Healthy Skepticism Library item: 16109

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

FDA Reviewer on Asenapine: 'Schering-Plough Knew About this Toxicity and Specifically Tried to Prevent FDA Detecting it. . . .'
Shearlings Got Plowed (blog) 2009 Jul 29
http://shearlingsplowed.blogspot.com/2009/07/fda-reviewer-on-asenapine-schering.html

Abstract:

May 16, 2008

. . . .changing my recommendation for Asenapine to non-approval. . . .

information in the review indicates that Asenapine causes pulmonary arterial hypertension and cardiac effects. . . .

the sponsor [Schering-Plough] knew about this toxicity and specifically tried to prevent our [FDA’s] detecting it. . . .