sertindole

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Because there are safer approved therapies for schizophrenia, and because sertindole is not more effective than any of these other drugs, we believe that the risk of sudden cardiac death is unacceptable and this drug should not be approved.

PharmaGossip 2009

Although sertindole had not been approved by the FDA, marketing in Europe was approved in

PharmaGossip 2009

The pre-specified primary endpoint of all-cause mortality was not significantly different with these two drugs, but the study failed to exclude a 50\% increase in mortality with sertindole using conventional 95\% confidence intervals.

PharmaGossip 2009

The increased risk of sudden cardiac death with sertindole presents a significant public health danger, and it is hard to justify tolerating this risk when this drug is no more effective than other approved therapies for schizophrenia.

PharmaGossip 2009

Much more worrisome, sertindole was associated with a fivefold greater risk of sudden cardiac death than risperidone (hazard ratio 5.1, 95\% confidence interval 1. 5-17.9).

PharmaGossip 2009

The panel voted 8-2 (three panelists abstained from the vote) in favor of FDA approval for Serdolect (sertindole) among certain patients (such as those who do not respond to other treatments) despite concerns about heart-related risks.

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On April 7, 2009, the Psychopharmacologic Drugs Advisory Committee met to discuss the use of sertindole in schizophrenia.

PharmaGossip 2009

The panel voted 8-2 (three panelists abstained from the vote) in favor of FDA approval for Serdolect (sertindole) among certain patients (such as those who do not respond to other treatments) despite concerns about heart-related risks.

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The Sertindole Cohort Prospective (SCoP) Study was conducted to measure the risk of sudden cardiac death in patients with schizophrenia by randomizing nearly 10,000 patients to either sertindole or risperidone.

PharmaGossip 2009