Recent Postings

In 2015, the Food and Drug Administration (FDA) first approved flibanserin (ADDYI) to treat premenopausal women with hypoactive sexual desire disorder. In December 2025, the FDA expanded the drug’s approval to include postmenopausal women age 65 years and younger. Public Citizen’s Health Research continues to classify flibanserin as a Do Not Use drug.

The “From the Editor” column discusses recent public opinion polls showing that the public (1) supports rigorous standards for the approval of new drugs, not earlier access with less complete safety testing, and (2) are more confident in career scientists at U.S. agencies than in those agencies’ political leaders.

Learn about medications that increase the risk of falls, such as certain antidepressants, benzodiazepines and Z-drugs, antipsychotics, antihistamines, anti-seizure drugs, cardiovascular drugs, muscle relaxants and opioids.

In December 2025, the manufacturer of andexanet (ANDEXXA) voluntarily removed the drug from the U.S. market. The withdrawal of andexanet was long overdue. Since 2021, we have designated the drug as Do Not Use.

Guselkumab (TREMFYA) is an expensive injectable biologic drug that is widely promoted in direct-to-consumer television advertisements. Learn about the drug’s indications and safety issues, including an increased risk of infections.

In October 2025, the Food and Drug Administration (FDA) approved elinzanetant (Lynkuet), an oral medication, for the treatment of mild to severe hot flashes due to menopause. Public Citizen’s Health Research Group has classified elinzanetant as a “Do Not Use” drug based on its marginal benefits and concerns about its long-term safety.

The “From the Editor” column discusses recent developments at the FDA. The developments raise questions about the agency’s ability to make decisions based on scientific data about the safety and effectiveness of medical products, and to do so without political interference.

The recent rise of the anti-vaccine movement and vaccine hesitancy are threatening protection against measles in the United States and leading to outbreaks of measles in many areas of the country. Learn about the effectiveness and safety of the measles vaccines and the continued importance of vaccination. Importantly, well-designed studies have repeatedly found no association between measles vaccines and autism.

The rapid uptake of newer nicotine products, such as e-cigarettes and oral pouches, particularly among young people, threatens the slow progress over many years in tobacco control and poses substantial risks to cardiovascular health throughout the world. A December 2025 report in the European Heart Journal offers a policy blueprint to respond to the addictive and harmful effects of nicotine and “prevent the rise of a new generation of nicotine-addicted youth.”

Blood glucose monitors can be used in the home or health care settings. They are frequently used by patients with diabetes to guide treatment, such as to determine the best insulin dose. Recent FDA warnings about glucose monitors have highlighted the dangerous risks that may occur when these devices malfunction.

The glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide is widely used for type 2 diabetes or for chronic weight management. Learn about the Food and Drug Administration (FDA)-approved formulations of semaglutide, their indications, safety concerns, and the need for continued long-term treatment to maintain the benefits. Public Citizen’s Health Research Group recommends that these drugs only be used for an FDA-approved indication and in conjunction with a reduced-calorie diet and increased physical activity.

The “From the Editor” column discusses the four articles about semaglutide and tirzepatide in this issue, and why we are removing the Do Not Use designation for semaglutide, tirzepatide, and the GLP-1 drug class. We continue to recommend that you Do Not Use compounded semaglutide, tirzepatide or other GLP-1 products.

In 2022 the FDA approved tirzepatide, marketed as MOUNJARO and administered as a subcutaneous injection, for type 2 diabetes. In 2023 the FDA approved the same drug, marketed as ZEPBOUND, for chronic weight management. In 2025 tirzepatide overtook semaglutide as the most prescribed GLP-1 drug. Learn about the effectiveness of tirzepatide, its safety and adverse events. As is the case with semaglutide, we recommend that tirzepatide only be used for an FDA-approved indication and in conjunction with a reduced-calorie diet and increased physical activity.

GLP-1 drugs are associated with an increased risk of gastrointestinal adverse events, including serious conditions such as pancreatitis and biliary disease. A November 2025 study in the Annals of Internal Medicine compared the gastrointestinal safety of dulaglutide (TRULICITY), subcutaneous semaglutide (OZEMPIC, WEGOVY) and tirzepatide (MOUNJARO, ZEPBOUND) in adults with type 2 diabetes. The study found that the drugs have similar gastrointestinal safety profiles.

In August 2025 the FDA granted accelerated approval to injectable semaglutide (WEGOVY) to treat metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced fibrosis (excessive scar tissue in the liver). Learn about the evidence supporting this approval and why Public Citizen’s Health Research Group has designated semaglutide for MASH as Do Not Use for Seven Years.