Shire’s Prucalopride Brings Real-World CV Safety Data To US FDA Panel, But Will It Be Enough?
European postmarketing epidemiological study results ‘reasonably exclude’ a greater than three-fold increased risk of major adverse cardiovascular events with the constipation drug but, due to potential bias, cannot definitively exclude a possibly unacceptable level of risk, agency says.
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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.
In unanimously endorsing prucalopride for chronic idiopathic constipation, advisory committee seems reassured by extensive data on 5-HT4 agonist’s cardiovascular safety, but some members called for an epidemiological study to assess possible suicidality signal.