Il Nuovo Postiglione - US to remove warnings from menopause hormone therapy

Hormone Replacement Therapy can be taken to replace estrogen that the body stops producing during menopause -- the natural process that ends female reproductive years -- with the aim of alleviating symptoms that can be physically and mentally debilitating including hot flashes, brain fog, insomnia, night sweats, joint pain and bone loss.

It once was used routinely, but a major 2002 study that was aimed at exploring how the therapies could prevent chronic disease pointed to risks associated with specific HRT formulations.

Since then "black box warnings" -- the strongest warning the US Food and Drug Administration can require on prescription drugs -- have sounded alarm over increased HRT risks including of certain cancers, cardiovascular conditions and probable dementia.

Prescription and use of the therapies over recent decades plummeted.

But the matter remains one of debate, and critics have pointed to flaws with the early-2000s study, whose trials were halted as risks appeared: namely it focused on women who were on average a decade-post menopause and in their 60s, when cardiovascular risks increase regardless.

Today guidance generally indicates that newly menopausal or perimenopausal women -- broadly in their late 40s or 50s -- are potential candidates for treatment.

There also are newer, more localized or lower-dose forms of the therapies available.

"We're challenging outdated thinking and recommitting to evidence-based medicine that empowers rather than restricts," US health chief Robert F. Kennedy Jr said in introducing the measure.

- More nuance -

Many members of the medical community have urged revisiting the label, which they say can scare women for whom benefits may outweigh risks.

Others have voiced concern that changes shouldn't come without a transparent review process that convenes independent experts.

FDA head Marty Makary dismissed that notion in a Monday briefing, saying such committees are "bureaucratic, long, often conflicted and very expensive.

"People have felt demoralized in this field. We've made almost no progress in assessing the evidence for years."

FDA officials have emphasized the new label will provide for more nuanced discussion between patients and doctors in evaluating whether HRT can be right for individuals.

Typically women in a low-risk category have healthy vitals including weight and blood pressure as well as normal-range cholesterol levels, with no history or a lower risk of developing breast cancer. They are also within the first 10 years of beginning menopause.

The president of the American College of Obstetricians and Gynecologists, Steven Fleischman, commended the FDA's move, saying "the updated labels will better allow patients and clinicians to engage in a shared decision-making process."

Fleischman said in a statement the change would not shift the ACOG's guidance on estrogen therapy, but noted it was important to distinguish between systemic estrogen products -- including methods taken orally or via patches -- and low-dose vaginal estrogen.

"Like all medications, systemic estrogen products are not without risk, and their use should be based on an individualized conversation between patients and their clinicians," the health association said.

The FDA said it is not seeking to remove the boxed warning for endometrial cancer for systemic estrogen-alone products.

Q.Bernardi--INP