Search: tag:"Boxed Warning"

12/16/2024

-1.8 years

十一月十六 National Chocolate Covered Anything Day

Health09/25/2026@HealthDesk

FDA Puts a Boxed Liver-Injury Warning on Menopause Drug Veozah

Mahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States

Astellas Pharma

FDA Puts a Boxed Liver-Injury Warning on Menopause Drug Veozah

Starts 12/16/2024CONFIRMED 87% CONFIDENCEThe FDA^[1][5] drug safety communication carries the entry "12-16-2024 Update: FDA adds a Boxed Warning, our most prominent warning, to highlight the known risk of rare but serious liver injury".

The FDA adds a boxed warning, its most prominent, to Astellas' hot-flash pill Veozah after a patient suffered serious liver injury within about 40 days of starting it, and orders monthly liver tests for the first months.

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11/10/2025

-320 days

九月廿一 National Vanilla Cupcake Day

Health09/25/2026@HealthDesk

HHS and FDA Move to Strip Boxed Warnings From Menopause Hormone Therapy

U.S. Department of Health and Human Services, 200, Independence Avenue Southwest, Ward 6, Washington, District of Columbia, 20201, United States

U.S. Food and Drug Administration

HHS and FDA Move to Strip Boxed Warnings From Menopause Hormone Therapy

Starts 11/10/2025 4:09PMCONFIRMED 86% CONFIDENCEThe FDA^[1][3] news release is headed "For Immediate Release: November 10, 2025" and says Kennedy and Makary "made the announcement at a press conference at HHS"; CBS News' livestream of it began at 16:09 UTC.

At an HHS press conference, Robert F. Kennedy Jr. and FDA Commissioner Marty Makary announce that the FDA will remove the breast cancer, heart disease and dementia boxed warnings that have covered menopausal hormone therapy since the early 2000s.

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02/12/2026

-226 days

腊月廿五 National Freedom to Marry Day

Health09/25/2026@HealthDesk

FDA Approves First HRT Labels Without the Breast Cancer Boxed Warning

Mahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States

U.S. Food and Drug Administration

FDA Approves First HRT Labels Without the Breast Cancer Boxed Warning

Starts 02/12/2026CONFIRMED 84% CONFIDENCEThe FDA^[1][4] news release is headed "For Immediate Release: February 12, 2026" and says the FDA "has approved drug labeling changes to six menopausal hormone therapy products".

The FDA approves new labels for six menopausal hormone therapy products, one from each class, that drop the cardiovascular, breast cancer and dementia statements from the boxed warning; 29 companies have filed changes.

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Pins matching tag:"Boxed Warning"

FDA Puts a Boxed Liver-Injury Warning on Menopause Drug Veozah

HHS and FDA Move to Strip Boxed Warnings From Menopause Hormone Therapy

FDA Approves First HRT Labels Without the Breast Cancer Boxed Warning