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October 2024
In 2023 the Food and Drug Administration (FDA) approved daprodustat (JESDUVROQ), an oral drug for anemia due to chronic kidney disease. Daprodustat is only approved for chronic kidney disease patients who have been receiving dialysis for at least four months. Public Citizen’s Health Research Group has designated daprodustat as Do Not Use for seven years because the drug has no truly unique benefits over erythropoiesis-stimulating agents and not enough is known about its potential long-term risks.
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October 2024
In June 2024 the FDA expanded its earlier approval of delandistrogene moxeparvovec-rokl (ELEVIDYS), a gene therapy for patients with Duchenne muscular dystrophy. The editor’s column discusses the problems with the decision and why the FDA should not have granted the gene therapy accelerated approval in 2023, nor full approval in 2024.
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October 2024
Learn about sexual problems (dysfunction) that can occur during treatment with drugs in two commonly used antidepressant drug classes — selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors — and why Public Citizen has sued the FDA to compel a decision on a 2018 petition requesting the addition of boxed warnings, the most prominent warnings that the FDA can require.
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October 2024
Two recent observational studies add to the evidence that the use of stimulant medications to treat attention deficit hyperactivity disorder (ADHD) increases the risk of cardiovascular disease, a risk that may persist even after patients discontinue the drug.
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October 2024
Biologic drugs, which include certain vaccines, insulin and monoclonal antibodies, are made from living cells or microorganisms; they are the fastest-growing medication class in the United States. Learn about biologic drugs and biosimilars, which have a shorter approval process and may be more affordable. As of August 2024 the FDA had approved 58 biosimilars for many reference biologic drugs.
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September 2024
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).
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September 2024
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.
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September 2024
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.
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September 2024
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.
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September 2024
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.
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August 2024
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.
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August 2024
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.”
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August 2024
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.
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August 2024
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.
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August 2024
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.