Black Box Warning

FDA Warning on COVID Vaccines: Trust Eroded, Science Questioned

The FDA is reportedly planning to issue “black box” warnings for COVID-19 vaccines, a move that has shocked outside experts. This plan, orchestrated by Dr. Vinay Prasad, is intended to warn about potential risks. This plan has sparked controversy due to the lack of transparency and a potential undermining of the vaccines’ safety, with many public health experts demanding supporting data. Critics worry this action may erode public trust in vaccines, potentially leading to unnecessary loss of life, especially since the move does not appear to follow established scientific processes.

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FDA Hormone Therapy Warnings Lifted: Skepticism and the Road Ahead

The Food and Drug Administration (FDA) is removing black box safety warnings from hormone therapy treatments for menopause, citing a review of recent scientific evidence. The warnings, which previously highlighted risks of cancer, dementia, heart attacks, and strokes, will be removed to increase accessibility and facilitate shared decision-making between patients and clinicians. Despite this change, systemic estrogen products still carry potential risks, and the American College of Obstetrics and Gynecology (ACOG) emphasizes the importance of individual consultations. The FDA’s decision, however, has drawn some criticism, as it bypassed the usual advisory committee process.

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