Comments: FDA Reviewer Calls About-To-Be-Approved Antipsychotic Unsafe
Ive written about this too, and I think everyone who blogs should. This drug is also going to be used for BP1.
"Death from asenapine(Saphris) can come suddenly and without warning in otherwise young healthy individuals due to arrhythmias or strokes." -page 895/1067, June 18, 2008"
That is from page 895 in the 1067 page book of materials the FDA committee reads before approval of the drug.
http://bipolarsoupkitchen-stephany.blogspot.com/2009/07/saphris-asenapine-new-schizophrenia.html
It brings back to the surface Thomas Laughren who is already inferring the approval will happen according to news articles and not to forget how his name is on ghostwritten materials pertaining to antipsychotics...and more.
Trusting this medication would be like selling your soul to the devil based on lack of truth and unethical behavior--the FDA approval process is tainted in my opinion.
Posted by Stephany at July 29, 2009 11:16 AM
"...off-label marketed for depression and agitation..."
Don't forget their close friend "insomnia" and its cousin "anxiety."
Posted by SteveBMD at July 29, 2009 11:29 AM
This is just sickening. The whole approval process RE: psychotropic drugs is such a scam. I said it before and I'll say it again, you couldnt't PAY me to take saph"CrisIS"!!!!
Posted by WomanofHope at July 29, 2009 02:16 PM
And you can be sure they will soon "Abilify" Saphris and market it as an adjunctive therapy for depression.
I.e., to help the patient wind down from the psycho-pharm brain-wreck that is Cymbalta.
Posted by SteveM at July 29, 2009 06:54 PM
SteveBMD, great points. As one who is currently suffering from severe insomnia thanks to psych med withdrawal, hell will freeze over before I take an antipsychotic for sleep.
Posted by AA at July 30, 2009 05:26 AM
http://shearlingsplowed.blogspot.com/2009/07/salmons-latest-asenapine-chronicles.html
Looks like it's going to get approval, read this link there is an insider in the comment section
Posted by Stephany at July 30, 2009 06:12 PM
"Outside advisers to the Food and Drug Administration voted 9-1, with two abstentions, that the drug’s benefits outweighed its risks for adults with schizophrenia, and 12-0 in favor of its use in treating manic or mixed episodes of bipolar disorder."
I may be sceptical about this drug. However, if I were on the panel, I would have voted "yes" for it as well. The fundamental problem is in how the critical questions were formulated. For example: "Is asenapine safe for acute [meaning short-term] treatment of schizophrenia?" -- I would be forced to answer "yes". But I would be thinking,- yea, it may be "safe" for a couple of months, but how often do you see schizophrenia that requires short-term treatment? What the FDA should have done is to rule that drugs for chronic conditions can be approved only with long-term safety trials. Unfortunately, the FDA fell short of this.
Another problem is that there are no "safe" drugs for schizophrenia. They all have nasty side effects. It has even been argued that asenapine was safer than Zyprexa because it didn't cause as much weight gain. I am asking myself, if we do not approve asenapine, what kind of drug could be approved for schizophrenia? -- Most likely, setting strict criteria for safety will result in no new drugs for schizophrenia.
Only time will show how good/bad asenapine is.
Posted by TSC at July 31, 2009 04:05 AM
Saphris was approved by the FDA August 14, 2009 for SZ and bipolar use.
http://www.fiercebiotech.com/story/schering-gains-blockbuster-saphris-approval/2009-08-14
"Schering-Plough has won FDA approval of Saphris, a likely blockbuster antipsychotic, just ahead of its acquisition by Merck. The drug is now approved to treat episodes related to bipolar I disorder as well as acute schizophrenia."
Let's not forget:
The FDA Psychopharmacologic Drugs Advisory Committee meeting briefing book (1067 pages)
"Death from asenapine(Saphris) can come suddenly and without warning in otherwise young healthy individuals due to arrhythmias or strokes." -page 895/1067, June 18, 2008
Thanks to the useless FDA!
Posted by Stephany at August 14, 2009 08:31 PM