Assessment of Excess Risk for Causation Analysis

In a case involving a drug withdrawn from the market because of alleged adverse events, we developed an epidemiological model to assess causation using the FDA's MedWatch spontaneous adverse events database. We compared data associated with the drug in question with data on a comparator drug in the same therapeutic class. After controlling for possibly confounding factors (e.g., patient demographics, medical profiles, and drug use histories), we evaluated excess risk of an adverse event for the patients in question.