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Background Good information on the harm of a drug is vital to inform risk-benefit decisions and undertake robust cost effectiveness analysis. Clinical trials reported in peerreviewed articles are not useful for this purpose [1,2]. Regulators require pharmaceutical companies to produce product information documents (Europe:SmPC, US:USPI). These documents contain comprehensive and valuable publicly available information on the known harm of a drug and have the potential to inform important risk-benefit decisions. We reviewed the usefulness of the data presented and compared the harm profile reported in documents for brand drugs marketed in Europe and the US.

Usability and consistency of harm information in drug product descriptions: a matched comparison of data between the United States (US) and Europe