It's Back!

In 1998, a British pharma company removed the atypical antipsychotic Serdolect (sertindole) from European markets after reports of sudden cardiac deaths in patients. But, now, the drug is back on the market in the EU. It was just introduced in Estonia and the company plans to roll it out in Scandinavia and Germany very soon. The drug was only approved for schizophrenia. So how is it that a drug that killed people in the 1990s is suddenly back a decade later? Beats the hell out of me. Sadly, I cannot find a single European press account explaining the paradox. Research articles aren't much help either. Here's one wherein some jackass researcher alleges that deaths connected to the drug were over-reported simply because they were reported at all. If a tree falls in the forest.... I won't even attempt to understand that kind of logic. But I will keep poking around because something funny is going on here.

For example, this from the Royal College of Psychiatrists in reference to the drug (and other atypicals, presumably):

"Mortality from causes other than suicide is higher than expected in schizophrenia. Cardiovascular causes are most common, accounting for the majority of the 5% of sudden and unexpected deaths. Most cases have no clear explanation on post-mortem examination (‘sudden unexplained deaths’) and are thought to result from fatal arrhythmias."

And, this from a British medical journal:

"Because of the cardiac problems, even evident within poorly reported studies, at present sertindole should, if possible, be avoided. If sertindole is to be reintroduced, gold-standard evidence of its clinical benefits will need to far outweigh its real risks."

I can find no bronze-standard evidence of its clinical benefits anywhere, so I wonder what the EU was thinking.

As far as I can tell, the drug was never approved for use in the US, and there are no moves on the horizon to land a license here. But, then, we're talking Big Pharma here, so nothing would surprise me. Bipolars and schizophrenics be on guard.

You know, the thing these pharma companies and doctors have got to realize is that there's this little thing out there now called Google Scholar and a lot of patients frustrated by these kinds of meds.