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Real-World Evidence: US FDA’s Prucalopride Review Shows Datasets' Utility And Limitations

Executive Summary

A European pharmacoepidemiology study helped reassure advisory committee members about the constipation drug’s cardiovascular safety, but confounding factors limited interpretability of the results and information about the study population’s racial makeup was lacking; nevertheless, panelists urged a similar study be conducted to assess potential carcinogenic and psychiatric risks.

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