Posted by Lou Pilder on February 29, 2012, at 6:49:30
In reply to Saphris and Agranulocytosis - Still No Risk » Lou Pilder, posted by SLS on February 29, 2012, at 5:41:42
> 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
>
> http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM173876.pdf
>
> 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:
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> 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"
>
> http://books.google.com/books?id=hXYLLkgYp2QC&pg=PA968&lpg=PA968&dq=agranulocytosis+rate+population&source=bl&ots=epkArk3kFa&sig=911R4zM8Hl4JSX6547ndoVB1G6Q&hl=en&sa=X&ei=RQpOT4ORN4jk0QGr7-nKAg&ved=0CFgQ6AEwBTgK
>
> "Mortality rates due to clozapine-induced agranulocytosis have been reported to be 0.016% to 0.017%"
>
>
> - ScottScott, You have introduced a good point here in relation to {risk} of death from taking a psychotropic drug.
Now the drug saphris is new on the market for a few years, not like zyprexa that has been taken for 16 years. Zyprexa has over 35,000 reports while saphris has around only 1500 reports.
So when {risk} is computed, there could be drastic changes in the percentages going forward if just a few more reports are cataloged from saphris. To get a good probability number, great numbers of events are needed to have accuracy in the percenatges.
For instance, if I roll the dice 100 times and get only one {snake eyes}, I could think that snake eyes is a 1 to 100 chance, very rare.
But if I roll the dice 10,000 times and record the number of times snake eyes came up, it could approach the real probability of 1 out of 36 . The more times the dice are rolled , the closer to the real probability the event takes.
Now Saphris has only about 1500 reports. That is not enough reports IMO to take a stance on what the rarity is for agranulocytosis to happen. There is one report now, but the dice keep rolling and as we go forward, the stats could change dramatically.
For instance, here is the odds of getting agranulocytosis from taking Zyprexa from 35,000 reports. Now be advised that there are events that are not reported which if they were, the numbers would be greater. The people that make the warnings did put in that other drugs in the class of saphris could cause agranulocytosis. I think that they may have put that in there for now because there could be similar occurances with saphris when 35,000 reports come in. There is a report of agranulocytosis from saphris.
Now you will see that zyprexa has around a 2 1/4 % occurance in the total number of reports. That I intend to show how that is related to this discussion, unless the rule of 3 applies.
Lou
http://ehealthme.com/ds/zyprexa/agranulocytosis
poster:Lou Pilder
thread:1011122
URL: http://www.dr-bob.org/babble/20120221/msgs/1011990.html