In brief

• The FDA has removed black box warnings about cardiovascular risk, breast cancer and dementia from the packaging of three estrogen patch products.
• The agency did not convene an advisory committee and said it would make the scientific documentation available later.
• In February, the FDA removed similar warnings from six hormonal products, also without an opinion from a committee.
• The change applies to labels in the USA and does not modify medical recommendations in force in Poland.

Another change without an advisory committee

The U.S. Food and Drug Administration (FDA) announced on Friday that the packaging of three estrogen patches will no longer carry black box warnings concerning cardiovascular disease, breast cancer and dementia (FDA again bypasses advisers to remove black-box warnings from menopause treatments – The Guardian) (US health department to remove broad black box warning from three estrogen patch products - SRN News – srnnews.com). This is the most severe category of warnings on drug labels in the USA. The agency did not convene an advisory committee, and during the press briefing it presented little data on which the decision was based.

No evidence on the spot

When journalists asked about the scientific basis, officials replied that the documentation would be provided later. Reshma Ramachandran, a researcher at the Yale School of Medicine, expressed concern about the lack of transparency in decisions of this kind.

Background: patch shortages

The decision comes at a time when patients in the USA have difficulty accessing estradiol patches, used for hot flashes, mood swings and sleep disturbances, and demand has risen sharply (Menopause patch black box warnings removed as American women face treatment shortages | The Independent – the-independent.com). The Department of Health and Human Services did not immediately respond to questions about the brand names of the modified products.

Since September the FDA has been talking with manufacturers about increasing supply, but it has not formally recognized these patches as products in shortage. Dorothy Fink, deputy director of the National Institute of Child Health and Human Development, said during the briefing that patch production had doubled over the past year.

Earlier changes

This is not the first change to menopause therapy labels. In February the FDA allowed the removal of warnings concerning breast cancer, heart disease and probable dementia from six hormonal products. The agency also did not seek an advisory committee opinion at that time (FDA removes warnings from three estrogen patches — The Guardian | UA.NEWS – ua.news).

What it means for patients in Poland

The decision concerns only the packaging of drugs authorized for marketing in the United States. It does not change the summary of product characteristics of medicines used in Poland, nor is it a basis for independently modifying hormone therapy. Any changes to the dose, preparation or discontinuation of treatment are decided by the attending physician, who assesses individual risk, including the patient's age and duration of hormone use.