Recent Postings

Learn about the clinically important and potentially dangerous drug interactions for the widely used anticoagulant apixaban (ELIQUIS). The most concerning interactions are with drugs that enhance the action of apixaban (causing bleeding) or diminish its effects (causing thrombotic events).

The editor’s column discusses a recent example of tobacco industry funding of continuing medical education and calls on the Accreditation Council for Continuing Medical Education to revise its standards and ban such funding.

The FDA recently approved two additional drugs for opioid use disorder, both of which are nasal spray formulations. One drug is high-dose naloxone and the other is a derivative of naloxone known as nalmefene (OPVEE). Naloxone nasal spray, which is sold over the counter, is a safer choice. The newer formulations are more expensive, usually no more effective and may trigger longer and more intense withdrawal.

In 2023 the FDA approved ritlecitinib (LITFULO), an oral drug that suppresses the immune system, for the treatment of severe alopecia areata in adults and adolescents age 12 years and older. Public Citizen’s Health Research Group has designated this drug as Do Not Use because the possible limited benefits do not outweigh the serious harms.

Learn about resmetirom (REZDIFFRA), the first drug that the FDA has approved for a severe form of nonalcoholic fatty liver disease known as nonalcoholic steatohepatitis (NASH). Because the clinical benefits of resmetirom have not been directly established and its long-term safety and effectiveness are unknown, Public Citizen’s Health Research Group has designated resmetirom as a Do Not Use drug.

The tumor necrosis factor blocker adalimumab (HUMIRA and biosimilars) is used to treat rheumatoid arthritis and various autoimmune diseases. It is one of the best-selling drugs in the United States. Learn about the efficacy of adalimumab, its serious adverse effects and why Public Citizen’s Health Research Group has classified this biologic drug as Limited Use.

The Food and Drug Administration is considering how to improve the agency’s “use of and processes for advisory committees.” The editor’s column discusses the importance of voting at advisory committee meetings and argues that de-emphasizing votes is a “bad idea.”

First approved by the Food and Drug Administration in 1952, repository corticotropin injection (ACTHAR GEL) is a long-acting and expensive medication for the treatment of more than a dozen autoimmune and inflammatory diseases, such as exacerbations of multiple sclerosis in adults. Corticotropin usually performs no better than glucocorticoids, such as prednisone and prednisolone, for most of the same indications and should rarely be prescribed.

Tianeptine is an addictive synthetic chemical substance with opioid-like effects that is associated with serious health risks and even death. The Food and Drug Administration (FDA) classifies tianeptine as an unsafe food additive and has not approved it for any medical use. Stronger FDA actions are needed to remove tianeptine from the U.S. market.

People with subclinical hypothyroidism have normal levels of a form of thyroid hormone used by the body and usually have no symptoms. The diagnosis is based on laboratory test results. Learn about a large multicenter European study, published in 2024, that found that subclinical hypothyroidism often resolves without drugs in older adults.

Adults aged 65 or older are at high risk of experiencing drug interactions and adverse events. This article highlights five drug classes that are associated with increased risks for older adults: benzodiazepines and Z drugs; anticholinergic medications; sulfonylureas, drugs for type 2 diabetes; cardiovascular and anti-thrombotic medications; and antipsychotics in older adults with dementia.

In 2023, the Universities Allied for Essential Medicines North America filed a citizen petition with the FDA to increase enforcement of the ClinicalTrials.gov reporting requirements and impose fines when appropriate. Learn about the FDA’s response to the petition, which granted some of the requests and denied others.

In December 2023, the FDA approved a DNA (genotyping) test for the risk of developing opioid use disorder (AvertD). Public Citizen’s Health Research Group opposed approval of the test because the pivotal clinical trial was flawed and because had high rates of both false negative and false positive results. Although the test is not yet widely available, we have classified it as Do Not Use.

Almost one-third of older men experience lower urinary tract symptoms, such as hesitancy or slow urinary stream, dribbling or incomplete emptying of the bladder, urinary urgency or need to urinate many times during the day or at night. Learn about a recent clinical trial, published in the BMJ, that found that use of standardized assessments and lifestyle advice for men in the primary-care setting led to sustained reductions in urinary symptoms compared to usual care.

Because many drug reactions are not reported to the FDA, drug safety information may not adequately represent the adverse events that patients experience. A study published in Drug Safety found that sociodemographic factors, such as living in a county with higher percentages of African American, American Indian or Alaska Native residents; higher rates of lack of access to health care; low English proficiency; and lower household income, contribute to lower rates of adverse event reporting.