Adverse drug events (ADEs) are a major cause of morbidity and mortality (1, 2) . However, postmarketing surveillance systems are passive, and reporting is generally not mandated (2) . Thus, many ADEs go unreported, and it is difficult to estimate and/or anticipate side effects that are unknown at the time of approval. ADEs that are reported to the FDA tend to be severe, and potentially common, but less serious side effects are more difficult to characterize and document. Drugs with a high risk of harm outweighing the therapeutic value have recently been subjected to a greater level of interest with the Food and Drug Administration's Risk Evaluation and Mitigation Strategies (REMS) (3). However, no rapid method to detect if the REMS produce the desired effect and assessment of the impact is conducted by the drug manufacturer.