Adverse events reported to the U.S. Food and Drug Administration Adverse Event Reporting System for tisagenlecleucel.

The U.S. Food and Drug Administration (FDA) approved the first chimeric antigen receptor T-cell therapy, tisagenlecleucel, in August 2017.

Adverse Events Associated with Use of Digoxin Immune Fab Reported to the US Food and Drug Administration Adverse Event Reporting System, 1986-2019.

Background: Digoxin immune fab products, DigiBind and DigiFab, are antidotes for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose. Although approved by the US Food and Drug Administration (FDA) in 1986 (DigiBind) and 2001 (DigiFab), there remains a paucity of literature describing the safety of these products in the postmarketing setting.

Objective: We sought to assess US adverse event (AE) reports submitted to the FDA Adverse Event Reporting System (FAERS) for DigiBind and DigiFab in the postmarketing period.

Case series of reports of pruritus and sipuleucel-T submitted to the Food and Drug Administration Adverse Event Reporting System.

Sipuleucel-T, an autologous active cellular immunotherapy, is indicated for the treatment of asymptomatic or minimally symptomatic castration-resistant prostate cancer. The U.S.

Adverse events after anthrax vaccination reported to the Vaccine Adverse Event Reporting System (VAERS), 1990-2007.

During the period March 1, 1998 to January 14, 2007, approximately 6 million doses of Anthrax vaccine adsorbed (AVA) vaccine were administered. As of January 16, 2007, 4753 reports of adverse events following receipt of AVA vaccination had been submitted to the Vaccine Adverse Event Reporting System (VAERS). Taken together, reports to VAERS did not definitively link any serious unexpected risk to this vaccine, and review of death and serious reports did not show a distinctive pattern indicative of a causal relationship to AVA vaccination.

Transfusion-transmitted Klebsiella pneumoniae fatalities, 1995 to 2004.

Transfusion-transmitted bacterial sepsis is the third most common cause of transfusion-related fatalities reported to the Food and Drug Administration. Between October 1, 1995, and September 30, 2004, there were 665 reported transfusion fatalities. Eighty-five (13%) deaths were due to transfusion-transmitted bacterial infections, of which 58 (68%) were due to gram-negative organisms.