https://www.zerohedge.com/news/2025-03-24/are-elderly-being-dosed-dangerous-antipsychotic-drugsAntipsychotic medication was the subject of a ¨black box¨ warning, issued by the FDA in 2005 and then again, in 2008. The warnings, which stated that the drugs should not be given to those over sixty years of age, was largely ignored by the elder care industry and by prescribing doctors. According to Psychiatry Online, “The prescribing labels of all antipsychotics are now required to carry a standard warning.”
“The boxed warning will say that elderly patients with dementia-related psychosis and treated with antipsychotics have an increased risk of death,” said Thomas Laughren, M.D., director of the Division of Psychiatry Products at the FDA's Center for Drug Evaluation and Research, at a June 16 press conference. The revised labels were to be finalized within 30 days of the mandate.
The first round of black box warnings, in 2005, were aimed at second generation antipsychotics, atypical antipsychotics, such as Aripiprazole (Abilify), Asenapine (Saphris), Brexpiprazole (Rexulti), Cariprazine (Vraylar), Clozapine (Clozaril), Iloperidone (Fanapt), Lurasidone (Latuda), Olanzapine (Zyprexa), Paliperidone (Invega), and Quetiapine (Seroquel). The 2008 warning was extended to all antipsychotic medication, including first generation, including Chlorpromazine (Thorazine), Fluphenazine (Prolixin), Haloperidol (Haldol), Loxapine (Loxitane), Perphenazine (Trilafon), Pimozide (Orap), Thiothixene (Navane), and Trifluoperazine (Stelazine).
These “black box warnings” were issued due to acknowledgement of increased risk of death in the elderly who took these medications. According to an article in the British Medical Journal, published in 2024
https://www.bmj.com/content/385/bmj-2023-076268 ”The main outcomes were stroke, venous thromboembolism, myocardial infarction, heart failure, ventricular arrhythmia, fracture, pneumonia, and acute kidney injury, stratified by periods of antipsychotic use, with absolute risks calculated using cumulative incidence in antipsychotic users versus matched comparators. An unrelated (negative control) outcome of appendicitis and cholecystitis combined was also investigated to detect potential unmeasured confounding.”
