FDA removes warning label from menopause drugs

The FDA will remove the menopause drug warning from hormone therapies, citing updated evidence on stroke and heart risks.

US health officials said Monday they will drop the boxed warning — the strongest safety alert on a drug label — from more than 20 pills, patches and creams with hormones such as oestrogen and progestin, used to ease hot flushes and night sweats.

The 22-year-old warning told doctors that hormone therapy raises the risk of blood clots, heart problems and other issues, based on an influential study published more than 20 years ago.

FDA commissioner Marty Makary called the current label outdated and unnecessary. Officials pointed to studies suggesting hormone therapy carries few risks when started before age 60 and within 10 years of symptoms beginning.

Health secretary Robert F. Kennedy Jr. said: “We’re challenging outdated thinking and recommitting to evidence-based medicine that empowers rather than restricts.”

Medical guidelines generally advise limited-duration use in younger women going through the menopause who do not have complicating risks, such as breast cancer.

The FDA’s updated prescribing information largely aligns with that approach.

Makary and some other doctors have argued that benefits may extend beyond symptom relief.

Before becoming FDA commissioner, Makary devoted a chapter of his latest book to what he described as the overall benefits of hormone therapy and criticised doctors unwilling to prescribe it.

On Monday he repeated that view, citing figures suggesting hormone therapy reduces heart disease, Alzheimer’s and other age-related conditions.

Makary told reporters: “With few exceptions, there may be no other medication in the modern era that can improve the health outcomes of women at a population level more than hormone replacement therapy.”

The scale of those benefits remains under study. Dr JoAnn Manson of Harvard Medical School said the evidence for overall health benefits is not “as conclusive or definitive” as Makary suggested.

Still, she said removing the warning could help doctors and patients make more personalised decisions.

Manson said: “The black box is really one size fits all. It scares everyone away. Without the black box warning there may be more focus on the actual findings, how they differ by age and underlying health factors.”

In the 1990s, more than one in four US women took oestrogen alone or with progestin, amid assumptions it would cut rates of heart disease, dementia and other problems, as well as treat symptoms.

But a landmark study of more than 26,000 women challenged that, linking two hormone pill types to higher rates of stroke, blood clots, breast cancer and other serious risks.

After the 2002 findings were published, prescriptions fell across age groups.

Makary said: “That study was misrepresented and created a fear machine that lingers to this day.”

A new analysis of the 2002 data, published in September, found women in their 50s on oestrogen-based drugs had no increased risk of heart problems, while women in their 70s did; the data for women in their 60s was unclear.

Since the early 2000s, newer forms have arrived, including vaginal creams and tablets that deliver lower doses than pills and patches.

The original warning language will still be available to prescribers but placed lower on the label.

he drugs will keep a boxed warning that women who have not had a hysterectomy (surgical removal of the uterus) should take a combination of oestrogen-progestin due to the risk of cancer in the uterine lining.

Rather than convening one of the FDA’s standing advisory committees on women’s health or drug safety, Makary earlier this year invited a dozen doctors and researchers who overwhelmingly supported the health benefits of hormone-replacement drugs.

Many of the panellists at the July meeting consult for drugmakers or prescribe the medicines in private practice. Two of the experts also spoke at Monday’s FDA news conference.

Asked on Monday why the FDA did not convene a formal advisory panel, Makary said such meetings are “bureaucratic, long, often conflicted and very expensive.”

Diana Zuckerman of the non-profit National Centre for Health Research accused Makary of undermining the FDA’s credibility by announcing the change “rather than having scientists scrutinise the research at an FDA scientific meeting.”