FDA Reviewer Calls About-To-Be-Approved Antipsychotic Unsafe
There was a flurry of attention yesterday in the business press around the still-awaiting-approval drug Saphris (asenapine), an atypical antipsychotic made by Schering-Plough. In briefing documents, the FDA’s psychiatry products chief Thomas Laughren said that the company had demonstrated effectiveness in trials of the drug as a treatment for schizophrenia and that it was about as safe as other atypicals. Which is to say not very safe at all, given the well-known problems with drugs like Zyprexa and Seroquel.
It sounds as if the drug is on its way to FDA approval for schizophrenia.
What’s troubling to me is this posting from the blog Shearlings Got Plowed, which tracks problems at Schering-Plough, identifies an internal FDA email showing an FDA reviewer who in 2008 recommended that the drug not be approved, cited safety problems with the drug (hypertension, cardiac effects) and stated that officials at S-P knew about “toxicity and specifically tried to prevent our [FDA's] detecting it.”
So this sounds like a perfect drug for FDA approval and a perfect opportunity to repeat the misdeeds of the other atypicals: approval for schizophrenia, drug declared best thing since sliced bread, drug off-label marketed for depression and agitation, a few years later the tales of patients dying and being injured show up, and so on. I cannot wait.
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