FDA Review Questions Cardiac, Suicide Risks for Investigational Antipsychotic

Investigational antipsychotic drug sertindole (Serdolect) is effective at treating schizophrenia, but it may lead to sudden cardiac death, according to an FDA review.

The agency released its review in advance of Tuesday's meeting of the Psychopharmacologic Drugs Advisory Committee, which will decide if the drug's cardiovascular risk is an obstacle to FDA approval.

The advisory panel will also consider the sponsor's suicide prevention claim, and whether to recommend to the FDA that the drug is safe and effective. The vote will effectively amount to a recommendation of approval or denial.

Sertindole is already used in other countries to treat schizophrenia.

According to the FDA review, led by psychiatrist Phillip Kronstein, M.D., sertindole is effective in treating schizophrenia, but concerns remain about the drug's potential to prolong the heart's QT interval, which can lead to sudden cardiac death. That same cardiac risk has been seen in other antipsychotic drugs similar to sertindole.

Sertindole is a so-called atypical antipsychotic drug, Its specific mechanism appears to be to inhibit spontaneously active dopamine neurons in the mesolimbic ventral tegmental area without affecting dopamine neurons in the substantial nigra compacta.

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Use of Atypical Antipsychotic Drugs Increases Risk of Sudden Cardiac Death

Patients aged 30 to 74 years who took atypical antipsychotics such as risperidone (Risperdal), quetiapine (Seroquel), olanzapine (Zyprexa), and clozapine (Clozaril) had a significantly higher risk of sudden death from cardiac arrhythmias and other cardiac causes than patients who did not take these medications, according to a study published in the January 15 issue of the New England Journal of Medicine.

"This study provides critical information about the safety of atypical antipsychotics that can be used to make important treatment decisions for patients," said Carolyn M. Clancy, MD, Agency for Healthcare Research & Quality, Rockville, Maryland.

"These findings will help clinicians and patients weigh the risks versus the benefits of these drugs before prescribing them for treatment of depression or other off-label uses for other conditions."

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