Fostamatinib-Induced Hepatomegaly: A Novel Signal Identified Through US Food and Drug Administration Adverse Event Reporting System (FAERS) Database
Author(s)
Akshay R. Gawai, Mpharm.
Student, M S Ramaiah University Of Applied Sciences, Bengaluru, India.
Student, M S Ramaiah University Of Applied Sciences, Bengaluru, India.
OBJECTIVES: Fostamatinib is an oral prodrug that is rapidly converted to its active metabolite R406, a spleen tyrosine kinase (SYK) inhibitor. Fostamatinib has been approved for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who have had an insufficient response to previous therapy. By inhibiting SYK, fostamatinib reduces platelet destruction and modulates autoimmune activity, making it a promising candidate for conditions involving dysregulated immune responses. Signal detection and disproportionality analysis helps to identify an unidentified adverse drug reaction (ADR).
METHODS: An in-depth case/non-case retrospective disproportionality analysis was conducted in the publicly available FAERS database for Fostamatinib. Fostamatinib was approved by FDA in the year 2018 (April). All the reports of Fostamatinib were analysed. The investigation delved into the USFDA adverse event reporting system database, employing the top 2 data mining algorithms in widespread use for signal detection such as Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) from the Open Vigil database. A value of PRR≥1 and ROR-1.96SE>1 was considered as positive signal.
RESULTS: Among the total 27,634,809 FAERS reports, 54,173 were related to Fostamatinib. The Fostamatinib reports (45,909) were classified as serious and many fatal reactions were reported. The total number of adverse events reported for Hepatomegaly is 17. On analysis, data mining algorithms showed the results as ROR of 3.42(2.122; 5.511) and PRR of 3.418 (2.121; 5.507). The ROR and PRR confirmed the occurrence of the adverse reaction Hepatomegaly for Fostamatinib.
CONCLUSIONS: This study revealed that Hepatomegaly is likely to occur among patients administered with Fostamatinib. The authors conclude that the health care practitioners should monitor for the occurrence of Hepatomegaly among patients administered with Fostamatinib. The epidemiological studies should be conducted to validate the identified novel signal among a larger population.
METHODS: An in-depth case/non-case retrospective disproportionality analysis was conducted in the publicly available FAERS database for Fostamatinib. Fostamatinib was approved by FDA in the year 2018 (April). All the reports of Fostamatinib were analysed. The investigation delved into the USFDA adverse event reporting system database, employing the top 2 data mining algorithms in widespread use for signal detection such as Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) from the Open Vigil database. A value of PRR≥1 and ROR-1.96SE>1 was considered as positive signal.
RESULTS: Among the total 27,634,809 FAERS reports, 54,173 were related to Fostamatinib. The Fostamatinib reports (45,909) were classified as serious and many fatal reactions were reported. The total number of adverse events reported for Hepatomegaly is 17. On analysis, data mining algorithms showed the results as ROR of 3.42(2.122; 5.511) and PRR of 3.418 (2.121; 5.507). The ROR and PRR confirmed the occurrence of the adverse reaction Hepatomegaly for Fostamatinib.
CONCLUSIONS: This study revealed that Hepatomegaly is likely to occur among patients administered with Fostamatinib. The authors conclude that the health care practitioners should monitor for the occurrence of Hepatomegaly among patients administered with Fostamatinib. The epidemiological studies should be conducted to validate the identified novel signal among a larger population.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EPH113
Topic
Clinical Outcomes, Epidemiology & Public Health, Real World Data & Information Systems
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Gastrointestinal Disorders, No Additional Disease & Conditions/Specialized Treatment Areas