Accelerated approval drug labels often lack information for clinical decision-making.

Study Objective: We evaluated US Food and Drug Administration labels for drugs approved under the accelerated approval pathway and whether these labels contained in sufficient information regarding their accelerated approval.

Design: Retrospective, observational, cohort study.

Data Source: Label information for drugs with an accelerated approved indication were ascertained from two online platforms: Drugs@FDA and FDA Drug Label Repository.

Medicare Expenditures of Atezolizumab for a Withdrawn Accelerated Approved Indication.

This cross-sectional study examines atezolizumab as a second-line treatment for malignant urothelial carcinoma, which received accelerated US Food and Drug Administration approval, although the manufacturer’s confirmatory trial did not identify benefits.

End of an era for erythropoiesis-stimulating agents in oncology.

Erythropoiesis-stimulating agents (ESAs) are available to treat chemotherapy-induced anemia (CIA). In 2007-2008, regulatory notifications advised of venous thromboembolism and mortality risks while the Center for Medicare and Medicaid Services' restricted ESA initiation to patients with hemoglobin <10 g/dl. In 2010, a Risk Evaluation and Mitigation Strategies required consent prior to administration.

An evaluation of reports of ciprofloxacin, levofloxacin, and moxifloxacin-association neuropsychiatric toxicities, long-term disability, and aortic aneurysms/dissections disseminated by the Food and Drug Administration and the European Medicines Agency.

: Ciprofloxacin, levofloxacin, and moxifloxacin belong to the fluoroquinolone class of antibiotics and are amongst the most commonly prescribed antibiotics. In 2018 and 2019, Food and Drug Administration (FDA) and the European Medicine Agency (EMA) requested that manufacturers harmonize FQ safety information related to neuropsychiatric, aortic dissection, and long-term disability. The authors hypothesize that FDA and EMA epidemiologists support a strong association between these drugs and the three toxicities.

Caveat Medicus: Clinician experiences in publishing reports of serious oncology-associated adverse drug reactions.

Oncology-associated adverse drug/device reactions can be fatal. Some clinicians who treat single patients with severe oncology-associated toxicities have researched case series and published this information. We investigated motivations and experiences of select individuals leading such efforts.

Overview of Pharmacological Considerations in Extracorporeal Membrane Oxygenation.

Extracorporeal membrane oxygenation has become more widely used in recent years. Although this technology has proven to be lifesaving, it is not devoid of complications contributing to significant morbidity and mortality. Nurses who care for patients receiving extracorporeal membrane oxygenation should further their understanding of changes in medication profiles due to complex interactions with the extracorporeal membrane oxygenation circuitry.