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responses to medicine. Different individuals may respond to medication in different ways. The
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- Potential risks highlighted by drug safety analysis must be balanced against the clinical benefit attained
by the use of a pharmaceutical product in a given clinical situation. Nothing in these analyses is intended
to influence the practice of medicine, nor to weigh the benefits of one product over another.
- Whether the reporting ratio of an adverse event is high enough to influence the decision to use a given
product or products can only be determined by a complete analysis of the benefits, risks, and therapeutic
- Use of the publicly available FAERS data does not imply endorsement or agreement of the findings
by the FDA Center for Drug Evaluation and Research.
- There are many factors that can influence how the adverse events are reported in the FAERS database
and may impact the resulting safety signal. These include but are not limited to: publicity and media
attention, litigation, length of time drug is on the market, whether the event in question has been
previously attributed to the drug, the source of the report, etc.
- FAERS data must often be "cleaned" prior to analysis. This process may include de-duplication,
reconciliation of misspelled product names, mapping of adverse events terms, and other manipulations
which could introduce bias into the analysis.