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July 2024
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.
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July 2024
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.
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July 2024
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.
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July 2024
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.
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July 2024
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.
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June 2024
In January 2024, the FDA added a boxed warning — the agency’s most prominent warning — to the prescribing information for the osteoporosis drug denosumab (PROLIA) because of an increased risk of severe hypocalcemia in patients with advanced chronic kidney disease. The FDA approved denosumab in 2010. This article updates information on denosumab, which Public Citizen’s Health Research Group has designated as a Do Not Use drug.
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June 2024
The “From the Editor” column discusses the withdrawal in March 2024 of the amyotrophic lateral sclerosis (ALS) drug AMX0035 (sodium phenylbutyrate and taurursodiol), sold under the brand name RELYVRIO. In a recently completed clinical trial, the drug did not provide any clinical benefit to ALS patients. The FDA needs to take steps to ensure that it never again approves a drug without clear evidence of efficacy.
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June 2024
In October 2023, the FDA convened a workshop to discuss the use of solid, oral candy-like nonprescription drugs and supplements. These formulations have become a common delivery system for multivitamins and other dietary supplements as well as over-the-counter drugs. Learn about the pros and cons of drug formulations that look or taste like candy.
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June 2024
This article discusses recent FDA warnings about eye drops and recalls of various eye-drop products. Most of the actions were triggered by concerns about faulty production processes that may have resulted in bacterial contamination of certain brands or manufacturing lots.
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June 2024
The human papillomavirus (HPV) vaccine protects individuals from developing cervical cancer and other cancers caused by the virus, including vulvar, vaginal, anal, oropharyngeal (throat) and other head and neck cancers. Learn about a recent large, long-term observational study conducted in Scotland that adds to the evidence that HPV vaccination prevents the development of invasive cervical cancer and that even one or two doses of a bivalent (two-strain) vaccine administered one month apart are beneficial if given at 12 or 13 years of age.
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June 2024
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May 2024
In May 2023, the FDA approved fezolinetant (VEOZAH) for the treatment of moderate-to-severe hot flashes (vasomotor symptoms) due to menopause. Unlike hormone therapy, the drug was approved only for the treatment of hot flashes, not for any of the other symptoms of menopause. Learn why Public Citizen’s Health Research Group has designated fezolinetant as a Do Not Use drug.
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May 2024
The “From the Editor” column discusses the withdrawal of the controversial Alzheimer’s disease drug aducanumab (ADUHELM) from the U.S. market and recent developments with the related drug lecanemab (LEQMBI), which the FDA approved in 2023. Public Citizen’s Health Research Group has designated lecanemab as a Do Not Use drug. Lecanemab has brain-swelling and bleeding risks and neither cures nor reverses Alzheimer’s disease.
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May 2024
Learn about nirmatrelvir and ritonavir (PAXLOVID), an FDA-approved treatment for acute COVID-19 infection. The drug has potential benefits in preventing serious COVID-19 infections in patients with heightened risk, particularly if they are treated early in the course of their infection and if the risk of potentially dangerous drug interactions can be appropriately managed. When the potential benefits are small, such as for people at low risk of disease progression, nirmatrelvir and ritonavir should not be used.
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May 2024
This article discusses ways to save money on prescription drugs without compromising on quality. The approaches discussed include using generic drugs, choosing an affordable formulation, comparing prices and reaching out to discount programs and drug assistance programs.
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May 2024
Learn about a recent study that found that major drug interactions are common among outpatient children with Medicaid insurance and that these interactions often involve drugs that are routinely prescribed for children with common chronic health conditions.