Prescription medication labels often leave out crucial information contained in Food and Drug Administration (FDA) review documents. The Robert Wood Johnson Foundation’s Pioneer Portfolio funded the development of “Prescription Drug Facts Boxes” that address the shortcomings of current medication labels.

Before approving a drug, the FDA examines the results of preclinical trials and presents its findings in detailed reports. Once the medication receives FDA approval, the drug company and the FDA must then agree on an acceptable label. Medication labels become key sources of prescribing information for professional clinicians. This commentary presents evidence that several medications currently on the market have inadequate labels. The authors cite data found in FDA reports that were missing from the labels of three medications: Zometa, Lunesta and Rozerem.

Key Findings:

• FDA reports express varying degrees of certainty about the effectiveness of approved drugs. Medication labels often do not reflect uncertainties contained in FDA reports.
• Medication labels omit information regarding an approved drug’s specific harms or benefits.

The FDA is considering adopting "Prescription Drug Facts Boxes;" to supply crucial information now absent from many drug labels.