FDA cardiac concerns on Lundbeck's Serdolect

The US Food and Drug Administration posted documents on its web site stating that Danish drugmaker H Lundbeck's Serdolect (sertindole)  appears effective against schizophrenia but noted concerns that the  drug may increase the risk of sudden cardiac death.

In briefing documents released ahead of an upcoming meeting of a panel  of outside experts, FDA officials concluded that the overall safety  profile for this drug appears to be similar to other atypical  antipsychotics, with the exception of a potential to prolong the QTc  interval.

To address this question, Lundbeck conducted a large simple trial, the  SCoP study, comparing Serdolect to Johnson & Johnson's Risperdal  (risperidone), another atypical antipsychotic drug, on all-cause  mortality.