Recent Postings

In November 2025 the Food and Drug Administration initiated the removal of most of the boxed warning from the prescribing information of all menopausal hormone treatments containing estrogen. The boxed warning about endometrial cancer for systemic estrogen-alone products will be maintained. Although Public Citizen’s Health Research Group is open to targeted updates to the safety warnings that incorporate recent medical evidence, we consider many of the proposed labeling changes to be unsupported.

The editor’s column discusses the public health consequences of the Centers for Disease Control and Prevention’s recent decision to replace the universal practice of administering the first dose of the hepatitis B vaccine to all newborns with “individual-based decision-making in consultation with a health care provider” for parents deciding whether to give the birth dose to infants who are born to hepatitis B surface antigen-negative women.

Learn about two new studies that found no additional benefit for bedtime dosing of once-daily antihypertensive medications in terms of reducing the risk of major cardiovascular events or decreasing safety outcomes.

In July 2025 the Food and Drug Administration required safety labeling changes to all opioid pain medications to better explain the risks of overdose and addiction. Although the labeling changes improve upon the previous labeling, learn why they fall short of the changes the agency should have required.

A recent clinical trial found that cannabidiol (CBD) doses like those used in unregulated CBD consumer products were associated with increased liver enzyme levels and, in several cases, potential drug-induced liver injury. The study findings highlight concerns about the long-term liver safety of widely used CBD products and the need for clinicians to ask patients with elevated liver enzyme levels about CBD use.

Alcohol can have clinically important and potentially dangerous interactions with many prescription and over-the-counter medications. These drug interactions are important to keep in mind during the holiday season when even people who rarely drink beer, wine or liquor may drink more alcohol than usual.

Through November 2025 the FDA has convened about a third of the number of advisory committee meetings that it convened in 2024. The “From the Editor Column” discusses the essential roles of public FDA advisory committee meetings and why the deemphasis of the meetings should be reconsidered.

Learn about a recent evidence-based guideline from the United Kingdom about the diagnosis and management of vitamin B12 deficiency. Vitamin B12 is a nutrient of particular concern for some older Americans because the body’s ability to absorb it may decrease with age or due to use of certain medications.

A comprehensive study published in JAMA Psychiatry in July 2025 found that although symptoms such as dizziness and nervousness are common when antidepressant medications are discontinued, these symptoms typically are not clinically significant and do not persist. If depressive symptoms develop later, they may indicate a relapse of depression and patients should seek medical attention.

In January 2025 the Food and Drug Administration approved meloxicam and rizatriptan (SYMBRAVO), a fixed oral combination drug for adults with acute migraine headache with or without aura. Public Citizen’s Health Research Group has designated the combination drug as Do Not Use because of the lack of adequate data about its efficacy and safety.

The From the Editor column discusses the improved public information that is now available about FDA rejection letters. Known as “complete response letters,” the rejection letters provide important information about the agency’s reasons for denying marketing applications, thus informing the public and allowing drug developers and other companies to avoid making similar mistakes.

Except for one drug for panic disorder, Public Citizen’s Health Research Group has long designated all benzodiazepines as Do Not Use for insomnia, anxiety or any other uses. Unfortunately, many patients take benzodiazepines for extended periods of time to treat conditions that can be managed with lower-risk therapies. A recent FDA-funded clinical practice guideline offers helpful evidence- and consensus-based strategies for clinicians to determine whether tapering benzodiazepines may be appropriate for patients and, if so, how to taper them.

In May 2025 the FDA approved a third COVID-19 vaccine (NUVAXOVID). Unlike the previously approved messenger ribonucleic acid (mRNA) vaccines, the main active ingredient of Nuvaxovid is the viral-surface spike protein of the SARS-CoV-2 virus that causes COVID-19. To prevent death or serious complications from COVID-19, Nuvaxovid is a good vaccine option, either as an initial two-dose series or as a booster immunization.

The FDA recently authorized the marketing of a medical device that analyzes a blood sample and concludes from the analysis whether amyloid plaques are present in the brain. Learn why the medical device has limited clinical uses and should not be used as a standalone diagnostic or screening tool for Alzheimer’s disease in asymptomatic older patients.