Study on Drug-Induced Coagulopathies Using FDA Data
Author Information
Author(s): Lu Yanjun, Xu Qian, Zhu Shita
Primary Institution: Pharmacy Department, Xiamen Fifth Hospital, Xiamen, Fujian, China
Hypothesis
This study aims to investigate adverse drug reaction signals associated with coagulopathies through data mining using the Adverse Event Reporting System (FAERS) of the US Food and Drug Administration.
Conclusion
Multiple drugs are associated with an increased risk of coagulopathies, highlighting the need for proactive analysis to enhance clinical monitoring.
Supporting Evidence
- 40,545 reports related to coagulopathies were retrieved from the FAERS database.
- 24 out of the top 30 drugs analyzed exhibited positive signals in risk analysis.
- The top five drugs associated with coagulopathies were gemcitabine, busulfan, anti-thymocyte globulin, tacrolimus, and etonogestrel and ethinylestradiol vaginal ring.
Takeaway
Some medicines can make it hard for your blood to clot, which can cause serious bleeding problems. This study helps doctors know which drugs to watch out for.
Methodology
Data from the FAERS database was analyzed using reporting odds ratio (ROR), proportional reporting ratio (PRR), and Bayesian confidence propagation neural network (BCPNN) to identify adverse drug reaction signals.
Potential Biases
Potential bias due to reliance on spontaneous and voluntary reports which may be influenced by recent findings or media coverage.
Limitations
The study only establishes associations between drugs and adverse events without definitive proof of causation, relies on voluntary reporting which may be biased, and does not account for the impact of concomitant drugs.
Participant Demographics
The reports included a slightly higher proportion of females (46.2%) than males (44.1%), with the majority of reports coming from the United States.
Statistical Information
Confidence Interval
95% CI for ROR values provided in the results.
Digital Object Identifier (DOI)
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