Coagulation factors, notably vonicog alfa (ROR 43.69) and pegylated factor VIII (ROR 26.93), and chamomile (ROR 20.10), were strongly associated with head injury reports in the FAERS database.
Observational (n=26,485)
Which drugs are associated with disproportionate reporting of head injuries in the FAERS database?
Coagulation factor therapies and chamomile are associated with disproportionately high reporting of head injuries in the FAERS database, though this likely reflects confounding by indication for coagulation factors.
Odds Ratio: 43.69
OBJECTIVE: This study aimed to identify and characterize drugs associated with reports of head injury through a comprehensive analysis of the FDA Adverse Event Reporting System (FAERS) database. METHODS: A retrospective disproportionality analysis was conducted on FAERS reports from 2004 to 2023. Cases were identified using a single Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term: "Head Injury" (PT code 10019196). Four disproportionality methods-Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS)-were used to detect significant safety signals. RESULTS: Analysis of 26,485 head injury reports revealed a rising trend over time, with 84.12% being serious and 8.51% fatal. Strongest signals were detected for coagulation factors, notably vonicog alfa (ROR: 43.69) and pegylated factor VIII (ROR: 26.93). Chamomile also showed a significant association (ROR: 20.10). In contrast, warfarin had the highest report count (n = 429) but only a moderate signal strength (ROR: 6.77). CONCLUSION: This large-scale pharmacovigilance study identifies a strong association between coagulation factor therapies and reports of head injury. This signal most plausibly reflects confounding by indication rather than a direct prothrombotic mechanism. It also raises safety concerns regarding chamomile. These findings highlight the need for increased clinical vigilance and further investigation into these potential risks.
Guo et al. (Mon,) conducted a observational in Head Injury (n=26,485). Coagulation factors and chamomile was evaluated on Head injury reports (ROR 43.69). Coagulation factors, notably vonicog alfa (ROR 43.69) and pegylated factor VIII (ROR 26.93), and chamomile (ROR 20.10), were strongly associated with head injury reports in the FAERS database.