Posted by SLS on February 29, 2012, at 5:41:42
In reply to correction- Saphris and Agranulocytosis -risk, posted by Lou Pilder on February 29, 2012, at 4:26:53
Mr. Pilder:
This is the article that you linked to:
http://www.pharmacistactivist.com/2010/January_2010.shtml
Please place here a quote from the article you cited detailing how Saphris was determined to causes agranulocytosis.
-> ""
You managed to find an article that simply paraphrases a section of the Saphris package insert. Similar verbiage appears as standard practice for all neuroleptic antipsychotics as a precaution. It does not indicate that Saphris in particular was observed to produce agranulocytosins. Agranulocytosis is only listed as a class effect.
You can see that section of the package insert here:
http://www.rxlist.com/saphris-drug/side-effects-interactions.htm
You will notice that agranulocytosis does not appear anywhere else on the page. It is not listed as an observed side effect - not even a rare one.
The following document is the briefing report produced by the FDA regarding Saphris (asenapine). There is no mention of agranulocytosis anywhere in the document, including the section on reported adverse events.
FDA Psychopharmacologic Drugs Advisory Committee Meeting
It is actually remarkable that agranulocytosis didn't appear just by chance in the patient population.
Saphris does not appear to cause agranulocytosis. Nor do most other antipsychotics. It appears that the class precaution is the result of observing agranulocytosis in a single drug - clozapine (Clozaril).
Further reading:http://www.ncbi.nlm.nih.gov/pubmed/15851637
"Agranulocytosis is rare but serious. A few drugs account for two thirds of the cases. Our results also provide reassurance regarding the risk associated with a number of newly marketed drugs"
http://www.medicine.ox.ac.uk/bandolier/band136/b136-5.html
For all cases of agranulocytosis for all causes:
"The overall incidence was 5 cases per million per year"
"Mortality rates due to clozapine-induced agranulocytosis have been reported to be 0.016% to 0.017%"
- ScottSome see things as they are and ask why.
I dream of things that never were and ask why not.- George Bernard Shaw
poster:SLS
thread:1011122
URL: http://www.dr-bob.org/babble/20120221/msgs/1011985.html