Reported Characteristics of Anaphylaxis Associated With Glatiramer Acetate: A Pharmacovigilance Analysis of the FDA and Canadian Databases
Tailei Nie, Hongyu Liu, Chuanxu Cheng, Jian Li, Jiajing Lu · 2026
Read Reported Characteristics of Anaphylaxis Associated With Glatiramer Acetate: A Pharmacovigilance Analysis of the FDA and Canadian Databases by Tailei Nie, Hongyu Liu, Chuanxu Cheng, Jian Li, Jiajing Lu (2026) in the Tower of Babel, a free online library of public-domain works preserved in clean, searchable text. No sign-up. The full text is served as a plain-text file at a predictable URL, where text is present: https://antarctic-labs.com/tower-of-babel/PMC13428025.txt.
Description
Tailei Nie and colleagues characterise reports of anaphylaxis, a severe allergic reaction, linked to glatiramer acetate, a drug used for multiple sclerosis. Their 2026 pharmacovigilance study mines the United States FDA adverse event database and the Canadian vigilance database after regulators required a boxed warning for the drug.
The FDA database held 9,816 relevant reports with 29 statistically significant safety signals, and the association with anaphylaxis held up across age, weight, sex, and reporter groups. Younger patients accounted for a higher share of serious reports. Reported reactions tended to appear earlier rather than later after treatment started, with median onset around five to six months depending on signal priority. The Canadian database added 711 reports, including respiratory arrest, a signal not seen in the FDA data. The authors frame the results as groundwork for future validation studies.
Catalog record
| CREATOR | Tailei Nie, Hongyu Liu, Chuanxu Cheng, Jian Li, Jiajing Lu |
|---|---|
| YEAR | 2026 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 36 KB |
| LICENSE | https://creativecommons.org/licenses/by/4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |