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Adverse Drug Reaction Study Finds Inconsistencies in Product Information Between USA and Europe


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A recent research study was conducted to compare the consistency of adverse drug reaction (ADR) data in the publicly available product information for brand drugs between the USA and Europe in order to assess the usefulness of information for prescribers and patients.

A comparison of product information documents for antidepressants and anticonvulsants marketed simultaneously by the same pharmaceutical company in the USA and Europe was reviewed.

The study concluded that product information documents contained a large number of ADRs, but lacked contextual data and information important to patients and prescribers, such as duration, severity, and reversibility. Additionally, the ADR profile was found to be inconsistently reported between the USA and Europe, for the same drug.

Publically available drug product documents can be valuable and vital sources of harm information, but data included in these studied drugs were found to be inconsistent and not usefully presented.

In order for prescribers to provide informed risk-benefit advice across competing drug therapies to patients, they need access to comprehensible and reliable ADR information.

Read the full research study here.

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