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Association Patterns in Open Data to Explore Ciprofloxacin Adverse Events
1Department of Computer Engineering, Faculty of Engineering and Architecture, Okan University , Istanbul, Turkey.
Background:
Ciprofloxacin is one of the main drugs to treat bacterial infections. Bacterial infections can lead to high morbidity, mortality, and costs of treatment in the world. In this study, an analysis was conducted using the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) database on the adverse events of ciprofloxacin.
Objectives:
The aim of this study was to explore unknown associations among the adverse events of ciprofloxacin, patient demographics and adverse event outcomes.
Methods:
A search of FDA AERS reports was performed and some statistics was highlighted. The most frequent adverse events and event outcomes of ciprofloxacin were listed, age and gender specific distribution of adverse events are reported, then the apriori algorithm was applied to the dataset to obtain some association rules and objective measures were used to select interesting ones. Furthermore, the results were compared against classical data mining algorithms and discussed.
Results:
The search resulted in 6 531 reports. The reports included within the dataset consist of 3 585 (55.8%) female and 2 884 (44.1%) male patients. The mean age of patients is 54.59 years. Preschool child, middle aged and aged groups have most adverse events reports in all groups. Pyrexia has the highest frequency with ciprofloxacin, followed by pain, diarrhoea, and anxiety in this order and the most frequent adverse event outcome is hospitalization. Age and gender based differences in the events in patients were found. In addition, some of the interesting associations obtained from the Apriori algorithm include not only psychiatric disorders but specifically their manifestation in specific gender groups.
Conclusions:
The FDA AERS offers an important data resource to identify new or unknown adverse events of drugs in the biomedical domain. The results that were obtained in this study can provide valuable information for medical researchers and decision makers at the pharmaceutical research field.
Insights
This study analyzed ciprofloxacin adverse events using FDA data, finding pyrexia as the most frequent event and hospitalization as the most common outcome. It also identified specific demographic associations with adverse drug reactions.
Area of Science:
- Pharmacovigilance
- Drug Safety
- Data Mining in Healthcare
Background:
- Ciprofloxacin is a key antibiotic for bacterial infections, which cause significant global morbidity and mortality.
- Analyzing adverse events is crucial for understanding drug safety profiles.
- The U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) database is a valuable resource for drug safety surveillance.
Purpose of the Study:
- To uncover novel associations between ciprofloxacin adverse events, patient demographics, and event outcomes.
- To identify patterns in ciprofloxacin-related adverse events using a large-scale database.
- To provide data-driven insights for pharmaceutical research and clinical decision-making.
Main Methods:
- Extracted and analyzed 6,531 reports from the FDA AERS database concerning ciprofloxacin.
- Performed statistical analysis to determine frequent adverse events and outcomes, stratified by age and gender.
- Applied the Apriori algorithm to discover association rules among adverse events, validating findings with classical data mining techniques.
Main Results:
- Pyrexia, pain, diarrhea, and anxiety were the most frequent adverse events reported with ciprofloxacin.
- Hospitalization was the most common adverse event outcome.
- Significant age and gender-specific differences in adverse event occurrence were observed, with preschool, middle-aged, and elderly groups reporting more events.
- The Apriori algorithm revealed associations between ciprofloxacin and psychiatric disorders, particularly in specific gender groups.
Conclusions:
- The FDA AERS database is instrumental in identifying new or previously unrecognized adverse drug events.
- The study's findings offer critical information for medical researchers and pharmaceutical decision-makers regarding ciprofloxacin safety.
- Understanding demographic associations with adverse events can inform targeted drug safety monitoring and patient management strategies.
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