FDA' s Advancing Regulatory Science: TRALI - Transfusion-Related Acute Lung Injury

Recommendation
17/18 September 2025
An Overview and Insight in Pharmaceutical Biotechnology
End of March, scientists from the Food and Drug Administration, Silver Spring, Maryland, Acumen LLC, Burlingame, California, and Centers for Medicare & Medicaid Services, Baltimore, Maryland published their current data on Transfusion-Related Acute Lung Injury (TRALI) occurrence and risk factors among the U.S. elderly.
They claim to have collected data during 2007 through 2011 and show that Transfusion-related acute lung injury (TRALI) is a leading cause of transfusion-related deaths in the U.S. It occurs mostly within six hours of blood transfusion and the l eading hypothesis suggests the cause is substances released from activated neutrophils.
Following some of the findings:
- 2,556 TRALI diagnoses reported among 11,378,264 higher rate of blood transfusions among the inpatient transfusion stays for elderly Medicare beneficiaries: elderly 22.46/100,000 stays increased
- TRALI rates were higher for platelet- and plasma-containing transfusions
- TRALI rates increased by year of the study (2007-2011) and number of units
- Significantly higher odds of TRALI among specific groups
» persons 65 to 79 years vs. older than 79 years, with TRALI risk declining with advancing age
» females vs. males
» white versus nonwhite
» certain medical histories - post-inflammatory pulmonary fibrosis
- cancers of blood forming tissues
- pulmonary insufficiency following trauma or surgery
- tobacco use
- transfusion
Read more about the TRALI data direct in Advancing Regulatory Science.
Related GMP News
25.06.2025Is Knowledge Management a Part of the Pharmaceutical Quality System?
11.06.2025Swissmedic differentiates GMP Scope for Manufacturing and Preparation for Administration
28.05.2025A View on the EU Critical Medicines Act to secure Pharma Supply Chains
20.05.2025Summary Data on Registration and Listing of Cosmetic Facilities and Products
07.05.2025FDA is extending its Quality Management Maturity Programme
30.04.2025FDA Warning Letter on missing Audit Trails and Raw Data Review