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

 
• By Sue Sutter

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.

hand touching screen with medical data

The US FDA advisory committee review of Shire PLC’s constipation drug Motegrity (prucalopride) highlighted both the possibilities and limitations inherent in using existing real-world datasets in the regulatory setting.

Although results from a pharmacoepidemiology study using European health records and claims databases helped reassure advisory committee members as to...

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