1) The study assessed 227 FDA-approved Medication Guides to evaluate their readability, suitability, and patients' ability to understand them. It found the average reading level was 10th-11th grade. 2) A survey of 449 patients found they scored an average of 53% on comprehension questions about 3 Medication Guides. Comprehension was strongly linked to literacy level. 3) The study concludes Medication Guides in their current form are failing to convey important risk information to patients and reforms are needed to make them more readable and patient-centered.