![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 72 to 96 of 96. Go back in thread:
Posted by Lou Pilder on February 27, 2012, at 22:57:14
In reply to Lou's reply-agranulocytosis » SLS, posted by Lou Pilder on February 27, 2012, at 22:54:00
> > Not good enough.
> >
> > Try again.
> >
> > Or not.
> >
> > There is only one report to the FDA according to the webpage you cited? I don't believe this website. Why should I? There is no way to verify their claims. Even if this single report exists, you really helped to make a case for the possibility that you exaggerate.
> >
> > Do you know the difference between misinformation and disinformation? Just curious.
> >
> > Please feel free to ask me any questions that you would like to have answered along this thread.
> >
> >
> > - Scottt
>
> Scott,
> Saphris is a newer drug so the reports are not many yet as a drug like Prozac. Neutropenia is more eventfull than agranulocytosis, but as more time runs there could be more reports of that event.
> Now what is the chemical concerning receptors are the matabolites. This could change things a bit...
> Now here is a report that I think could be of help here. I have the report on deaths with saphris in the trials and will put that together later.
> Lou
> http://circ.ahjournals.org/content/1022/23/2836.full
corrected:
http://circ.ahjournals.org/content/102/23/2836.full
Posted by Lou Pilder on February 27, 2012, at 23:02:28
In reply to correction- Lou's reply-agranulocytosis, posted by Lou Pilder on February 27, 2012, at 22:57:14
> > > Not good enough.
> > >
> > > Try again.
> > >
> > > Or not.
> > >
> > > There is only one report to the FDA according to the webpage you cited? I don't believe this website. Why should I? There is no way to verify their claims. Even if this single report exists, you really helped to make a case for the possibility that you exaggerate.
> > >
> > > Do you know the difference between misinformation and disinformation? Just curious.
> > >
> > > Please feel free to ask me any questions that you would like to have answered along this thread.
> > >
> > >
> > > - Scottt
> >
> > Scott,
> > Saphris is a newer drug so the reports are not many yet as a drug like Prozac. Neutropenia is more eventfull than agranulocytosis, but as more time runs there could be more reports of that event.
> > Now what is the chemical concerning receptors are the matabolites. This could change things a bit...
> > Now here is a report that I think could be of help here. I have the report on deaths with saphris in the trials and will put that together later.
> > Lou
> > http://circ.ahjournals.org/content/1022/23/2836.full
> corrected:
> http://circ.ahjournals.org/content/102/23/2836.fullcorrection:
http://circ.ahajournals.org/content/102/23/2836.full
Posted by Solstice on February 28, 2012, at 11:34:47
In reply to corection: correction- Lou's reply-agranulocytosis, posted by Lou Pilder on February 27, 2012, at 23:02:28
Lou -
I guess you are aware that your link's Clinical Investigation reiterates what Scott said - that since Saphris is not activating the 5-HT2b receptors, it is not implicated in agranulocytosis.
Solstice
> > > Scott,
> > > Saphris is a newer drug so the reports are not many yet as a drug like Prozac. Neutropenia is more eventfull than agranulocytosis, but as more time runs there could be more reports of that event.
> > > Now what is the chemical concerning receptors are the matabolites. This could change things a bit...
> > > Now here is a report that I think could be of help here. I have the report on deaths with saphris in the trials and will put that together later.
> > > Lou
> > > http://circ.ahjournals.org/content/1022/23/2836.full
> > corrected:
> > http://circ.ahjournals.org/content/102/23/2836.full
>
> correction:
> http://circ.ahajournals.org/content/102/23/2836.full
Posted by Lou Pilder on February 28, 2012, at 12:27:57
In reply to Re: corection: correction- Lou's reply-agranulocytosis » Lou Pilder, posted by Solstice on February 28, 2012, at 11:34:47
> Lou -
>
> I guess you are aware that your link's Clinical Investigation reiterates what Scott said - that since Saphris is not activating the 5-HT2b receptors, it is not implicated in agranulocytosis.
>
> Solstice
>
>
>
> > > > Scott,
> > > > Saphris is a newer drug so the reports are not many yet as a drug like Prozac. Neutropenia is more eventfull than agranulocytosis, but as more time runs there could be more reports of that event.
> > > > Now what is the chemical concerning receptors are the matabolites. This could change things a bit...
> > > > Now here is a report that I think could be of help here. I have the report on deaths with saphris in the trials and will put that together later.
> > > > Lou
> > > > http://circ.ahjournals.org/content/1022/23/2836.full
> > > corrected:
> > > http://circ.ahjournals.org/content/102/23/2836.full
> >
> > correction:
> > http://circ.ahajournals.org/content/102/23/2836.full
>
> Solstice,
In regards to accepting or not as to if one taking Saphris could get agranulocytosis or not, here is a link tthat could be helpful to accepting or not that ine could or could not get agranuloocytosis. Then we could go from there.
Lou
http://doublecheckmd.com/EffectsDetail.do?dname=167374&eid=3093
Posted by Lou Pilder on February 28, 2012, at 12:36:05
In reply to Lou's reply-agranulocytosis-cases » Solstice, posted by Lou Pilder on February 28, 2012, at 12:27:57
> > Lou -
> >
> > I guess you are aware that your link's Clinical Investigation reiterates what Scott said - that since Saphris is not activating the 5-HT2b receptors, it is not implicated in agranulocytosis.
> >
> > Solstice
> >
> >
> >
> > > > > Scott,
> > > > > Saphris is a newer drug so the reports are not many yet as a drug like Prozac. Neutropenia is more eventfull than agranulocytosis, but as more time runs there could be more reports of that event.
> > > > > Now what is the chemical concerning receptors are the matabolites. This could change things a bit...
> > > > > Now here is a report that I think could be of help here. I have the report on deaths with saphris in the trials and will put that together later.
> > > > > Lou
> > > > > http://circ.ahjournals.org/content/1022/23/2836.full
> > > > corrected:
> > > > http://circ.ahjournals.org/content/102/23/2836.full
> > >
> > > correction:
> > > http://circ.ahajournals.org/content/102/23/2836.full
> >
> > Solstice,
> In regards to accepting or not as to if one taking Saphris could get agranulocytosis or not, here is a link tthat could be helpful to accepting or not that ine could or could not get agranuloocytosis. Then we could go from there.
> Lou
> http://doublecheckmd.com/EffectsDetail.do?dname=167374&eid=3093
>
> correction:
http://doublecheckmd.com/EffectsDetail.do?dname=Saphris&sid=167374&eid=3093
Posted by Lou Pilder on February 28, 2012, at 13:51:02
In reply to correction: Lou's reply-agranulocytosis-cases, posted by Lou Pilder on February 28, 2012, at 12:36:05
> > > Lou -
> > >
> > > I guess you are aware that your link's Clinical Investigation reiterates what Scott said - that since Saphris is not activating the 5-HT2b receptors, it is not implicated in agranulocytosis.
> > >
> > > Solstice
> > >
> > >
> > >
> > > > > > Scott,
> > > > > > Saphris is a newer drug so the reports are not many yet as a drug like Prozac. Neutropenia is more eventfull than agranulocytosis, but as more time runs there could be more reports of that event.
> > > > > > Now what is the chemical concerning receptors are the matabolites. This could change things a bit...
> > > > > > Now here is a report that I think could be of help here. I have the report on deaths with saphris in the trials and will put that together later.
> > > > > > Lou
> > > > > > http://circ.ahjournals.org/content/1022/23/2836.full
> > > > > corrected:
> > > > > http://circ.ahjournals.org/content/102/23/2836.full
> > > >
> > > > correction:
> > > > http://circ.ahajournals.org/content/102/23/2836.full
> > >
> > > Solstice,
> > In regards to accepting or not as to if one taking Saphris could get agranulocytosis or not, here is a link tthat could be helpful to accepting or not that ine could or could not get agranuloocytosis. Then we could go from there.
> > Lou
> > http://doublecheckmd.com/EffectsDetail.do?dname=167374&eid=3093
> >
> > correction:
> http://doublecheckmd.com/EffectsDetail.do?dname=Saphris&sid=167374&eid=3093
>
> Solstice,
Now in relation to blood disorders that could cause death dfrom taking Saphris, as to if the cause of death is neutropenia or agranulocytosis, is an ongoing subject of research. I have shown one case of agranulocytosis and there are cases of neutropenia, that could also cause death.
Now here is a link to that Saphris has had people that take it result in death.
My original concern here was to show the chemical structure of saphris and then others could deceide if saphris is a new drug, or a knock-off of an old drug, on their own.
Now be adviced that Mr. Hsiung has posted here a prohibition to me that prohibits me from showing things from a particular era of time involving the political party then, that if the prohibition was not made to me, I think that lives could be saved because people wanting information about this drug could know what I am prohibited from posting here.
Here is a link to saphris in relation to people taking the drug having death.
Lou
http://www.ehealthme.com/ds/saphris/death
Posted by SLS on February 28, 2012, at 14:21:56
In reply to Lou's reply-agranulocytosis-death, posted by Lou Pilder on February 28, 2012, at 13:51:02
From your link:
Regarding Saphris:
(I added the asterisks for emphasis).
"Agranulocytosis (including fatal cases) has been reported with *other* agents in the class."
The only antipsychotic drug that produces agranulocytosis is clozapine (Clozaril). The entire class of drugs has earned a warning because on this one drug.
Not only is the word "death" used in your subject line an exaggeration of the sequalae of taking Saphris, but your projecting agranulocytosis from clozapine the the rest of the drugs in the class is a generalization that is not born out in fact.
Your posts, as seen here, habitually include:
1. Exaggeration
2. Over-generalizationI have demonstrated this numerous times.
In case you didn't know the difference:* Misinformation: Information that is incorrect.
* Disinformation: Misinformation that is deliberately disseminated in order to influence or confuse or to promote an agenda.
Your statements regarding agranulocytosis and Saprhis are incorrect.
- Scott
Posted by Lou Pilder on February 28, 2012, at 15:26:09
In reply to Re: Lou's reply-agranulocytosis-death » Lou Pilder, posted by SLS on February 28, 2012, at 14:21:56
scott,
This is the aspect that I am attempting to explain, in that Clozaril caused agranulocytosis and then the whole class of those type of drugs is suspect.
Now I have shown a report where one took saphris and got agranulocytosis. I did intend to show the chemical structure of saphris and let people make up their own mind if the drug could cause a blood disease, be it neutropenia or agranulocytosis. The point here is that death is possible from taking saphris and I was going to post the FDA synopsis of the deaths in the trials.
Here is the link to the post here that I posted a link where one got agranulocytosis, and one person getting it does show that it is possible and as time runs, we could see if other reports substantiate that it can happen. The drug is newer on the market so there has not been a great amount of time for reports to be cataloged. I want to post this information here that is factual concerning that there is a case of agranulocytosis from taking saphris and that neutropenia is listed in the PI as a possibility. As to if the one will be more evident going forward, there is still neutropenia listed now.
Here is the link to the post here that has the link to the report of a person with agranulocytosis while taking saphris. If one could get agranulocytosis, that is a warning as I see it for those that are considering taking the drug.
Lou
Here is a link to the post here that has the link to the report
http://www.dr-bob.org/babble/20120221/msgs/1011866.html
Posted by Lou Pilder on February 28, 2012, at 15:43:29
In reply to Lou's reply-agranulocytosis-death-report » SLS, posted by Lou Pilder on February 28, 2012, at 15:26:09
> scott,
> This is the aspect that I am attempting to explain, in that Clozaril caused agranulocytosis and then the whole class of those type of drugs is suspect.
> Now I have shown a report where one took saphris and got agranulocytosis. I did intend to show the chemical structure of saphris and let people make up their own mind if the drug could cause a blood disease, be it neutropenia or agranulocytosis. The point here is that death is possible from taking saphris and I was going to post the FDA synopsis of the deaths in the trials.
> Here is the link to the post here that I posted a link where one got agranulocytosis, and one person getting it does show that it is possible and as time runs, we could see if other reports substantiate that it can happen. The drug is newer on the market so there has not been a great amount of time for reports to be cataloged. I want to post this information here that is factual concerning that there is a case of agranulocytosis from taking saphris and that neutropenia is listed in the PI as a possibility. As to if the one will be more evident going forward, there is still neutropenia listed now.
> Here is the link to the post here that has the link to the report of a person with agranulocytosis while taking saphris. If one could get agranulocytosis, that is a warning as I see it for those that are considering taking the drug.
> Lou
> Here is a link to the post here that has the link to the report
> http://www.dr-bob.org/babble/20120221/msgs/1011866.htmlFriends,
Here is a warning from the FDA that I think if one considering taking the drug could read it, their life could be saved if they knew this information and had the situation arise to them.
The reaction from saphris could cause death.
Lou
http://www.fda.gov/Drugs/DrugSafety/ucm270243
Posted by SLS on February 28, 2012, at 15:59:24
In reply to Lou's reply-agranulocytosis-death-report » SLS, posted by Lou Pilder on February 28, 2012, at 15:26:09
> This is the aspect that I am attempting to explain, in that Clozaril caused agranulocytosis and then the whole class of those type of drugs is suspect.
On what grounds?
> Now I have shown a report where one took saphris and got agranulocytosis.
No, you haven't.
All you showed is that some private website says there was one instance reported to the FDA. No reference information was given to be able to corroborate this assertion. Medline/pubmed does not report a single case. Even if there were a single case, what does that say about the degree of danger possessed by Saphris. You have actually proven that Saphris is quite safe with respect to agranulocytosis.
Okay.
Enough about Saphris and agranulocytosis. If it occurs, you have proven that it is extremely rare.
- Scott
Posted by SLS on February 28, 2012, at 16:06:29
In reply to Lou's reply--death-report-fda, posted by Lou Pilder on February 28, 2012, at 15:43:29
> Here is a warning from the FDA that I think if one considering taking the drug could read it, their life could be saved if they knew this information and had the situation arise to them.
> The reaction from saphris could cause death.> http://www.fda.gov/Drugs/DrugSafety/ucm270243
Penicillin also produces fatal allergic reactions.
A great number of drugs do.
Where is the danger with Saphris? What is the observed rate of allergic reaction to Saphris? Is it higher than from penicillin?
- Scott
Posted by Lou Pilder on February 28, 2012, at 19:51:39
In reply to Saphris and Agranulocytosis - No risk » Lou Pilder, posted by SLS on February 28, 2012, at 15:59:24
> > This is the aspect that I am attempting to explain, in that Clozaril caused agranulocytosis and then the whole class of those type of drugs is suspect.
>
> On what grounds?
>
> > Now I have shown a report where one took saphris and got agranulocytosis.
>
> No, you haven't.
>
> All you showed is that some private website says there was one instance reported to the FDA. No reference information was given to be able to corroborate this assertion. Medline/pubmed does not report a single case. Even if there were a single case, what does that say about the degree of danger possessed by Saphris. You have actually proven that Saphris is quite safe with respect to agranulocytosis.
>
> Okay.
>
> Enough about Saphris and agranulocytosis. If it occurs, you have proven that it is extremely rare.
>
>
> - Scott
>Friends,
The issue here with saphris as to if it can cause agranulocytosis is not what I intended this thread to be about. I intended to show the chemical structure of the drug, where it came from and what it was used for and then the metamorphosis from the start to the ending up as saphris.
Now one important point is that the drug can cause blood diseases that could be fatal. The aspet of the drug causeing the type of blood disorder that Clozaril caused is mentioned as a warning in the FDA booklet for saphris as that drugs of that class could induce the same conditions. The theory is that the same catagory of drugs could cause the same things to cause death.
Now here is a link that states that saphris can cause agranulocytosis. It goes beyound that Clozaril could cause that because it is a drug like clozaril. It is in the review as you scroll down under adverse effects of saphris.
Since the drug is newer, there could be rapid ongoing changes in product liturature.
Now I intend to show the chemical structure of saphris and then one can decide if saphris is a new drug, or a new name for a knock-off of an old drug and then help people make a better decision as to take this drug or not with the information that I could give here so that lives could be saved, life ruining conditions could be avoided , addiction could be avoided, unless the rule of 3 applies.
Lou
here is the link to the review of saphris
http://www.pharmacistivist.com/2010/January_2010.shtml
Posted by SLS on February 28, 2012, at 20:08:40
In reply to Saphris and Agranulocytosis - No risk-really?, posted by Lou Pilder on February 28, 2012, at 19:51:39
> Friends,
> The issue here with saphris as to if it can cause agranulocytosis is not what I intended this thread to be about.Don't tell me that your thread has been hijacked!
> Now here is a link that states that saphris can cause agranulocytosis.
Where is the link?
> here is the link to the review of saphris
> http://www.pharmacistivist.com/2010/January_2010.shtmlPlease try again.
- Scott
Posted by Lou Pilder on February 28, 2012, at 20:31:29
In reply to Lou's reply--death-report-fda, posted by Lou Pilder on February 28, 2012, at 15:43:29
> > scott,
> > This is the aspect that I am attempting to explain, in that Clozaril caused agranulocytosis and then the whole class of those type of drugs is suspect.
> > Now I have shown a report where one took saphris and got agranulocytosis. I did intend to show the chemical structure of saphris and let people make up their own mind if the drug could cause a blood disease, be it neutropenia or agranulocytosis. The point here is that death is possible from taking saphris and I was going to post the FDA synopsis of the deaths in the trials.
> > Here is the link to the post here that I posted a link where one got agranulocytosis, and one person getting it does show that it is possible and as time runs, we could see if other reports substantiate that it can happen. The drug is newer on the market so there has not been a great amount of time for reports to be cataloged. I want to post this information here that is factual concerning that there is a case of agranulocytosis from taking saphris and that neutropenia is listed in the PI as a possibility. As to if the one will be more evident going forward, there is still neutropenia listed now.
> > Here is the link to the post here that has the link to the report of a person with agranulocytosis while taking saphris. If one could get agranulocytosis, that is a warning as I see it for those that are considering taking the drug.
> > Lou
> > Here is a link to the post here that has the link to the report
> > http://www.dr-bob.org/babble/20120221/msgs/1011866.html
>
> Friends,
> Here is a warning from the FDA that I think if one considering taking the drug could read it, their life could be saved if they knew this information and had the situation arise to them.
> The reaction from saphris could cause death.
> Lou
> http://www.fda.gov/Drugs/DrugSafety/ucm270243Friends,
here is an article that I think could be helpful in this discussion.
Lou
To see this:
A. Pull up Google
B. Type in:
[Soulful Sepulcher, saphris]
usually the top one...posted on July 8 2011
Posted by SLS on February 28, 2012, at 20:55:18
In reply to Lou's reply--death-saphris, posted by Lou Pilder on February 28, 2012, at 20:31:29
One thing at a time.
> > Now here is a link that states that saphris can cause agranulocytosis.
> Where is the link?
> > here is the link to the review of saphris
> > http://www.pharmacistivist.com/2010/January_2010.shtml> Please try again.
You promised a link to a review of Saphris that would detail its having caused agranulocytosis. Where is it?
- Scott
Posted by Lou Pilder on February 28, 2012, at 21:58:32
In reply to Lou's reply--death-saphris, posted by Lou Pilder on February 28, 2012, at 20:31:29
> > > scott,
> > > This is the aspect that I am attempting to explain, in that Clozaril caused agranulocytosis and then the whole class of those type of drugs is suspect.
> > > Now I have shown a report where one took saphris and got agranulocytosis. I did intend to show the chemical structure of saphris and let people make up their own mind if the drug could cause a blood disease, be it neutropenia or agranulocytosis. The point here is that death is possible from taking saphris and I was going to post the FDA synopsis of the deaths in the trials.
> > > Here is the link to the post here that I posted a link where one got agranulocytosis, and one person getting it does show that it is possible and as time runs, we could see if other reports substantiate that it can happen. The drug is newer on the market so there has not been a great amount of time for reports to be cataloged. I want to post this information here that is factual concerning that there is a case of agranulocytosis from taking saphris and that neutropenia is listed in the PI as a possibility. As to if the one will be more evident going forward, there is still neutropenia listed now.
> > > Here is the link to the post here that has the link to the report of a person with agranulocytosis while taking saphris. If one could get agranulocytosis, that is a warning as I see it for those that are considering taking the drug.
> > > Lou
> > > Here is a link to the post here that has the link to the report
> > > http://www.dr-bob.org/babble/20120221/msgs/1011866.html
> >
> > Friends,
> > Here is a warning from the FDA that I think if one considering taking the drug could read it, their life could be saved if they knew this information and had the situation arise to them.
> > The reaction from saphris could cause death.
> > Lou
> > http://www.fda.gov/Drugs/DrugSafety/ucm270243
>
> Friends,
> here is an article that I think could be helpful in this discussion.
> Lou
> To see this:
> A. Pull up Google
> B. Type in:
> [Soulful Sepulcher, saphris]
> usually the top one...posted on July 8 2011Friends,
Here is an article that I think could help in this discussion.
Lou
http://www.pdr.net/drugpages/concisemonograph.aspx?concise=3066
Posted by Lou Pilder on February 29, 2012, at 4:26:53
In reply to Saphris and Agranulocytosis - No risk-really?, posted by Lou Pilder on February 28, 2012, at 19:51:39
> > > This is the aspect that I am attempting to explain, in that Clozaril caused agranulocytosis and then the whole class of those type of drugs is suspect.
> >
> > On what grounds?
> >
> > > Now I have shown a report where one took saphris and got agranulocytosis.
> >
> > No, you haven't.
> >
> > All you showed is that some private website says there was one instance reported to the FDA. No reference information was given to be able to corroborate this assertion. Medline/pubmed does not report a single case. Even if there were a single case, what does that say about the degree of danger possessed by Saphris. You have actually proven that Saphris is quite safe with respect to agranulocytosis.
> >
> > Okay.
> >
> > Enough about Saphris and agranulocytosis. If it occurs, you have proven that it is extremely rare.
> >
> >
> > - Scott
> >
>
> Friends,
> The issue here with saphris as to if it can cause agranulocytosis is not what I intended this thread to be about. I intended to show the chemical structure of the drug, where it came from and what it was used for and then the metamorphosis from the start to the ending up as saphris.
> Now one important point is that the drug can cause blood diseases that could be fatal. The aspet of the drug causeing the type of blood disorder that Clozaril caused is mentioned as a warning in the FDA booklet for saphris as that drugs of that class could induce the same conditions. The theory is that the same catagory of drugs could cause the same things to cause death.
> Now here is a link that states that saphris can cause agranulocytosis. It goes beyound that Clozaril could cause that because it is a drug like clozaril. It is in the review as you scroll down under adverse effects of saphris.
> Since the drug is newer, there could be rapid ongoing changes in product liturature.
> Now I intend to show the chemical structure of saphris and then one can decide if saphris is a new drug, or a new name for a knock-off of an old drug and then help people make a better decision as to take this drug or not with the information that I could give here so that lives could be saved, life ruining conditions could be avoided , addiction could be avoided, unless the rule of 3 applies.
> Lou
> here is the link to the review of saphris
> http://www.pharmacistivist.com/2010/January_2010.shtmlcorrection:
http://www.pharmacistactivist.com/2010/January_2010.shtml
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%"
- Scott
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:
>
> 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
Posted by Lou Pilder on February 29, 2012, at 6:54:50
In reply to Lou's reply- Saphris and Agranulocytosis - risk » SLS, posted by Lou Pilder on February 29, 2012, at 6:49:30
> > 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:
> >
> > 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%"
> >
> >
> > - Scott
>
> Scott, 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/agranulocytosiscorrection:
http://www.ehealthme.com/ds/zyprexa/agranulocytosis
Posted by SLS on February 29, 2012, at 7:02:19
In reply to correction-: Lou's reply- Agranulocytosis - risk, posted by Lou Pilder on February 29, 2012, at 6:54:50
I have completed my address of the issue regarding Saphris and agranulocytosis.
- Scott
Posted by Lou Pilder on February 29, 2012, at 7:40:31
In reply to correction-: Lou's reply- Agranulocytosis - risk, posted by Lou Pilder on February 29, 2012, at 6:54:50
> > > 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:
> > >
> > > 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%"
> > >
> > >
> > > - Scott
> >
> > Scott, 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
>
> correction:
> http://www.ehealthme.com/ds/zyprexa/agranulocytosisFriends,
Scott has brought up a good issue here as to {risk} in relation to taking mind-altering drugs of getting agranulocytosis. But there are many more life-ruining conditions or death or addiction that one can get from psychotropic drugs.
What I would like for members here to know is that when you are taking a psychotropic drug, the dice are being rolled as to if you will get a life-ruining condition or death.
Now when one rolls the dice, and let's say the odds in one roll of getting snake-eyes is 1 out of 36, or .028. But now let's say that you want to know the chances of getting snake eyes OR box cars in one roll of the dice. The chances for box cars is also 1 out of 36, but the chances of getting either of the two is the sum the chances, or in this case 2 out of 36 . And let's suppose that you roll the dice 100 times. Now the chances of getting one of them id mutiplied by 100. So in this case, in one roll the chances are 2 out of 26 or .06. But in 100 rolls, the chances are 6.00 which is greater than one.
Now this is because when people take drugs, they take them usuually 2 or 3 times a day. So they roll the dice twice a day, let's say.
so what I am getting at is that they take the drug for years or for life and could roll the dice thousands of times.
Then there is that there are more than one life-ruining conditions to get. Suppose the chances of a blood disease is .03 and TD is .04 and addiction is .9 and sudden death is .01 and NMS is .12. If you add those up you get 1.01 which is greater than one. And if you take the drug each day for years, you multiply that by the number of days. You see, when one picks a card out of a deck of cards enough times, it approaches a certainty that they will pick the Joker.
Lou
Posted by Solstice on February 29, 2012, at 14:24:36
In reply to Lou's response- what are the chances- goakur, posted by Lou Pilder on February 29, 2012, at 7:40:31
Lou, I think the logic you are using here is faulty.Even with respect to side effects, it's a roll of the dice with an accumulation of risk based on how many times you take the medication. Side effects (or death or life-runiation) do not work like that.
Side effects, large or small, as a rule are generally based on your unique body chemistry. For example, I am not allergic to penicillin. A fair number of people are. My 'chance' of having an allergic reaction is not a roll of the dice every time I take it, and my chances of having a reaction do not increase as I increase the number of times I take it. It's simply a matter of am I, or am I not, allergic to penicillin. If I'm not, then the chance of me having a random future allergic reaction is so remote that it's not even worth considering.
Same with side effects from drugs. Admittedly, there are often side effects that are related to dosage.. and some, for example Tardive Diskenesia, where that side effect and the permanence of it seems to be tied to the dosage and length of time it's taken.
But for the most part, if you don't experience a side effect of a certain medication, you will likely never experience the side effect in question unless other factors are changed (additional meds that interact, other health conditions that interact, changes in dosing, etc.). So it really isn't logical (it's a lot of generalizing and exaggeration) to say that each time you take a medication, you are putting yourself at risk for the whole range of possible side effects, and if it starts out as a .01% chance, then as you accumulate quantity of doses, you exponentially increase your risk to the point that you're just about guaranteed to have a life-ruining or death-causing side effect.
It just doesn't work that way.
Solstice
>
> Friends,
> Scott has brought up a good issue here as to {risk} in relation to taking mind-altering drugs of getting agranulocytosis. But there are many more life-ruining conditions or death or addiction that one can get from psychotropic drugs.
> What I would like for members here to know is that when you are taking a psychotropic drug, the dice are being rolled as to if you will get a life-ruining condition or death.
> Now when one rolls the dice, and let's say the odds in one roll of getting snake-eyes is 1 out of 36, or .028. But now let's say that you want to know the chances of getting snake eyes OR box cars in one roll of the dice. The chances for box cars is also 1 out of 36, but the chances of getting either of the two is the sum the chances, or in this case 2 out of 36 . And let's suppose that you roll the dice 100 times. Now the chances of getting one of them id mutiplied by 100. So in this case, in one roll the chances are 2 out of 26 or .06. But in 100 rolls, the chances are 6.00 which is greater than one.
> Now this is because when people take drugs, they take them usuually 2 or 3 times a day. So they roll the dice twice a day, let's say.
> so what I am getting at is that they take the drug for years or for life and could roll the dice thousands of times.
> Then there is that there are more than one life-ruining conditions to get. Suppose the chances of a blood disease is .03 and TD is .04 and addiction is .9 and sudden death is .01 and NMS is .12. If you add those up you get 1.01 which is greater than one. And if you take the drug each day for years, you multiply that by the number of days. You see, when one picks a card out of a deck of cards enough times, it approaches a certainty that they will pick the Joker.
> Lou
Posted by Lou Pilder on February 29, 2012, at 15:34:56
In reply to Re: Solstice's response - Lhawjik » Lou Pilder, posted by Solstice on February 29, 2012, at 14:24:36
>
> Lou, I think the logic you are using here is faulty.
>
> Even with respect to side effects, it's a roll of the dice with an accumulation of risk based on how many times you take the medication. Side effects (or death or life-runiation) do not work like that.
>
> Side effects, large or small, as a rule are generally based on your unique body chemistry. For example, I am not allergic to penicillin. A fair number of people are. My 'chance' of having an allergic reaction is not a roll of the dice every time I take it, and my chances of having a reaction do not increase as I increase the number of times I take it. It's simply a matter of am I, or am I not, allergic to penicillin. If I'm not, then the chance of me having a random future allergic reaction is so remote that it's not even worth considering.
>
> Same with side effects from drugs. Admittedly, there are often side effects that are related to dosage.. and some, for example Tardive Diskenesia, where that side effect and the permanence of it seems to be tied to the dosage and length of time it's taken.
>
> But for the most part, if you don't experience a side effect of a certain medication, you will likely never experience the side effect in question unless other factors are changed (additional meds that interact, other health conditions that interact, changes in dosing, etc.). So it really isn't logical (it's a lot of generalizing and exaggeration) to say that each time you take a medication, you are putting yourself at risk for the whole range of possible side effects, and if it starts out as a .01% chance, then as you accumulate quantity of doses, you exponentially increase your risk to the point that you're just about guaranteed to have a life-ruining or death-causing side effect.
>
> It just doesn't work that way.
>
> Solstice
>
>
> >
> > Friends,
> > Scott has brought up a good issue here as to {risk} in relation to taking mind-altering drugs of getting agranulocytosis. But there are many more life-ruining conditions or death or addiction that one can get from psychotropic drugs.
> > What I would like for members here to know is that when you are taking a psychotropic drug, the dice are being rolled as to if you will get a life-ruining condition or death.
> > Now when one rolls the dice, and let's say the odds in one roll of getting snake-eyes is 1 out of 36, or .028. But now let's say that you want to know the chances of getting snake eyes OR box cars in one roll of the dice. The chances for box cars is also 1 out of 36, but the chances of getting either of the two is the sum the chances, or in this case 2 out of 36 . And let's suppose that you roll the dice 100 times. Now the chances of getting one of them id mutiplied by 100. So in this case, in one roll the chances are 2 out of 26 or .06. But in 100 rolls, the chances are 6.00 which is greater than one.
> > Now this is because when people take drugs, they take them usuually 2 or 3 times a day. So they roll the dice twice a day, let's say.
> > so what I am getting at is that they take the drug for years or for life and could roll the dice thousands of times.
> > Then there is that there are more than one life-ruining conditions to get. Suppose the chances of a blood disease is .03 and TD is .04 and addiction is .9 and sudden death is .01 and NMS is .12. If you add those up you get 1.01 which is greater than one. And if you take the drug each day for years, you multiply that by the number of days. You see, when one picks a card out of a deck of cards enough times, it approaches a certainty that they will pick the Joker.
> > Lou
>
> Solstice,
I am unsure as to what you are wanting too mean in the above. If you could post answers to the following, then I could have the oportunity to respond accordingly.
A.In,[side effects do not work like that]
1. What about TD? (you agreed on this one)
2. And what about NMS?
3. And what about blood disease?
4. And what about sudden death?
5. And what about cardiac arrest?
6. And what about diabetes?
B. In, [allergic to penicilin]
1. If a person gets reaction shock from penicillin, it was predestined that they would get it when they took it?
2. If one did not get it when they took it the first time, then years later took it again, it is a certainty that they will not get the reaction?
C. In,[...unless other factors are changed]
1. Could there be factors unbeknownst to you?
2. If so, what chance of one getting a reaction that did not get the raction the first time? If it is remote, what criteria, if any, do you use to make that claim?
D. In[each time you take it you arfe putting yourself at risk] (isn't logical).
1. Well, some people think that it is logical that the earth is flat. What criteria do you use, if any, to make that statement?
Lou
Posted by Lou Pilder on March 2, 2012, at 7:05:35
In reply to Lou's reply--saphris-more, posted by Lou Pilder on February 28, 2012, at 21:58:32
> > > > scott,
> > > > This is the aspect that I am attempting to explain, in that Clozaril caused agranulocytosis and then the whole class of those type of drugs is suspect.
> > > > Now I have shown a report where one took saphris and got agranulocytosis. I did intend to show the chemical structure of saphris and let people make up their own mind if the drug could cause a blood disease, be it neutropenia or agranulocytosis. The point here is that death is possible from taking saphris and I was going to post the FDA synopsis of the deaths in the trials.
> > > > Here is the link to the post here that I posted a link where one got agranulocytosis, and one person getting it does show that it is possible and as time runs, we could see if other reports substantiate that it can happen. The drug is newer on the market so there has not been a great amount of time for reports to be cataloged. I want to post this information here that is factual concerning that there is a case of agranulocytosis from taking saphris and that neutropenia is listed in the PI as a possibility. As to if the one will be more evident going forward, there is still neutropenia listed now.
> > > > Here is the link to the post here that has the link to the report of a person with agranulocytosis while taking saphris. If one could get agranulocytosis, that is a warning as I see it for those that are considering taking the drug.
> > > > Lou
> > > > Here is a link to the post here that has the link to the report
> > > > http://www.dr-bob.org/babble/20120221/msgs/1011866.html
> > >
> > > Friends,
> > > Here is a warning from the FDA that I think if one considering taking the drug could read it, their life could be saved if they knew this information and had the situation arise to them.
> > > The reaction from saphris could cause death.
> > > Lou
> > > http://www.fda.gov/Drugs/DrugSafety/ucm270243
> >
> > Friends,
> > here is an article that I think could be helpful in this discussion.
> > Lou
> > To see this:
> > A. Pull up Google
> > B. Type in:
> > [Soulful Sepulcher, saphris]
> > usually the top one...posted on July 8 2011
>
> Friends,
> Here is an article that I think could help in this discussion.
> Lou
> http://www.pdr.net/drugpages/concisemonograph.aspx?concise=3066Friends,
I wrote about the deaths in the trials with saphris. Here is a link to an article that summerizes 1000 pages. If you are considering having a prescriber prescribe you this drug, I am requesting that you show the article to them.
Lou
http://shearlingsplowed.blogspot.com/2009/07/over-1000-pages-of-saphris-asenapine.html
This is the end of the thread.
Psycho-Babble Medication | Extras | FAQ
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