A safety report can document that someone suspected a medicine contributed to an event. Whether the medicine caused it is a separate question. Ammendolia and colleagues examined serious reports involving CBD licensed as an antiseizure medicine in EudraVigilance, a European database for monitoring suspected adverse reactions.
Why report frequency differs from incidence
Frequently reported categories included worsening epilepsy, hepatic disorders, lack of efficacy and somnolence. Their frequency describes the reports captured in the analysis. To estimate incidence, researchers would need to know how many people received the medicine and ascertain outcomes consistently across that population. Reports can also vary in how much information they contain about other medicines, underlying illness and the timing of symptoms.
For a case review, the database can identify events that have been reported before. Evaluating the individual event requires the medical timeline, concurrent treatments and other potential explanations. A report count cannot supply those case details.
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