![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 7 to 31 of 69. Go back in thread:
Posted by evenintherain on March 12, 2010, at 16:43:33
In reply to My letter to the FDA, posted by detroitpistons on March 12, 2010, at 15:10:48
interesting. i am glad that there are people trying to do something about this. i tend to have too defeatist an attitude when dealing with entities that have the kind of money the pharmaceutical industry has.
withdrawal from Cymbalta was definitely one of the worst experiences of my life. no one believed me about how bad it was, or how long it took (almost 2 months, and i was only on the drug for 4 weeks), but i could find no other explanation. i vomited so much the lining of my stomach degraded, which caused more vomiting (and an expensive trip to the gastroenterologist). i got extremely irritable and angry (i am usually the person no on has ever seen mad), and i even felt uncontrollable urges to cut myself, which i had never done previously or since. though i normally have frequent nightmares, the ones i experienced during this time were extra bad, and i often woke myself or the person next to me up screaming in fear. while awake, i frequently felt like i was falling, and couldn't do anything to make this go away. that continued for 4 weeks after i stopped the taper.
there is no way to get a dose below 20mg (in the US at least). they come in capsales with sprinkles that are statically charged to dissipate if you open the capsules.
my doctor's only suggestion was start taking it on alternative days, which just drew out the symptoms longer.i'll definitely be signing your petition!
Posted by evenintherain on March 12, 2010, at 17:04:17
In reply to My letter to the FDA, posted by detroitpistons on March 12, 2010, at 15:10:48
i am an idiot, and just realized that my aunt is a consumer representative to the FDA's pharmacological drugs advisory committee. i don't even know what that means (it's not a full time job), but i am certainly happy to pass on any info you would like and see if she can get it to the appropriate people.
i think i have babblemail enabled, i have never used it.
Posted by ed_uk2010 on March 12, 2010, at 17:05:58
In reply to Re: My letter to the FDA, posted by evenintherain on March 12, 2010, at 16:43:33
There is some intersting information here.....
They note that opening a capsule and manually counting the pellets is used to aid withdrawal, in the absense of a low strength tab/capsule.
Posted by detroitpistons on March 12, 2010, at 17:26:15
In reply to Venlafaxine Suspension, posted by ed_uk2010 on March 12, 2010, at 16:12:52
Ed,
Hello again from the colonies! The technique you are describing is great, and it's something that would definitely benefit me, but most people would have no clue and probably wouldn't be comfortable doing that. It's just a shame that it has to come to that point. You know what I mean?
Anyways, since we're on this subject, I wonder how well the Prozac method works for Effexor withdrawal. Are you familiar with this? Since Prozac has such a long half life, I guess some people have tried taking it for a few days at the end of tapering to get over that final "hump."
> Given that venlafaxine (Effexor) is possibly the worst offender among the commonly prescribed antidepressants RE withdrawal symptoms, it would be useful if venlafaxine was commercially available as an oral suspension. Unfortunately, it isn't.
>
> Venlafaxine hydrochloride is freely soluble in water. A venlafaxine oral suspension can be prepared to facilitate tapering, if necessary. Crushed venlafaxine tablets (not m/r caps) can be used as the source of venlafaxine. According to an article that I just read, OraPlus can be used as the suspending agent and OraSweet Syrup as the flavouring. The resulting suspension is stable for several days, and should be kept in the fridge.
>
>
Posted by Phillipa on March 12, 2010, at 17:33:10
In reply to Re: Venlafaxine Suspension » ed_uk2010, posted by detroitpistons on March 12, 2010, at 17:26:15
Don't they also often use benydryl? Phillipa
Posted by detroitpistons on March 12, 2010, at 17:34:23
In reply to Re: My letter to the FDA » detroitpistons, posted by evenintherain on March 12, 2010, at 17:04:17
That would be fantastic!! Did you read through their presentation about Cymbalta?? They ripped Lilly a new one. It's awesome. In case you missed it, here it is again:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterial s/Drugs/PsychopharmacologicDrugsA dvisoryCommittee/UCM172866.pdf
For once, I was proud of people in government. Actually, I am usually proud of our scientifically based agencies like the Centers for Disease Control, the U.S. Geological Survey, NASA, etc.
> i am an idiot, and just realized that my aunt is a consumer representative to the FDA's pharmacological drugs advisory committee. i don't even know what that means (it's not a full time job), but i am certainly happy to pass on any info you would like and see if she can get it to the appropriate people.
> i think i have babblemail enabled, i have never used it.
Posted by detroitpistons on March 12, 2010, at 17:36:14
In reply to Re: My letter to the FDA » detroitpistons, posted by evenintherain on March 12, 2010, at 17:04:17
the link was broken
> i am an idiot, and just realized that my aunt is a consumer representative to the FDA's pharmacological drugs advisory committee. i don't even know what that means (it's not a full time job), but i am certainly happy to pass on any info you would like and see if she can get it to the appropriate people.
> i think i have babblemail enabled, i have never used it.
Posted by ed_uk2010 on March 12, 2010, at 17:43:38
In reply to Re: Venlafaxine Suspension » ed_uk2010, posted by detroitpistons on March 12, 2010, at 17:26:15
Hello :)
> Hello again from the colonies! The technique you are describing is great, and it's something that would definitely benefit me, but most people would have no clue and probably wouldn't be comfortable doing that. It's just a shame that it has to come to that point. You know what I mean?
Absolutely, I agree with you. Many people wouldn't be comfortable doing this.
> Anyways, since we're on this subject, I wonder how well the Prozac method works for Effexor withdrawal. Are you familiar with this? Since Prozac has such a long half life, I guess some people have tried taking it for a few days at the end of tapering to get over that final "hump."
I think it's potentially very useful, especially for people who have taken Prozac previously and tolerated it well. Deciding on the initial dose of Prozac could be difficult (trial and error required).
Posted by ed_uk2010 on March 12, 2010, at 17:45:22
In reply to Re: Venlafaxine Suspension » detroitpistons, posted by Phillipa on March 12, 2010, at 17:33:10
> Don't they also often use benydryl? Phillipa
Anecdotally, diphenhydramine seems to relieve some of the symptoms. I imagine it's particularly useful if insomnia is a problem during withdrawal.
Posted by evenintherain on March 12, 2010, at 18:00:36
In reply to Re: My letter to the FDA » evenintherain, posted by detroitpistons on March 12, 2010, at 17:36:14
> the link was broken
>
> http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterial%20s/Drugs/PsychopharmacologicDrugsA%20dvisoryCommittee/UCM172866.pdf
>
>yes, i did look though that. would have probably helped had i seen it while withdrawing! i will send this to my aunt as well. i am pretty sure she has had experience withdrawing from an SNRI herself so will definitely be sympathetic.
Posted by Bob on March 12, 2010, at 21:11:10
In reply to My letter to the FDA, posted by detroitpistons on March 12, 2010, at 15:10:48
> Who knows if anyone will ever read it, but I figured it was worth a shot. I also thought I might as well start petition...
>
> http://www.petitionspot.com/petitions/ADtaperingkits
>
> RE: Psychopharmacologic Drugs Advisory Committee - SSRI and SNRI Discontinuation Syndrome
>
>
> To Whom it May Concern,
>
> I wasnt exactly sure of whom to contact with my comments. I would have liked to have submitted this message to the comment on regulations section of the FDA website, but I dont have a specific docket number to comment on. Hopefully, this email will see the light of day (I understand that general email inboxes can become flooded). Ideally, Id send this email to the Psychopharmacologic Drugs Advisory Committee or perhaps the Drug Safety and Risk Management Advisory, but I couldnt find separate email address.
>
> First off, Id like to express my gratitude to the PDAC for directly and forcefully addressing the subject matter regarding Eli Lilly and its antidepressant Cymbalta in the following presentation from June 9, 2009. Please accept my deepest thanks! Its nice to know that someone is fighting for us.
>
> http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM172866.pdf
>
> I am not a physician nor a public advocate. However, I am a patient and a student, and I fancy myself as having above average knowledge and understanding of some of the topics presented in the aforementioned document. My experiences are not specifically with Cymbalta, but I think most of the subject matter discussed applies to several, if not most other psychotropic medications on the market today (and the manufacturers that make them).
>
> To me, its crazy that it took everyone so long to accept that discontinuation syndrome actually exists. Thank goodness for the legal actions brought about by consumers such as the class action lawsuits against GlaxoSmithKlines Paxil in both the U.S. and Britain.
>
> Speaking from experience, I can say that withdrawal from these drugs can be absolute hell, even with a proper taper. Consider this: The worst symptoms of heroin withdrawal are usually over within 48-72 hours of the last dose and usually cease completely after about a week. Roughly the same can be said for alcohol withdrawal. By contrast, withdrawal from SSRIs, SNRIs, and benzodiazepines can persist for weeks, months and many months/ year(s) in some reported cases. As the FDA and PDAC know, this is not fiction.
>
> Due to the short half life of Effexor XR, one can begin to experience severe withdrawal symptoms within about 12 hours of a missed dose! This has happened to me. The brain zaps, the anxiety, panic attacks, palpitations, disorientation, etc can happen that quickly. Not everyone has this kind of reaction, but plenty of people do. One of the biggest fears Ive had in my entire lifetime was that of running out of Effexor XR (for whatever reason). Ive had nightmares about going on trips and forgetting to pack my Effexor.
>
> I think that everything that Ive said thus far is somewhat well known by now, but perhaps still not taken very seriously by everyone, prescribers included. Clearly, the PDAC does take this very seriously, and again, Im very grateful for that. I wont belabor the point anymore, but there is still educating that needs to be done. Heres the main reason for my email: Consider someone taking Effexor XR, 225 mg daily, who is going to be discontinuing therapy due to remission or whatever reason. The smallest dose size for this drug is 37.5 mg. This person would most likely begin the taper by going from 225 mg to 187.5 mg for about a week, depending on that persons sensitivity. Then they would go down to 150 mg, etc. Finally, after weeks or months, this person will hopefully get down to 37.5 mg..OK, now what? Some people simply cannot make the jump from 37.5 mg to 0, and some doctors just dont know how to deal with this.
>
> Heres really the main point of my email and it pertains mainly to slide 8 of the FDAC: I think drug companies should be required to provide tapering kits to patients, containing several dose sizes, including solutions that can be administered drop by drop during the final phase of tapering. Stories abound of people sitting at home with magnifying glasses, trying to manually divide up the individual beads contained within Effexor XR capsules! That is the absolute truth. People have done this and they will probably continue to do this, and its just not right. In some cases, its also just inconvenient to taper for the simple fact that you have to go to the pharmacy and get two or three different dosage sizes, and pay a lot more money in the process. And again, some doctors just dont treat this seriously enough. In the case of Effexor XR, you cant even get samples of the 37.5 mg capsules anymore because Wyeth has moved on to marketing Pristiq (a patent extender, in my opinion) and so they dont make Effexor XR samples at all in any dose size.
>
> Making and providing these kits should not be that much of a problem, and it would be invaluable to many, many people. Considering their history of allegedly covering up the truth about withdrawal from these drugs, the pharmaceutical companies should be required to assist in helping patients to taper and it should be FREE of charge. To me, this is a no brainer. Can we make this happen?
>
> Thanks,
>Pristiq is set to become an even worse offender in terms of withdrawal than Effexor in my opinion. The lowest available dose is 50mg, and that is in a sustained release form that is not supposed to be broken. How is one expected to get off that after long term therapy? It has basically been designed to be impossible to taper off of.
Despite all the problems people are having getting off some of these drugs, I think that the medical community is STILL quite indifferent about it. I was just at a major university associated psych center last week and had a staff psychiatrist tell me that some people can have a mild withdrawal when coming off venlaflaxine. My heart sank as I realized that even at this point in time, few people outside of those who suffer through it know what these meds can do to a person trying to get off of them.
Posted by detroitpistons on March 12, 2010, at 21:31:20
In reply to Re: My letter to the FDA » detroitpistons, posted by Bob on March 12, 2010, at 21:11:10
Bob, you are absolutely right. Even though people acknowledge the withdrawal now, it's as if they do it begrudgingly! It's as if they still don't really care. How is this possible? How do they not get it? How many more thousands of stories do they need? This infuriates me!
But that's why I really like this Psychopharmacologic Drugs Advisory Committee that's part of the FDA. Did you read that presentation? It's awesome! They don't pull any punches, and get this...They actually care about anecdotal information! They actually believe people's stories! Wow, what a novel idea. Maybe the patients aren't all "crazy" after all. Whoever wrote that report really "gets it." Now we just need to make sure that everybody else gets it....The problem is that these people are scientists, not politicians.
This is all such friggin BS. It would be so simple to make these kits or to at least make a couple more dose sizes. If I could get any traction on this, I would be prepared to fight like a pitbull. This is a crime.
By the way, I think Pristiq is such a crock. It's is the quintessential "patent extender."
> Pristiq is set to become an even worse offender in terms of withdrawal than Effexor in my opinion. The lowest available dose is 50mg, and that is in a sustained release form that is not supposed to be broken. How is one expected to get off that after long term therapy? It has basically been designed to be impossible to taper off of.
>
> Despite all the problems people are having getting off some of these drugs, I think that the medical community is STILL quite indifferent about it. I was just at a major university associated psych center last week and had a staff psychiatrist tell me that some people can have a mild withdrawal when coming off venlaflaxine. My heart sank as I realized that even at this point in time, few people outside of those who suffer through it know what these meds can do to a person trying to get off of them.
>
>
Posted by evenintherain on March 12, 2010, at 22:06:49
In reply to Re: My letter to the FDA » Bob, posted by detroitpistons on March 12, 2010, at 21:31:20
dp, i have written my aunt a long e-mail about my cymbalta withdrawal and included your e-mail to the committee. after looking around on the site i confirmed that she is actually one of the 11 voting members of the committee and is the consumer advocate, so it may be that she is actually the person who should be getting your e-mail in the first place!
what a happy coincidence.i will inform you of her response as soon as i get it.
Posted by detroitpistons on March 12, 2010, at 23:08:09
In reply to Re: My letter to the FDA » detroitpistons, posted by evenintherain on March 12, 2010, at 22:06:49
Amazing! What a coincidence. Thank you so much!
> dp, i have written my aunt a long e-mail about my cymbalta withdrawal and included your e-mail to the committee. after looking around on the site i confirmed that she is actually one of the 11 voting members of the committee and is the consumer advocate, so it may be that she is actually the person who should be getting your e-mail in the first place!
> what a happy coincidence.
>
> i will inform you of her response as soon as i get it.
Posted by ed_uk2010 on March 13, 2010, at 9:20:21
In reply to Re: My letter to the FDA » evenintherain, posted by detroitpistons on March 12, 2010, at 23:08:09
How popular is Pristiq in the US? We don't even have Pristiq here. I guess Wyeth decided not to bother marketing it because they know full well that our doctors will be told not to prescribe it (which is exactly what happened to Cymbalta). Every time a patent-extender comes out, our doctors get told not to prescribe it! This is bad news for the pharmaceutical industry but it does have its advantages.
Posted by evenintherain on March 13, 2010, at 13:41:38
In reply to Re: My letter to the FDA » detroitpistons, posted by ed_uk2010 on March 13, 2010, at 9:20:21
Hi, here is her response.
She is going to give some serious thought on how to bring the SNRI discontinuation issue to the proper people at the FDA. She is also going to find out to what extent they are already looking at this issue.
in the meantime, anyone who has complaints should definitely register them here: http://www.fda.gov/safety/MedWatch/default.htm
MedWatch is the registry for all adverse events.
ALSO:
The doctor who is head of psychopharm for the FDA and steers the committee is Dr. Thomas Laughren. His contact info is below. Definitely have people concerned about this issue contact him. He is, after all, a public servant. And this is his missive.
Laughren, Thomas P
FDA
DHHS/FDA/CDER/OND/ODEI/DPP
SUPERVISORY MEDICAL OFFICER
WO22
4114
Silver Spring MD 20993
301-796-2260
301-796-9841
thomas.laughren@fda.hhs.govAnyway, my aunt is taking this very seriously and did experience discontinuation syndrome herself (with cymbalta) so knows it needs to be addressed. i am glad you got me to contact her!
she added "BTW, I do remember getting [someone's] very thoughtful email on this issue addressed to the committee writ large, so obviously the FDA forwarded it to all of the members of the committee."
Posted by evenintherain on March 13, 2010, at 13:58:20
In reply to Re: My letter to the FDA » evenintherain, posted by detroitpistons on March 12, 2010, at 23:08:09
might i suggest you add the medwatch link to your petition?
http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm
i would spread this link around as much as possible. i'm sure if more people take the time and effort to fill out this form and send it in the FDA will definitely take this issue seriously.
Posted by detroitpistons on March 13, 2010, at 14:02:08
In reply to Re: My letter to the FDA » detroitpistons, posted by ed_uk2010 on March 13, 2010, at 9:20:21
Ed,
You have no idea how messed up things are over here! Well, you probably do, but that's besides the point...Regardless of what people think of the NHS, at least they don't fall for this patent extender crap.
Here in the States, I think that most independent, scientific panels of doctors and researchers have the exact same mentality as the NHS. They will not have the wool pulled over their eyes.
However, now picture the private, for profit psychiatric offices - the actual doctors in the field. They are visited frequently by drug reps, and for some reason, they believe what the drug reps say, or they're somehow in bed with the drug reps. It's a total conflict of interest. Some doctors are just borderline crooked. I used to work as a buyer for industrial raw materials, and I can say that most companies prohibit accepting gifts from suppliers. Such is not the case for doctors. Here's a pretty good article:
http://www.scu.edu/ethics/publications/submitted/morreim/prescribing.html
Bottom line...They stop getting Effexor samples and start getting Pristiq samples. So what do they do? They put people on Pristiq, even if there is no evidence of "clinically significant" advantages. Just browsing around the "internets," I can see that many, many people are being transitioned over to Pristiq. For what? So yes, Pristiq is becoming the dominant form of venlafaxine over here.
At the same time, Osmotica Pharmaceuticals now makes an extended release venlafaxine tablet**. I know they provide samples, so I don't understand the sudden rush to transition to Pristiq. Well, I do. Drug reps have these doctors in their back pockets.
**Get this, due to patent litigation, companies like Osmotica aren't allowed to make a direct equivalent to Effexor XR quite yet. They can't make extended release beads packaged in capsules. Therefore, they have to make extended release venlafaxine in tablet form. Because of this, it is not considered a "true" generic/ substitute. This is all so silly. It borders on circus-like ridiculousness.
> How popular is Pristiq in the US? We don't even have Pristiq here. I guess Wyeth decided not to bother marketing it because they know full well that our doctors will be told not to prescribe it (which is exactly what happened to Cymbalta). Every time a patent-extender comes out, our doctors get told not to prescribe it! This is bad news for the pharmaceutical industry but it does have its advantages.
>
>
Posted by detroitpistons on March 13, 2010, at 14:04:00
In reply to How to contact the FDA if you have drug concerns, posted by evenintherain on March 13, 2010, at 13:41:38
evenintherain,
You are the best! This is so incredibly awesome!
> Hi, here is her response.
>
> She is going to give some serious thought on how to bring the SNRI discontinuation issue to the proper people at the FDA. She is also going to find out to what extent they are already looking at this issue.
>
> in the meantime, anyone who has complaints should definitely register them here: http://www.fda.gov/safety/MedWatch/default.htm
>
> MedWatch is the registry for all adverse events.
>
> ALSO:
>
> The doctor who is head of psychopharm for the FDA and steers the committee is Dr. Thomas Laughren. His contact info is below. Definitely have people concerned about this issue contact him. He is, after all, a public servant. And this is his missive.
>
>
> Laughren, Thomas P
> FDA
> DHHS/FDA/CDER/OND/ODEI/DPP
> SUPERVISORY MEDICAL OFFICER
> WO22
> 4114
> Silver Spring MD 20993
> 301-796-2260
> 301-796-9841
> thomas.laughren@fda.hhs.gov
>
> Anyway, my aunt is taking this very seriously and did experience discontinuation syndrome herself (with cymbalta) so knows it needs to be addressed. i am glad you got me to contact her!
>
> she added "BTW, I do remember getting [someone's] very thoughtful email on this issue addressed to the committee writ large, so obviously the FDA forwarded it to all of the members of the committee."
Posted by ed_uk2010 on March 13, 2010, at 14:23:17
In reply to Re: My letter to the FDA » ed_uk2010, posted by detroitpistons on March 13, 2010, at 14:02:08
Hi DP,
Very interesting post. Personally, I think that samples are a big part of the problem. The most that doctors get from drug reps over here is pens and note pads! I think it's important to bear in mind that there is nothing generous about samples ie. the entire purpose is to get as many people as possible onto a new and usually very expensive product which will certainly not continue to be available for free in the long run.
Wyeth discontinued Effexor tablets in the UK a while ago due to low prescribing (generics are available). They still do the m/r caps but there is now very low demand for these too. Most people have been on the generic for 18 months plus. I guess Wyeth were less successful in protecting their patent here!
> You have no idea how messed up things are over here! Well, you probably do, but that's besides the point...Regardless of what people think of the NHS, at least they don't fall for this patent extender crap.
>
> Here in the States, I think that most independent, scientific panels of doctors and researchers have the exact same mentality as the NHS. They will not have the wool pulled over their eyes.
>
> However, now picture the private, for profit psychiatric offices - the actual doctors in the field. They are visited frequently by drug reps, and for some reason, they believe what the drug reps say, or they're somehow in bed with the drug reps. It's a total conflict of interest. Some doctors are just borderline crooked. I used to work as a buyer for industrial raw materials, and I can say that most companies prohibit accepting gifts from suppliers. Such is not the case for doctors. Here's a pretty good article:
>
> http://www.scu.edu/ethics/publications/submitted/morreim/prescribing.html
>
> Bottom line...They stop getting Effexor samples and start getting Pristiq samples. So what do they do? They put people on Pristiq, even if there is no evidence of "clinically significant" advantages. Just browsing around the "internets," I can see that many, many people are being transitioned over to Pristiq. For what? So yes, Pristiq is becoming the dominant form of venlafaxine over here.
>
> At the same time, Osmotica Pharmaceuticals now makes an extended release venlafaxine tablet**. I know they provide samples, so I don't understand the sudden rush to transition to Pristiq. Well, I do. Drug reps have these doctors in their back pockets.
>
> **Get this, due to patent litigation, companies like Osmotica aren't allowed to make a direct equivalent to Effexor XR quite yet. They can't make extended release beads packaged in capsules. Therefore, they have to make extended release venlafaxine in tablet form. Because of this, it is not considered a "true" generic/ substitute. This is all so silly. It borders on circus-like ridiculousness.
>
> > How popular is Pristiq in the US? We don't even have Pristiq here. I guess Wyeth decided not to bother marketing it because they know full well that our doctors will be told not to prescribe it (which is exactly what happened to Cymbalta). Every time a patent-extender comes out, our doctors get told not to prescribe it! This is bad news for the pharmaceutical industry but it does have its advantages.
> >
> >
>
>
Posted by detroitpistons on March 13, 2010, at 15:10:23
In reply to Re: My letter to the FDA, posted by evenintherain on March 13, 2010, at 13:58:20
You're absolutely right...This form has much, much more credibility than those online petitions. In fact, I don't think I'm going to focus much on that anymore because I don't think online petitions are taken very seriously.
> might i suggest you add the medwatch link to your petition?
>
> http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm
>
> i would spread this link around as much as possible. i'm sure if more people take the time and effort to fill out this form and send it in the FDA will definitely take this issue seriously.
Posted by evenintherain on March 13, 2010, at 15:38:55
In reply to Re: My letter to the FDA » evenintherain, posted by detroitpistons on March 13, 2010, at 15:10:23
i think anything that documents or gets patient complaints in writing is probably helpful. i don't want to be seen as some anti-drug crusader or conspiracy theorist (because i'm neither!) but i don't think your petition implies that at all.
Posted by linkadge on March 14, 2010, at 11:18:07
In reply to Venlafaxine Suspension, posted by ed_uk2010 on March 12, 2010, at 16:12:52
to come off effexor I just opened the 37.5mg caps and counted pellets.
So 1 37.5 was an average of 120 pellets I'd come down by say 20 pellets every few days.
Linkadge
Posted by detroitpistons on March 14, 2010, at 12:51:38
In reply to Re: Venlafaxine Suspension, posted by linkadge on March 14, 2010, at 11:18:07
Yeah. You shouldn't have to do that. It should already be done for you. It's infuriating.
> to come off effexor I just opened the 37.5mg caps and counted pellets.
>
> So 1 37.5 was an average of 120 pellets I'd come down by say 20 pellets every few days.
>
> Linkadge
Posted by detroitpistons on March 14, 2010, at 13:01:18
In reply to Re: My letter to the FDA » detroitpistons, posted by evenintherain on March 13, 2010, at 15:38:55
OK, so I sent Dr. Laughren my original email, and then I also sent him this (the formatting has been lost):
Hello again Dr. Laughren,
As a follow-up to my original message, Id like to give you some further thoughts and (rhetorical) questions regarding this issue. I was sitting at my computer and I just started typing this, with no particular audience in mind.Its sort of an open letter to anyone who will listen. This is just me thinking out loud (err, in print).
Thanks for reading
A comprehensive, systematic and strategic approach needs to be put into place in order to facilitate the process of discontinuation from antidepressant therapy. Have the pharmaceutical companies conducted any meaningful research on discontinuation? If so, have the data been shared with anyone and/or utilized in the field? I suspect not, and I also suspect that complications from discontinuation are underreported. Im an outsider, so Im just speculating here, but I do have my ear to the ground, so to speak. I would think that research is probably necessary in order to collect the sample data necessary for statistical analysis.Because successful discontinuation is highly individualized and seems to be based on a variety of factors, we need to at least have a sense of the scope of the larger statistical picture. Even based solely on anecdotal accounts and information, is there really any doubt that the frequency of discontinuation complications is indeed statistically significant? So why dont we do something? Dont we need basic distribution ranges of data collected for some of the major variables involved in discontinuation? But do we even know which variables need to be studied? Some things that come to mind are patients dosage sizes, length of treatment prior to discontinuation, titration rates and quantities with corresponding responses and outcomes, largest possible dose size that will still facilitate comfortable discontinuation, etc. Obviously, these are just some things from the top of my head, and Im certainly no expert, but my gut feeling tells me that we dont even really know which variables to measure. Until we decide to measure anything at all, I guess its a moot point.
The current shot in the dark approach and the paucity of information available to practitioners results in haphazard discontinuation planning. The less than optimal discontinuation outcomes that are characterized by significant disruptions of patients daily lives and impairment of their daily functioning are not figments of the imagination. This is a clinical reality and it needs to be treated as such, even if its unprofitable. Research is conducted and data are collected on virtually all other aspects of antidepressant therapy. Why then, is discontinuation not studied, and seemingly, not taken very seriously (as a whole)? If it is studied, then where are the data and are they being utilized? How many million Google hits on (fill in antidepressant) withdrawal do we need to see in order to finally begin to take a scientific approach to this issue?
Its time that pharmaceutical companies are held accountable for what happens after consumers start purchasing their products. Sure, theyll make sure that you have what you need to titrate up, but youre on your own after that. Effectively, they have pawned this responsibility off on ill-prepared physicians and patients. At the very least, drug manufacturers should be made to provide more dose sizes for discontinuation. Again, in this regard, they have placed the onus on practitioners and patients to come up with their own ramshackle solutions. Often this means opening capsules to separate extended release beads into smaller quantities, turning everyday Americans into amateur pharmacists. Often, people end up taking Benadryl or Dramamine or benzodiazepines in order to ease withdrawal (why dont we just call it what it really is?).
Is compounding even possible with extended release formulations? Even in cases which compounding is possible (by real pharmacists, of course!), why should the patients have to bear the responsibility and cost to have this done? Would it really be such a burden to these companies to produce some smaller dosing units and/or oral suspensions/ solutions? I have a hard time believing that the act of manufacturing and distributing these products is a significant barrier. Additionally, depending upon the medication, it can be difficult to get the required combinations of dose sizes, especially when samples are not available, as in the case of Effexor XR. Wyeth has discontinued all samples of Effexor XR (venlafaxine HCl) in favor of the new and improved Pristiq/ desvenlafaxine HCl (gee, what a clever chemical name!). Therefore, doctors and patients have to somehow acquire various dose sizes, essentially on their own. Then of course, in the case of Effexor XR, its not necessarily easy to jump from that last 37.5 mg dose to zero. A huge number of people have reported not being able to make that transition. There seems to be no formal approach to dealing with this issue and in my opinion, physicians are ill equipped to deal with discontinuation challenges. They simply cant prescribe incrementally smaller doses for lack of availability. Something needs to be done.
Its no secret that some of the psychotropic pharmaceutical manufacturers have knowingly failed to inform physicians and patients of the possibility and severity of the so called discontinuation syndrome. The lawsuits and settlements have confirmed this reality. Until we begin to take a methodical approach to the process of discontinuation, all that we have is junk science incredibly irresponsible, unethical, and thoroughly embarrassing, junk science.
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Dr. Bob is Robert Hsiung, MD,
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