PATIENTS IGNORE FDA'S BLACK BOX Rx LABELS

Published Online: Sunday, January 1, 2006

The increasingly critical role of pharmacists in helping to curb patient medication errors was underscored by new research findings that too many consumers are ignoring—or misinterpreting— FDA "black box" label warnings for prescription drugs. The study, published in the Journal of Pharmacoepidemiology and Drug Safety, found that compliance with the FDA label warnings varies significantly from drug to drug.

Although the researchers identified a high level of compliance with Rx label warnings that caution against taking the medication while pregnant, they found that patients were significantly less likely to heed prescription labeling calling for regular follow-up diagnostic tests by users of a drug.

Additionally, the study findings suggest that specific warnings are more effective in securing patient compliance than vaguely worded ones. In releasing the new data, the researchers said that pharmacists and regulators "need to find out how we can communicate the content of the warning clearly to clinicians and patients."



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