FAEMS reports do not establish which of the following?

• A. Probability
• B. Correlation
• C. Causation
• D. Sequence

Answer: (C)

Spontaneous adverse-event reports are useful for spotting potential links and for noting the order of events, but they don’t prove that a drug caused the event. They’re subject to biases, confounding factors, and lack of controlled comparison, so while they can suggest an association and help establish that the adverse event occurred after exposure (a temporal sequence), they cannot establish causation by themselves. To prove causation, you’d need stronger evidence across multiple cases and study designs, showing a consistent, biologically plausible link with ruling out alternative explanations (for example, dechallenge/rechallenge data, dose–response relationships, and controlled studies).