who still has a uterus, we should also give progesterone,” says Shelley, who runs a private practice focusing on the postpartum period and menopausal transition.
Black box warnings about estrogen products are “a really big deterrent,” says Shelly, who attended part of a meeting called by the Food and Drug Administration in July to discuss the benefits and risks of hormone replacement therapy, sometimes referred to as HRT. She agreed with several committee members that the warnings should be removed.
The FDA’s move comes just over a week after turmoil rocked the agency. George Tidmarsh, a recently appointed senior drug regulatory official, resigned on November 2, amid scrutiny over his comments critical of a treatment made by Aurinia Pharmaceuticals, officials said.
The Canadian pharmaceutical company filed a lawsuit on the same day, accusing him of making false statements and soliciting bribes due to a “long-standing personal vendetta” against Orenia’s chairman. Tidmarsh is listed as an author on a JAMA opinion article on changing hormone therapy, which was published Monday.
Attendees at the HHS event on change included Second Lady Osha Vance and Health Secretary Robert F. Kennedy Jr.’s wife, Cheryl Hines.
Some researchers say the decision whether to use hormonal treatments should be approached in a similar way to any other medication.
However, “there is tremendous fear among women and doctors about using estrogen therapy,” Kaufman says.
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