Recent Postings

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.

Learn about zoledronic acid (RECLAST and generics), a drug approved for the treatment and prevention of osteoporosis in postmenopausal women and for other uses. Based on a review of new evidence, Public Citizen’s Health Research Group has designated zoledronic acid as a Limited Use drug for osteoporosis in postmenopausal women.

The “From the Editor” column discusses the recent recommendation from the Advisory Committee on Immunization Practices that children, pregnant women, and adults receive only single-dose formulations of the annual influenza (flu) vaccine that are free of thimerosal, a mercury-based preservative, and the reasons why the recommendation was misguided.

Approved by the Food and Drug Administration in 2012, linaclotide (LINZESS) is an expensive drug for constipation and for symptoms of irritable bowel syndrome with constipation. Based on our review, we have designated linaclotide as a Do Not Use drug because the randomized placebo-controlled trials supporting its approval demonstrated that its limited benefit (symptomatic relief of constipation in about one of five users) is offset by its diarrhea adverse effects (also reported by about one of five users).

A large observational study using data from Ontario, Canada, focuses attention on an increased risk of dementia in people with marijuana (cannabis) use that is intensive enough to require hospital-based care.

Benzoyl peroxide products, available in over-the-counter and prescription topical formulations such as creams, gels, lotions and washes, are used to treat acne due to their bactericidal activity. However, many of these products contain high levels of benzene, a chemical known to cause cancer and other blood cell cancers. Learn about additional evidence that supports a petition to the Food and Drug Administration to request a recall and suspension of. products containing benzoyl peroxide.

In 2024 the Food and Drug Administration approved the oral drug benzgalantamine (ZUNVEYL) for the treatment of mild or moderate dementia in adults with Alzheimer’s disease. Both benzgalantamine and the related drug galantamine (approved in 2001) have serious safety concerns and minimal benefit. Moreover, there is no convincing evidence that the new drug is easier for patients to take than the old drug. Public Citizen’s Health Research Group has classified benzgalantamine as a Do Not Use drug.

The “From the Editor” column discusses a ProPublica investigation of the FDA’s oversight of foreign factories, where many generic drugs sold in the United States are manufactured. ProPublica’s central finding is particularly disturbing. The FDA, without any public warning, permitted more than 150 drugs or their ingredients into the country over the past 12 years even though they were manufactured at factories banned from shipping products to the United States.

In June 2025 the Food and Drug Administration approved lenacapavir (YEZTUGO), a twice-yearly injectable HIV drug to prevent sexually acquired HIV infection in adults and adolescents weighing at least 35 kilograms (77 pounds). At present, lenacapavir is highly effective and has not raised safety concerns. An alternative to daily oral preexposure prophylaxis (PrEP) drugs, lenacapavir offers long-lasting protection against HIV, although the drug is not a vaccine in the traditional sense.

Learn about Public Citizen’s May 2025 petition to the Food and Drug Administration to request contraindicating the use of the widely used oral wakefulness-promoting drugs modafinil (PROVIGIL and generics) and armodafinil (NUVIGIL and generics) during pregnancy due to their potential to cause major congenital malformations in exposed babies.