![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
[email protected]Shown: posts 45 to 69 of 69. Go back in thread:
Posted by Bob on March 14, 2010, at 17:27:27
In reply to Effexor Taper-Tabs » SLS, posted by ed_uk2010 on March 14, 2010, at 17:06:42
>
> I don't think we'll ever see 'Effexor Taper-Tabs 5mg' on the market, but they would be useful. Has a nice ring to it too.
>
>I wholeheartedly agree. You will never see tapering tabs or kits. Even though it is desperately needed for some meds, I'd imagine drug companies see it as the kiss of death for sales. Better to let people suffer enormously while struggling to figure it out for themselves.
Posted by SLS on March 15, 2010, at 6:39:56
In reply to Effexor Taper-Tabs » SLS, posted by ed_uk2010 on March 14, 2010, at 17:06:42
> >I found that the pellets in the Effexor XR preparation worked well to taper with. I simply sprinkled the pellets on my tongue and washed them down with water. No big deal.
>
> Yeah, you're right. It was just a suggestion really. A suspension would be useful for patients who find it difficult to count pellets eg. due to arthritis.
>
> I don't think we'll ever see 'Effexor Taper-Tabs 5mg' on the market, but they would be useful. Has a nice ring to it too.
I never needed to count pellets. I pretty much just eyeballed the amount to be ingested. I did not follow a rigid dosing schedule. I simply waited until withdrawal symptoms appeared, and dosed immediately afterward. I have used this method to discontinue various drugs, including benzodiazepines. I have a hard time thinking that I am unique in this regard.I thought about the desirability of the pharmaceutical companies to produce taper packs that follow a fixed dosing schedule. I imagine they would be beneficial for a great many people. Unfortunately, individuals accommodate to dosage reductions at different rates. It would probably be better to have available pills composed of very small amounts of drug that can be used to taper - taper doses. One would simply count pills and taper the number taken.
- Scott
Posted by Bob on March 15, 2010, at 13:49:19
In reply to Re: Effexor Taper-Tabs » ed_uk2010, posted by SLS on March 15, 2010, at 6:39:56
>
> I thought about the desirability of the pharmaceutical companies to produce taper packs that follow a fixed dosing schedule. I imagine they would be beneficial for a great many people. Unfortunately, individuals accommodate to dosage reductions at different rates. It would probably be better to have available pills composed of very small amounts of drug that can be used to taper - taper doses. One would simply count pills and taper the number taken.
>
>
> - Scott
Yes, I think that what is needed for all of these medicines is a something like a 'pediatric dose', i.e., a dose of a few mgs or so that pills can be added or subtracted in small increments according to the patients needs. There would be need for a "kit" per se.However, pharmaceutical companies would absolutely have to educate all doctors and patients about how to realistically taper off of one of these drugs using a small dosage. No more blowing the whole issue off like they've been doing for two decades.
Posted by ed_uk2010 on March 15, 2010, at 14:37:34
In reply to Re: Effexor Taper-Tabs » ed_uk2010, posted by SLS on March 15, 2010, at 6:39:56
> It would probably be better to have available pills composed of very small amounts of drug that can be used to taper - taper doses. One would simply count pills and taper the number taken.
I agree Scott. Some people would find little tablets easier to handle than pellets inside capsules. All we need is, say, a pack of 100 x 5mg tabs of Effexor. Part of the problem at the moment is that some doctors and pharmacists are either not aware that capsules can be opened, or specifically tell patients not to do so.
Posted by detroitpistons on March 15, 2010, at 16:04:45
In reply to My letter to the FDA, posted by detroitpistons on March 12, 2010, at 15:10:48
Response from the general FDA/CDER mailbox:
Dear detroitpistons (not really),
Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research. I am sorry to learn of the problems you have tapering off Effexor.
As with any new drug the company would have to submit an application for a new drug approval for a tapering kit. The application would have to be supported by data from clinical trials. The FDA does not have the authority to require a firm to produce a product.
If you have not already done so, I would urge you to submit a MedWatch report.
You may submit your voluntary report via the following methods.
You can find a link to the Internet voluntary reporting form by going to the MedWatch homepage (http://www.fda.gov/Safety/MedWatch/default.htm), click on "Reporting Serious Problems to FDA", then "Reporting by Health Professionals" or "Reporting by Consumers".
In the Resources For You box on the left you can choose to:
1. Complete the voluntary form 3500 online.
2. Download a copy of the form and either fax it to us at 1-800-FDA-0178 or mail it back using the postage-paid addressed form.
If you are reporting a product problem with a generic drug product, please supply the NDC (National Drug Code) number. The NDC number on a product identifies the labeler/vendor, the product, and the trade package size. You can ask your pharmacist for this number. If you cannot obtain the NDC number, as an alternative, please provide the imprint code printed on your tablet/capsule. Product problems are quality, performance or safety concerns such as:
* Suspected counterfeit product
* Suspected contamination
* Questionable stability
* Defective components
* Poor packaging or labeling
* Therapeutic failures (product didn't work)You will be personally contacted by an FDA staff member only if we need additional information. With the volume of reports on all issues, the Center does not have the resources to provide direct feedback to each reporter, or to confirm whether a report was received for a particular individual/incident or the status or outcome of a report.
The internet MedWatch on-line reports are acknowledged immediately via the internet and the reporter is able to print out a final copy of their report. This accounts for 60-70% of direct reports.
Mail and faxed reports with complete information, including a valid mailing address receive the MedWatch acknowledgement letter below if they provide a drug, an event, a patient and a reporter. This may take 2-3 weeks in processing.
Voluntary reports are essential for ensuring the continued safety of FDA-regulated products. Reports submitted to MedWatch are added to a post marketing safety database and reviewed by the FDA's post marketing safety staff. One or two well-documented case reports may provide an early signal of unexpected safety issues and lead to additional evaluation. This may result in FDA regulatory actions that improve the safety of the products used in patient care each day. We carefully evaluate and analyze all reports that were available to us and make recommendations for possible actions if the science based risk evaluation warrants the actions.
If the report contributed to the action, the labeling change and/or public advisory will reflect the action.We rely on our website to offer new safety information on drug as a means to convey the results of investigations from MedWatch reports. Information about emerging safety signals is posted on the CDER Internet page at
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111085.htm, and MedWatch posts information on safety-related labeling changes at http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm.
Best Regards,
BDDivision of Drug Information
Center for Drug Evaluation and Research
Food and Drug AdministrationFor up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at FDA_Drug_Info
This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
Posted by Phillipa on March 15, 2010, at 19:25:58
In reply to Re: My letter to the FDA, posted by detroitpistons on March 15, 2010, at 16:04:45
Nice that you got a reply but reminds me of doc in NYC that reported just in his practice 120 cases of spontaneous femur fractures from oral biophosphinates and due to the fact that the replaced bone was cruppling no plates could be attached just rods placed in. He also got a nice letter. And I just got a notification in nursing newsletter that FDA had deemed them safe for now but further studies were being done. Phillipa
Posted by Phillipa on March 15, 2010, at 19:44:48
In reply to Re: My letter to the FDA » detroitpistons, posted by Phillipa on March 15, 2010, at 19:25:58
Speaking of the FDA look what just came in my mailbox seems like they are paying attention to above. Phillipa
From Medscape Medical News
Long-Term Bisphosphonate Use Linked to Abnormal Bone Formation
Fran Lowry
March 12, 2010 (New Orleans, Louisiana) An unusual type of bone fracture has been reported in women who have taken bisphosphonates for osteopenia and osteoporosis for more than 4 years, according to 2 studies reported here at the American Association of Orthopaedic Surgeons 2010 Annual Meeting.
"Bisphosphonates are wonderful drugs. They've cut the vertebral fracture rate by 70% and the hip fracture rate by 50%. People die from hip fractures. There has been great enthusiasm for these drugs, and clearly the rate of hip fractures is decreasing," said Joseph Lane, MD, chief of the Metabolic Bone Service at the Hospital for Special Surgery and professor of orthopedic surgery at Weill Cornell Medical College in New York CIty.
But concern is mounting that long-term use might adversely affect bone quality, he added.
There is significant morbidity and mortality associated with osteoporotic fractures. Vertebral fractures can result in chronic disabling pain, and 1 in 5 patients who have a hip fracture die within 1 year, researchers told meeting attendees.
Bisphosphonates have been shown to prevent the rapid loss of bone that occurs during the first years of menopause and to reduce the incidence of fracture in postmenopausal women.
However, there have been reports of "peculiar" fractures that is, low-energy femur fractures that are typically transverse or slightly oblique, diaphyseal, or subtrochanteric, with thickened cortices and a unicortical beak in patients who have been on long-term bisphosphonate treatment. The first report was published in 2005 in a "semi-obscure" journal, Dr. Lane told Medscape Orthopaedics.
In a small prospective study, Dr. Lane and his colleagues obtained bone biopsies from the lateral femurs of 21 postmenopausal women with femoral fractures. Twelve of the women had been on bisphosphonate therapy for an average duration of 8.5 years, and 9 had no history of bisphosphonate use.
They found that the heterogeneities of the mineral/matrix ratio were significantly reduced in the bisphosphonate group by 28%, and the crystallinity of the bone was significantly reduced by 33% (P < .05).
"The biopsies showed that the bone was very, very old," Dr. Lane said. "This suggests to us that suppression of bone turnover, which is what bisphosphonates do [over the] long term, results in a loss of heterogeneity of the tissue properties, and this may be a contributing factor to the risk of atypical fractures that we are starting to see."
In a second unrelated study, Melvin P. Rosenwasser, MD, Robert E. Carroll Professor of Hand Surgery at Columbia University in New York City, and colleagues evaluated the bone structure of 112 postmenopausal women with primary osteoporosis, 62 of whom had been taking bisphosphonates for at least 4 years, and 50 control subjects who were taking only calcium and vitamin D supplements.
They found that bisphosphonate use improved structural integrity early in the course of treatment, but that these gains were diminished as treatment extended beyond 4 years.
"It seems as if there is a plateau of benefit at 4 or 5 years and, after that, the benefit is negated. In the early treatment period, patients using bisphosphonates experienced improvements in all parameters, including decreased buckling ratio and increased cross-sectional area," he said in an interview with Medscape Orthopaedics. "But after 4 years of use, these trends reversed."
Women who are being treated with bisphosphonates should take a drug holiday if they have been on them for 5 years, both investigators told Medscape Orthopaedics.
"These drugs are excellent," Dr. Rosenwasser said. "But women should take some time off of them. Exercise caution. Don't throw them away, but don't stay on them for long periods."
Dr. Lane added that "bisphosphonates are wonderful for preventing fractures. At 5 years, however, go back and talk to your doctor and ask if you should continue the drug or take a rest period. This is what I would tell my patients. Nobody in my field would ever treat a patient past 5 years. We're never going to do that again because our information suggests that you need a rest period."
It would also be a good idea for women who have been on bisphosphonates for more than 5 years to have a test to measure their bone turnover, Dr. Lane said.
However, this can be problematic for a number of reasons. Many physicians do not know how to interpret tests for bone turnover. The tests are controversial, and most insurance companies will not pay for them, "so it's a real problem right now," he said.
The American Society of Bone and Mineral Research has struck a task force on these atypical fractures and is in the process of developing a consensus statement to warn the public, Dr. Lane added. "The goal is to have this available by the fall of 2010, at least to give some guidelines to the public."
Approached for independent comment about these 2 studies, Thomas Moore, MD, director of trauma at Emory University in Atlanta, Georgia, agreed that there is increasing evidence that the long-term use of bisphosphonates can cause spontaneous transverse fractures, particularly in the femur in women.
"The question is whether or not the [US Food and Drug Administration] should put out some warnings about this particular clinical entity. I myself have seen this occur. Women are taking these bisphosphonates for osteoporosis, and in fact they do decrease hip fractures, but these new types of fractures represent a catastrophic complication that really needs to be looked at statistically, and appropriate warnings [need to] be put out."
Dr. Lane, Dr. Rosenwasser, and Dr. Moore have disclosed no relevant financial relationships.
American Association of Orthopaedic Surgeons (AAOS) 2010 Annual Meeting: Abstract 241, presented March 10, 2010; Abstract 339, presented March 11, 2010
Posted by detroitpistons on March 15, 2010, at 20:18:55
In reply to Re: My letter to the FDA » detroitpistons, posted by Phillipa on March 15, 2010, at 19:25:58
Phillipa,
I know I'm wasting my time with this. It's next to impossible to mobilize enough people to actually raise a stink over this. Not enough people seem to care anyways, or they're just too ill and preoccupied. You need big canons to pierce the armor of the bureaucracy. I think a lot of people over at the FDA are probably just puppets of big pharma. At least I tried though. At least I asked questions.
Keep in mind that the response that I posted was just from the general mailbox. I guess I really didn't expect much out of that, but the response really friggin pissed me off. "We can't make them make products." Bulls**t!! You can make them make small dose sizes when it's in the interest of public safety! I didn't include one part of my response because I felt stupid about saying it, but I said that I would think about making phone calls to 20/20, Dateline, etc and I also said that I know a lot of young attorneys eager to make names for themselves. Does anybody reading this deny that this is a drug safety issue and that it should fall squarely on the shoulders of the FDA? I bet there have been suicides over withdrawal, but I just can't prove it.
Anyways, I was just playing around with that general mailbox. The ace up my sleeve is the other email address that I sent messages too. I didn't say anything impolite to him. He's Dr. Thomas Laughren, a psychiatrist and director for psychiatric products. I wonder if he'll actually respond. I wonder what he will say. I'll tell you what...If he doesn't respond to me, I won't stop trying to contact him. I have his phone number, fax and email address.
I think I have a pretty solid argument. There's absolutely NO science behind this. Is there? Shouldn't there be? How can they answer that? What can they possibly say to me? Dr. Laughren is a scientist and I asked him scientific questions. All I want is some answers. I want to know why there is no research or attention to this. Ultimately, all I want is for them to acknowledge the severity and frequency of withdrawal and just provide us with some smaller doses. That's it!!
Deep breaths. LOL :)
> Nice that you got a reply but reminds me of doc in NYC that reported just in his practice 120 cases of spontaneous femur fractures from oral biophosphinates and due to the fact that the replaced bone was cruppling no plates could be attached just rods placed in. He also got a nice letter. And I just got a notification in nursing newsletter that FDA had deemed them safe for now but further studies were being done. Phillipa
Posted by detroitpistons on March 15, 2010, at 20:38:20
In reply to Re: I'll Be Darned Just Received, posted by Phillipa on March 15, 2010, at 19:44:48
The American Society of Bone and Mineral Research? OK, if there is such a thing as "The American Society of Bone and Mineral Research," surely there must be some other organization that would take my side. That just gave me a good idea. Maybe I'll contact the American Psychiatric Association. On their website it says, "Member Driven. Science Based. Patient Focused." Hmmm, science based and patient focused. With that motto, if they don't listen to me, nobody will.....And probably nobody will :)
> Speaking of the FDA look what just came in my mailbox seems like they are paying attention to above. Phillipa
>
> From Medscape Medical News
> Long-Term Bisphosphonate Use Linked to Abnormal Bone Formation
> Fran Lowry
>
>
> March 12, 2010 (New Orleans, Louisiana) An unusual type of bone fracture has been reported in women who have taken bisphosphonates for osteopenia and osteoporosis for more than 4 years, according to 2 studies reported here at the American Association of Orthopaedic Surgeons 2010 Annual Meeting.
>
> "Bisphosphonates are wonderful drugs. They've cut the vertebral fracture rate by 70% and the hip fracture rate by 50%. People die from hip fractures. There has been great enthusiasm for these drugs, and clearly the rate of hip fractures is decreasing," said Joseph Lane, MD, chief of the Metabolic Bone Service at the Hospital for Special Surgery and professor of orthopedic surgery at Weill Cornell Medical College in New York CIty.
>
> But concern is mounting that long-term use might adversely affect bone quality, he added.
>
> There is significant morbidity and mortality associated with osteoporotic fractures. Vertebral fractures can result in chronic disabling pain, and 1 in 5 patients who have a hip fracture die within 1 year, researchers told meeting attendees.
>
> Bisphosphonates have been shown to prevent the rapid loss of bone that occurs during the first years of menopause and to reduce the incidence of fracture in postmenopausal women.
>
> However, there have been reports of "peculiar" fractures that is, low-energy femur fractures that are typically transverse or slightly oblique, diaphyseal, or subtrochanteric, with thickened cortices and a unicortical beak in patients who have been on long-term bisphosphonate treatment. The first report was published in 2005 in a "semi-obscure" journal, Dr. Lane told Medscape Orthopaedics.
>
> In a small prospective study, Dr. Lane and his colleagues obtained bone biopsies from the lateral femurs of 21 postmenopausal women with femoral fractures. Twelve of the women had been on bisphosphonate therapy for an average duration of 8.5 years, and 9 had no history of bisphosphonate use.
>
> They found that the heterogeneities of the mineral/matrix ratio were significantly reduced in the bisphosphonate group by 28%, and the crystallinity of the bone was significantly reduced by 33% (P < .05).
>
> "The biopsies showed that the bone was very, very old," Dr. Lane said. "This suggests to us that suppression of bone turnover, which is what bisphosphonates do [over the] long term, results in a loss of heterogeneity of the tissue properties, and this may be a contributing factor to the risk of atypical fractures that we are starting to see."
>
> In a second unrelated study, Melvin P. Rosenwasser, MD, Robert E. Carroll Professor of Hand Surgery at Columbia University in New York City, and colleagues evaluated the bone structure of 112 postmenopausal women with primary osteoporosis, 62 of whom had been taking bisphosphonates for at least 4 years, and 50 control subjects who were taking only calcium and vitamin D supplements.
>
> They found that bisphosphonate use improved structural integrity early in the course of treatment, but that these gains were diminished as treatment extended beyond 4 years.
>
> "It seems as if there is a plateau of benefit at 4 or 5 years and, after that, the benefit is negated. In the early treatment period, patients using bisphosphonates experienced improvements in all parameters, including decreased buckling ratio and increased cross-sectional area," he said in an interview with Medscape Orthopaedics. "But after 4 years of use, these trends reversed."
>
> Women who are being treated with bisphosphonates should take a drug holiday if they have been on them for 5 years, both investigators told Medscape Orthopaedics.
>
> "These drugs are excellent," Dr. Rosenwasser said. "But women should take some time off of them. Exercise caution. Don't throw them away, but don't stay on them for long periods."
>
> Dr. Lane added that "bisphosphonates are wonderful for preventing fractures. At 5 years, however, go back and talk to your doctor and ask if you should continue the drug or take a rest period. This is what I would tell my patients. Nobody in my field would ever treat a patient past 5 years. We're never going to do that again because our information suggests that you need a rest period."
>
> It would also be a good idea for women who have been on bisphosphonates for more than 5 years to have a test to measure their bone turnover, Dr. Lane said.
>
> However, this can be problematic for a number of reasons. Many physicians do not know how to interpret tests for bone turnover. The tests are controversial, and most insurance companies will not pay for them, "so it's a real problem right now," he said.
>
> The American Society of Bone and Mineral Research has struck a task force on these atypical fractures and is in the process of developing a consensus statement to warn the public, Dr. Lane added. "The goal is to have this available by the fall of 2010, at least to give some guidelines to the public."
>
> Approached for independent comment about these 2 studies, Thomas Moore, MD, director of trauma at Emory University in Atlanta, Georgia, agreed that there is increasing evidence that the long-term use of bisphosphonates can cause spontaneous transverse fractures, particularly in the femur in women.
>
> "The question is whether or not the [US Food and Drug Administration] should put out some warnings about this particular clinical entity. I myself have seen this occur. Women are taking these bisphosphonates for osteoporosis, and in fact they do decrease hip fractures, but these new types of fractures represent a catastrophic complication that really needs to be looked at statistically, and appropriate warnings [need to] be put out."
>
> Dr. Lane, Dr. Rosenwasser, and Dr. Moore have disclosed no relevant financial relationships.
>
> American Association of Orthopaedic Surgeons (AAOS) 2010 Annual Meeting: Abstract 241, presented March 10, 2010; Abstract 339, presented March 11, 2010
>
Posted by Phillipa on March 15, 2010, at 21:03:01
In reply to Re: I'll Be Darned Just Received, posted by detroitpistons on March 15, 2010, at 20:38:20
Good idea try a google search. What about the NIMH? Phillipa no I know there is withdrawal my next door neighbor a teacher had horrible withdrawl from guess what? Effexor. Two weeks for her I think. Phillipa
Posted by floatingbridge on March 16, 2010, at 0:21:40
In reply to Re: My letter to the FDA » detroitpistons, posted by Bob on March 12, 2010, at 21:11:10
Bob, yes, I agree about pristiq, which I take. I'm ill w/in 6-8 hours of a missed dose.
Many many docs do not take the more severe 'discontinuation syndrome' reactions seriously. Then again, I have a friend who responds to mono-therapy of lexapro (maybe not as notorious as effexor) and starts and stops w/ minor discomfort. Am I envious?
Posted by floatingbridge on March 16, 2010, at 0:25:04
In reply to My letter to the FDA, posted by detroitpistons on March 12, 2010, at 15:10:48
Thank you for this!
> 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,
>
Posted by floatingbridge on March 16, 2010, at 0:58:39
In reply to Re: I'll Be Darned Just Received, posted by Phillipa on March 15, 2010, at 19:44:48
Wow Phillipa, you've been so right all along.... This is really something.
> Speaking of the FDA look what just came in my mailbox seems like they are paying attention to above. Phillipa
>
> From Medscape Medical News
> Long-Term Bisphosphonate Use Linked to Abnormal Bone Formation
> Fran Lowry
>
>
> March 12, 2010 (New Orleans, Louisiana) An unusual type of bone fracture has been reported in women who have taken bisphosphonates for osteopenia and osteoporosis for more than 4 years, according to 2 studies reported here at the American Association of Orthopaedic Surgeons 2010 Annual Meeting.
>
> "Bisphosphonates are wonderful drugs. They've cut the vertebral fracture rate by 70% and the hip fracture rate by 50%. People die from hip fractures. There has been great enthusiasm for these drugs, and clearly the rate of hip fractures is decreasing," said Joseph Lane, MD, chief of the Metabolic Bone Service at the Hospital for Special Surgery and professor of orthopedic surgery at Weill Cornell Medical College in New York CIty.
>
> But concern is mounting that long-term use might adversely affect bone quality, he added.
>
> There is significant morbidity and mortality associated with osteoporotic fractures. Vertebral fractures can result in chronic disabling pain, and 1 in 5 patients who have a hip fracture die within 1 year, researchers told meeting attendees.
>
> Bisphosphonates have been shown to prevent the rapid loss of bone that occurs during the first years of menopause and to reduce the incidence of fracture in postmenopausal women.
>
> However, there have been reports of "peculiar" fractures that is, low-energy femur fractures that are typically transverse or slightly oblique, diaphyseal, or subtrochanteric, with thickened cortices and a unicortical beak in patients who have been on long-term bisphosphonate treatment. The first report was published in 2005 in a "semi-obscure" journal, Dr. Lane told Medscape Orthopaedics.
>
> In a small prospective study, Dr. Lane and his colleagues obtained bone biopsies from the lateral femurs of 21 postmenopausal women with femoral fractures. Twelve of the women had been on bisphosphonate therapy for an average duration of 8.5 years, and 9 had no history of bisphosphonate use.
>
> They found that the heterogeneities of the mineral/matrix ratio were significantly reduced in the bisphosphonate group by 28%, and the crystallinity of the bone was significantly reduced by 33% (P < .05).
>
> "The biopsies showed that the bone was very, very old," Dr. Lane said. "This suggests to us that suppression of bone turnover, which is what bisphosphonates do [over the] long term, results in a loss of heterogeneity of the tissue properties, and this may be a contributing factor to the risk of atypical fractures that we are starting to see."
>
> In a second unrelated study, Melvin P. Rosenwasser, MD, Robert E. Carroll Professor of Hand Surgery at Columbia University in New York City, and colleagues evaluated the bone structure of 112 postmenopausal women with primary osteoporosis, 62 of whom had been taking bisphosphonates for at least 4 years, and 50 control subjects who were taking only calcium and vitamin D supplements.
>
> They found that bisphosphonate use improved structural integrity early in the course of treatment, but that these gains were diminished as treatment extended beyond 4 years.
>
> "It seems as if there is a plateau of benefit at 4 or 5 years and, after that, the benefit is negated. In the early treatment period, patients using bisphosphonates experienced improvements in all parameters, including decreased buckling ratio and increased cross-sectional area," he said in an interview with Medscape Orthopaedics. "But after 4 years of use, these trends reversed."
>
> Women who are being treated with bisphosphonates should take a drug holiday if they have been on them for 5 years, both investigators told Medscape Orthopaedics.
>
> "These drugs are excellent," Dr. Rosenwasser said. "But women should take some time off of them. Exercise caution. Don't throw them away, but don't stay on them for long periods."
>
> Dr. Lane added that "bisphosphonates are wonderful for preventing fractures. At 5 years, however, go back and talk to your doctor and ask if you should continue the drug or take a rest period. This is what I would tell my patients. Nobody in my field would ever treat a patient past 5 years. We're never going to do that again because our information suggests that you need a rest period."
>
> It would also be a good idea for women who have been on bisphosphonates for more than 5 years to have a test to measure their bone turnover, Dr. Lane said.
>
> However, this can be problematic for a number of reasons. Many physicians do not know how to interpret tests for bone turnover. The tests are controversial, and most insurance companies will not pay for them, "so it's a real problem right now," he said.
>
> The American Society of Bone and Mineral Research has struck a task force on these atypical fractures and is in the process of developing a consensus statement to warn the public, Dr. Lane added. "The goal is to have this available by the fall of 2010, at least to give some guidelines to the public."
>
> Approached for independent comment about these 2 studies, Thomas Moore, MD, director of trauma at Emory University in Atlanta, Georgia, agreed that there is increasing evidence that the long-term use of bisphosphonates can cause spontaneous transverse fractures, particularly in the femur in women.
>
> "The question is whether or not the [US Food and Drug Administration] should put out some warnings about this particular clinical entity. I myself have seen this occur. Women are taking these bisphosphonates for osteoporosis, and in fact they do decrease hip fractures, but these new types of fractures represent a catastrophic complication that really needs to be looked at statistically, and appropriate warnings [need to] be put out."
>
> Dr. Lane, Dr. Rosenwasser, and Dr. Moore have disclosed no relevant financial relationships.
>
> American Association of Orthopaedic Surgeons (AAOS) 2010 Annual Meeting: Abstract 241, presented March 10, 2010; Abstract 339, presented March 11, 2010
>
Posted by SLS on March 17, 2010, at 23:49:45
In reply to Re: My letter to the FDA » Bob, posted by floatingbridge on March 16, 2010, at 0:21:40
The SSRI discontinuation syndrome is no longer completely ignored. Studies are being designed to explore the phenomenon more closely. Recently, a study of SSRI discontinuation syndrome using paroxetine and fMRI demonstrated a set of functional differences in brain activity during symptomatic episodes. The syndrome is now recognized by science, although it may not be by all clinical practitioners. Drug companies know about this stuff. I imagine they would rather not call any attention to it. Hopefully, letters to the FDA will not fall upon deaf ears. I just hope that the populace does not use the existence of this discontinuation syndrome to further fuel the backlash against antidepressants in general. We still need these drugs.
- Scott
Posted by SLS on March 18, 2010, at 0:25:09
In reply to Re: My letter to the FDA, posted by SLS on March 17, 2010, at 23:49:45
> The SSRI discontinuation syndrome is no longer completely ignored. Studies are being designed to explore the phenomenon more closely. Recently, a study of SSRI discontinuation syndrome using paroxetine and fMRI demonstrated a set of functional differences in brain activity during symptomatic episodes. The syndrome is now recognized by science, although it may not be by all clinical practitioners. Drug companies know about this stuff. I imagine they would rather not call any attention to it. Hopefully, letters to the FDA will not fall upon deaf ears. I just hope that the populace does not use the existence of this discontinuation syndrome to further fuel the backlash against antidepressants in general. We still need these drugs.
Here are two studies indicating significant changes in brain function associated with the emergence of SRI drug discontinuation symptoms. It is interesting that a DS rating scale has been devised.These studies might prove useful in demonstrating a physiological basis for DS to addressees of petition letters.
- Scott--------------------------------------------
Biol Psychiatry. 2003 Jan 1;53(1):100-5.
Cerebral blood volume and clinical changes on the third day of placebo substitution for SSRI treatment.Henry ME, Kaufman MJ, Hennen J, Michelson D, Schmidt ME, Stoddard E, Vukovic AJ, Barreira PJ, Cohen BM, Renshaw PF.
Brain Imaging Center, McLean Hospital and Department of Psychiatry, Harvard Medical School, Belmont, Massachusetts 02478, USA.
BACKGROUND: Interruptions in SSRI treatment have been associated with adverse effects that can resemble depressive illness. We hypothesized that brain regions implicated in depression, with extensive serotonergic innervation, would exhibit changes in activity associated with emergence of symptoms following drug discontinuation. METHODS: Subjects meeting DSM-IV criteria for remitted major depression on 20 mg/day of either fluoxetine or paroxetine were recruited into this 6-week study. During weeks 2 and 6, subjects underwent a 3-day period in which either active drug or placebo was substituted for their medication under double-blind conditions. Cerebral blood volume (CBV) maps were obtained via dynamic susceptibility magnetic resonance imaging at the end of each double-blind period. RESULTS: In the paroxetine group, change in CBV in left medial superior frontal region and left caudate nucleus correlated significantly with change in Discontinuation Emergent Symptom Scale and Hamilton Depression Rating Scale (HDRS; R2 = 0.66, p =.0007; R2 = 0.51, p =.006; and R2 = 0.43, p =.015; R2 = 0.32, p =.043, respectively). CONCLUSIONS: These data demonstrate that changes in regional CBV of left prefrontal cortex and left caudate nucleus correlate with the emergence of discontinuation symptoms and increased HDRS after interruption of paroxetine treatment.
Biol Psychiatry. 2003 Sep 1;54(5):534-9.
Selective serotonin reuptake inhibitor discontinuation syndrome is associated with a rostral anterior cingulate choline metabolite decrease: a proton magnetic resonance spectroscopic imaging study.Kaufman MJ, Henry ME, Frederick B, Hennen J, Villafuerte RA, Stoddard EP, Schmidt ME, Cohen BM, Renshaw PF.
Brain Imaging Center, McLean Hospital, Harvard Medical School, Belmont, Massachusetts 02478, USA.
The selective serotonin reuptake inhibitor (SSRI) discontinuation syndrome (DS) is an important potential complication of treatment for major depression. We hypothesized that SSRI treatment discontinuation, resulting in change in clinical state, would be associated with reduced rostral anterior cingulate choline (Cho) metabolite ratios. Individuals with a DSM-III-R diagnosis of unipolar major depression who had been stabilized on paroxetine (n = 13) or fluoxetine (n = 13) were study subjects. They were monitored for change in clinical state (mood ratings, discontinuation symptoms) and underwent proton magnetic resonance spectroscopic imaging of the rostral anterior cingulate 3 days after medication substitution with active SSRI and placebo.Placebo-day Cho/Cre (choline/total creatine) metabolite ratios were decreased in four paroxetine and two fluoxetine subjects meeting DS criteria, as compared with asymptomatic subjects (Mann-Whitney z = -2.31, p =.021). Discontinuation syndrome is associated with a rostral anterior cingulate Cho/Cre metabolite ratio decrease that may reflect dynamics of rostral anterior cingulate function.
PMID: 12946882 [PubMed - indexed for MEDLINE]
Posted by Bob on March 18, 2010, at 0:57:15
In reply to Re: My letter to the FDA, posted by SLS on March 17, 2010, at 23:49:45
> The SSRI discontinuation syndrome is no longer completely ignored. Studies are being designed to explore the phenomenon more closely. Recently, a study of SSRI discontinuation syndrome using paroxetine and fMRI demonstrated a set of functional differences in brain activity during symptomatic episodes. The syndrome is now recognized by science, although it may not be by all clinical practitioners. Drug companies know about this stuff. I imagine they would rather not call any attention to it. Hopefully, letters to the FDA will not fall upon deaf ears. I just hope that the populace does not use the existence of this discontinuation syndrome to further fuel the backlash against antidepressants in general. We still need these drugs.
>
>
> - Scott
>
>Anyone who has gone through one of these withdrawals knows something is terribly wrong. A scientific study for verification is a great first step, but the extreme motivations of drug companies to downplay this and the seeming ignorance of many clinical practitioners won't be changing anytime soon. The phenomenon needs to be studied intensely so that maybe in the future drugs can be designed that aren't almost impossible for some people to get off of. Unfortunately, I cannot imagine why a drug company would want to do this.
A backlash against antidepressants would indeed be unfortunate in some respects, but might provide an impetus for drugs that don't create syndromes that are sometimes worse than the original problem. The truth absolutely needs to be faced. There are certain drugs I can never ever go back and try again because I almost lost it trying to get off of them. No one had any advice when I was going through that years ago (especially not the medical community) and that will continue to be the case unless this becomes an up front issue. At least nowadays an enterprising person can dig up the advice of others on internet forums and the like for a little help with discontinuation problems. Regrettably, not everyone is internet savvy or has the fortitude during the sickness of a withdrawal to help themselves. This is, in my opinion, very much the responsibility of the practitioners and drug producers to inform patients in the event of discontinuation problems of how best to deal with it. Right now this type of help is sorely lacking if it exists at all for any given situation.
It's deplorable, really.
Posted by detroitpistons on March 18, 2010, at 1:03:09
In reply to Re: My letter to the FDA, posted by SLS on March 18, 2010, at 0:25:09
This is encouraging. I know that there are researchers out there who take this issue seriously, but whether this research will be applied in the field is yet to be seen. Right now, all we have is each other......
> > The SSRI discontinuation syndrome is no longer completely ignored. Studies are being designed to explore the phenomenon more closely. Recently, a study of SSRI discontinuation syndrome using paroxetine and fMRI demonstrated a set of functional differences in brain activity during symptomatic episodes. The syndrome is now recognized by science, although it may not be by all clinical practitioners. Drug companies know about this stuff. I imagine they would rather not call any attention to it. Hopefully, letters to the FDA will not fall upon deaf ears. I just hope that the populace does not use the existence of this discontinuation syndrome to further fuel the backlash against antidepressants in general. We still need these drugs.
>
>
> Here are two studies indicating significant changes in brain function associated with the emergence of SRI drug discontinuation symptoms. It is interesting that a DS rating scale has been devised.
>
> These studies might prove useful in demonstrating a physiological basis for DS to addressees of petition letters.
>
>
> - Scott
>
> --------------------------------------------
>
> Biol Psychiatry. 2003 Jan 1;53(1):100-5.
> Cerebral blood volume and clinical changes on the third day of placebo substitution for SSRI treatment.
>
> Henry ME, Kaufman MJ, Hennen J, Michelson D, Schmidt ME, Stoddard E, Vukovic AJ, Barreira PJ, Cohen BM, Renshaw PF.
>
> Brain Imaging Center, McLean Hospital and Department of Psychiatry, Harvard Medical School, Belmont, Massachusetts 02478, USA.
>
> BACKGROUND: Interruptions in SSRI treatment have been associated with adverse effects that can resemble depressive illness. We hypothesized that brain regions implicated in depression, with extensive serotonergic innervation, would exhibit changes in activity associated with emergence of symptoms following drug discontinuation. METHODS: Subjects meeting DSM-IV criteria for remitted major depression on 20 mg/day of either fluoxetine or paroxetine were recruited into this 6-week study. During weeks 2 and 6, subjects underwent a 3-day period in which either active drug or placebo was substituted for their medication under double-blind conditions. Cerebral blood volume (CBV) maps were obtained via dynamic susceptibility magnetic resonance imaging at the end of each double-blind period. RESULTS: In the paroxetine group, change in CBV in left medial superior frontal region and left caudate nucleus correlated significantly with change in Discontinuation Emergent Symptom Scale and Hamilton Depression Rating Scale (HDRS; R2 = 0.66, p =.0007; R2 = 0.51, p =.006; and R2 = 0.43, p =.015; R2 = 0.32, p =.043, respectively). CONCLUSIONS: These data demonstrate that changes in regional CBV of left prefrontal cortex and left caudate nucleus correlate with the emergence of discontinuation symptoms and increased HDRS after interruption of paroxetine treatment.
>
>
>
>
>
>
> Biol Psychiatry. 2003 Sep 1;54(5):534-9.
> Selective serotonin reuptake inhibitor discontinuation syndrome is associated with a rostral anterior cingulate choline metabolite decrease: a proton magnetic resonance spectroscopic imaging study.
>
> Kaufman MJ, Henry ME, Frederick B, Hennen J, Villafuerte RA, Stoddard EP, Schmidt ME, Cohen BM, Renshaw PF.
>
> Brain Imaging Center, McLean Hospital, Harvard Medical School, Belmont, Massachusetts 02478, USA.
>
> The selective serotonin reuptake inhibitor (SSRI) discontinuation syndrome (DS) is an important potential complication of treatment for major depression. We hypothesized that SSRI treatment discontinuation, resulting in change in clinical state, would be associated with reduced rostral anterior cingulate choline (Cho) metabolite ratios. Individuals with a DSM-III-R diagnosis of unipolar major depression who had been stabilized on paroxetine (n = 13) or fluoxetine (n = 13) were study subjects. They were monitored for change in clinical state (mood ratings, discontinuation symptoms) and underwent proton magnetic resonance spectroscopic imaging of the rostral anterior cingulate 3 days after medication substitution with active SSRI and placebo.Placebo-day Cho/Cre (choline/total creatine) metabolite ratios were decreased in four paroxetine and two fluoxetine subjects meeting DS criteria, as compared with asymptomatic subjects (Mann-Whitney z = -2.31, p =.021). Discontinuation syndrome is associated with a rostral anterior cingulate Cho/Cre metabolite ratio decrease that may reflect dynamics of rostral anterior cingulate function.
>
> PMID: 12946882 [PubMed - indexed for MEDLINE]
Posted by detroitpistons on March 18, 2010, at 1:27:53
In reply to Re: My letter to the FDA, posted by SLS on March 18, 2010, at 0:25:09
Scott,
Just wanted to mention...Thanks a lot for finding this and sharing it with us.
> > The SSRI discontinuation syndrome is no longer completely ignored. Studies are being designed to explore the phenomenon more closely. Recently, a study of SSRI discontinuation syndrome using paroxetine and fMRI demonstrated a set of functional differences in brain activity during symptomatic episodes. The syndrome is now recognized by science, although it may not be by all clinical practitioners. Drug companies know about this stuff. I imagine they would rather not call any attention to it. Hopefully, letters to the FDA will not fall upon deaf ears. I just hope that the populace does not use the existence of this discontinuation syndrome to further fuel the backlash against antidepressants in general. We still need these drugs.
>
>
> Here are two studies indicating significant changes in brain function associated with the emergence of SRI drug discontinuation symptoms. It is interesting that a DS rating scale has been devised.
>
> These studies might prove useful in demonstrating a physiological basis for DS to addressees of petition letters.
>
>
> - Scott
>
> --------------------------------------------
>
> Biol Psychiatry. 2003 Jan 1;53(1):100-5.
> Cerebral blood volume and clinical changes on the third day of placebo substitution for SSRI treatment.
>
> Henry ME, Kaufman MJ, Hennen J, Michelson D, Schmidt ME, Stoddard E, Vukovic AJ, Barreira PJ, Cohen BM, Renshaw PF.
>
> Brain Imaging Center, McLean Hospital and Department of Psychiatry, Harvard Medical School, Belmont, Massachusetts 02478, USA.
>
> BACKGROUND: Interruptions in SSRI treatment have been associated with adverse effects that can resemble depressive illness. We hypothesized that brain regions implicated in depression, with extensive serotonergic innervation, would exhibit changes in activity associated with emergence of symptoms following drug discontinuation. METHODS: Subjects meeting DSM-IV criteria for remitted major depression on 20 mg/day of either fluoxetine or paroxetine were recruited into this 6-week study. During weeks 2 and 6, subjects underwent a 3-day period in which either active drug or placebo was substituted for their medication under double-blind conditions. Cerebral blood volume (CBV) maps were obtained via dynamic susceptibility magnetic resonance imaging at the end of each double-blind period. RESULTS: In the paroxetine group, change in CBV in left medial superior frontal region and left caudate nucleus correlated significantly with change in Discontinuation Emergent Symptom Scale and Hamilton Depression Rating Scale (HDRS; R2 = 0.66, p =.0007; R2 = 0.51, p =.006; and R2 = 0.43, p =.015; R2 = 0.32, p =.043, respectively). CONCLUSIONS: These data demonstrate that changes in regional CBV of left prefrontal cortex and left caudate nucleus correlate with the emergence of discontinuation symptoms and increased HDRS after interruption of paroxetine treatment.
>
>
>
>
>
>
> Biol Psychiatry. 2003 Sep 1;54(5):534-9.
> Selective serotonin reuptake inhibitor discontinuation syndrome is associated with a rostral anterior cingulate choline metabolite decrease: a proton magnetic resonance spectroscopic imaging study.
>
> Kaufman MJ, Henry ME, Frederick B, Hennen J, Villafuerte RA, Stoddard EP, Schmidt ME, Cohen BM, Renshaw PF.
>
> Brain Imaging Center, McLean Hospital, Harvard Medical School, Belmont, Massachusetts 02478, USA.
>
> The selective serotonin reuptake inhibitor (SSRI) discontinuation syndrome (DS) is an important potential complication of treatment for major depression. We hypothesized that SSRI treatment discontinuation, resulting in change in clinical state, would be associated with reduced rostral anterior cingulate choline (Cho) metabolite ratios. Individuals with a DSM-III-R diagnosis of unipolar major depression who had been stabilized on paroxetine (n = 13) or fluoxetine (n = 13) were study subjects. They were monitored for change in clinical state (mood ratings, discontinuation symptoms) and underwent proton magnetic resonance spectroscopic imaging of the rostral anterior cingulate 3 days after medication substitution with active SSRI and placebo.Placebo-day Cho/Cre (choline/total creatine) metabolite ratios were decreased in four paroxetine and two fluoxetine subjects meeting DS criteria, as compared with asymptomatic subjects (Mann-Whitney z = -2.31, p =.021). Discontinuation syndrome is associated with a rostral anterior cingulate Cho/Cre metabolite ratio decrease that may reflect dynamics of rostral anterior cingulate function.
>
> PMID: 12946882 [PubMed - indexed for MEDLINE]
Posted by detroitpistons on March 18, 2010, at 15:21:20
In reply to Re: My letter to the FDA, posted by SLS on March 18, 2010, at 0:25:09
Scott and Bob,
The "Cerebral blood volume and clinical changes on the third day of placebo substitution for SSRI treatment." is totally fascinating. Wow! I overlooked that yesterday. So all along (since at least 2003), we apparently had pretty convincing evidence that there are actual biological/ physiological changes related to discontinuation. I wonder what kind of impact this study had on the medical/ psychiatric community, if any.
I agree that we need these drugs. I'm not anti-pharmaceuticals. I'm not totally against pharmaceutical companies, but there's a reason why they have developed a bad reputation and why there is a general, popular mistrust of them and/or skepticism about their intentions. Whether that's warranted or not is another issue.
If the FDA completely writes me off or thinks I'm a pain in the butt or some kind of "ranting whack job," then they are guilty of faulty reasoning and they are continuing to avoid the issue. I am asking them very, very specific questions and I'm citing very, very specific information. I am asking them for a fairly specific solution or set of solutions. Therefore, there's not much ambiguity in what I'm saying. If they discard my questions, or if my inquiries don't even spark a little interest in somebody's brain, then it's because they have no answers. All I want is some acknowledgment of the issue.
It took a long time just to get pharmaceutical companies and physicians to admit to the existence of "discontinuation syndrome"!! They told us, "it's in your head." Yeah, it is "in our heads" if you look at the brain scans! That's why I like that study about cerebral blood flow so much. It was placebo controlled. Nobody can rationally say that it's "in our heads" any longer, yet I think some people still don't get it. It took class action lawsuits. I'm not really familiar with the class action Paxil case, but that sort of opened some peoples eyes, but not nearly enough. I believe the main outcomes were money settlements and a labeling change. A labeling change! That really doesn't help much. So really, the issue continued to ignored, by and large.
Today we know that this really exists, but there doesn't seem to be any protocol for dealing with it. There's some research, but is anything actually being done with it? I mean, we have evidence of changes in blood flow in the brain! What more do we really need?!! We have developed protocols for safe alcohol detoxification and safe detox methods for illegal drugs but nobody "owns" alcohol or illegal drugs. So to put it in perspective, we've paid a lot of attention and put a lot of effort and research into detox of illegal drugs (and rightfully so), but we have nothing for legal drugs? What kind of excrement is that? Doesn't this fall into the purview of the FDA? Perhaps the FDA could mandate that approval of certain drugs be contingent upon the completion of specific studies providing discontinuation data, protocols, and tools for discontinuation. Actually, I don't care who does it, as long as somebody does. I just want a plan, plain and simple. In order to come up with a plan, you need statistical means, distributions, correlation coefficients, etc.
Lastly, we need tools to implement plans. My suggestions to the FDA are very specific. I'm asking for smaller dose sizes. What's so hard about that? I guess that would just be too much of a hassle and extra work for everybody, so why not just ignore it? Somebody would have to call their buddies at the pharma companies, and then things would be all awkward, so....let's try to sidestep the issue. OK, that's not completely fair of me to say, but I do believe that there are people within the government and FDA who are perhaps not completely objective due to their relationships with certain other individuals. That's just human nature, but I think it may affect the way things happen. A lot of this is just politics.
At the very least, can we at least try to do some trials where we use Prozac at the very end of discontinuation? Something? Anything?
Right now in argument and philosophy, I feel like I OWN the FDA on this issue. Maybe I don't. Maybe they would turn my argument upside down and make me look like a complete fool. That's possible, but first they have to actually respond to me. But you know what? I'm a nobody, and they don't talk to nobodies. After all, they are doctors MDs and PhDs and I'm just a mental patient, no matter how many FACTS or logical ideas that I bring up. They are public servants, and in this regard, I don't think they're serving the public very well!
Bam! That felt good to get out.
> > The SSRI discontinuation syndrome is no longer completely ignored. Studies are being designed to explore the phenomenon more closely. Recently, a study of SSRI discontinuation syndrome using paroxetine and fMRI demonstrated a set of functional differences in brain activity during symptomatic episodes. The syndrome is now recognized by science, although it may not be by all clinical practitioners. Drug companies know about this stuff. I imagine they would rather not call any attention to it. Hopefully, letters to the FDA will not fall upon deaf ears. I just hope that the populace does not use the existence of this discontinuation syndrome to further fuel the backlash against antidepressants in general. We still need these drugs.
>
>
> Here are two studies indicating significant changes in brain function associated with the emergence of SRI drug discontinuation symptoms. It is interesting that a DS rating scale has been devised.
>
> These studies might prove useful in demonstrating a physiological basis for DS to addressees of petition letters.
>
>
> - Scott
>
> --------------------------------------------
>
> Biol Psychiatry. 2003 Jan 1;53(1):100-5.
> Cerebral blood volume and clinical changes on the third day of placebo substitution for SSRI treatment.
>
> Henry ME, Kaufman MJ, Hennen J, Michelson D, Schmidt ME, Stoddard E, Vukovic AJ, Barreira PJ, Cohen BM, Renshaw PF.
>
> Brain Imaging Center, McLean Hospital and Department of Psychiatry, Harvard Medical School, Belmont, Massachusetts 02478, USA.
>
> BACKGROUND: Interruptions in SSRI treatment have been associated with adverse effects that can resemble depressive illness. We hypothesized that brain regions implicated in depression, with extensive serotonergic innervation, would exhibit changes in activity associated with emergence of symptoms following drug discontinuation. METHODS: Subjects meeting DSM-IV criteria for remitted major depression on 20 mg/day of either fluoxetine or paroxetine were recruited into this 6-week study. During weeks 2 and 6, subjects underwent a 3-day period in which either active drug or placebo was substituted for their medication under double-blind conditions. Cerebral blood volume (CBV) maps were obtained via dynamic susceptibility magnetic resonance imaging at the end of each double-blind period. RESULTS: In the paroxetine group, change in CBV in left medial superior frontal region and left caudate nucleus correlated significantly with change in Discontinuation Emergent Symptom Scale and Hamilton Depression Rating Scale (HDRS; R2 = 0.66, p =.0007; R2 = 0.51, p =.006; and R2 = 0.43, p =.015; R2 = 0.32, p =.043, respectively). CONCLUSIONS: These data demonstrate that changes in regional CBV of left prefrontal cortex and left caudate nucleus correlate with the emergence of discontinuation symptoms and increased HDRS after interruption of paroxetine treatment.
>
>
>
>
>
>
> Biol Psychiatry. 2003 Sep 1;54(5):534-9.
> Selective serotonin reuptake inhibitor discontinuation syndrome is associated with a rostral anterior cingulate choline metabolite decrease: a proton magnetic resonance spectroscopic imaging study.
>
> Kaufman MJ, Henry ME, Frederick B, Hennen J, Villafuerte RA, Stoddard EP, Schmidt ME, Cohen BM, Renshaw PF.
>
> Brain Imaging Center, McLean Hospital, Harvard Medical School, Belmont, Massachusetts 02478, USA.
>
> The selective serotonin reuptake inhibitor (SSRI) discontinuation syndrome (DS) is an important potential complication of treatment for major depression. We hypothesized that SSRI treatment discontinuation, resulting in change in clinical state, would be associated with reduced rostral anterior cingulate choline (Cho) metabolite ratios. Individuals with a DSM-III-R diagnosis of unipolar major depression who had been stabilized on paroxetine (n = 13) or fluoxetine (n = 13) were study subjects. They were monitored for change in clinical state (mood ratings, discontinuation symptoms) and underwent proton magnetic resonance spectroscopic imaging of the rostral anterior cingulate 3 days after medication substitution with active SSRI and placebo.Placebo-day Cho/Cre (choline/total creatine) metabolite ratios were decreased in four paroxetine and two fluoxetine subjects meeting DS criteria, as compared with asymptomatic subjects (Mann-Whitney z = -2.31, p =.021). Discontinuation syndrome is associated with a rostral anterior cingulate Cho/Cre metabolite ratio decrease that may reflect dynamics of rostral anterior cingulate function.
>
> PMID: 12946882 [PubMed - indexed for MEDLINE]
Posted by evenintherain on April 7, 2010, at 20:47:54
In reply to Re: My letter to the FDA » SLS, posted by detroitpistons on March 18, 2010, at 15:21:20
DP, have you heard back from anyone at the FDA yet?
Posted by detroitpistons on April 8, 2010, at 14:43:51
In reply to Re: My letter to the FDA » detroitpistons, posted by evenintherain on April 7, 2010, at 20:47:54
Not a single word...I don't expect to be getting anything either. Perhaps if I filed a formal complaint, I might get a form letter response. I don't have a specific complaint though. Even if they wanted to respond to me, they wouldn't have any good answers for me. They would have to just admit that I'm right and that nothing will be done.
> DP, have you heard back from anyone at the FDA yet?
Posted by evenintherain on April 10, 2010, at 14:43:12
In reply to Re: My letter to the FDA » evenintherain, posted by detroitpistons on April 8, 2010, at 14:43:51
did you file an incident report with medwatch?
Posted by detroitpistons on April 10, 2010, at 15:37:47
In reply to Re: My letter to the FDA, posted by evenintherain on April 10, 2010, at 14:43:12
> did you file an incident report with medwatch?
No, but I might try it at some point in the future. I just don't have a specific incident to report. My inquiry was very general.
Posted by evenintherain on April 11, 2010, at 12:42:17
In reply to Re: My letter to the FDA » evenintherain, posted by detroitpistons on April 10, 2010, at 15:37:47
i know, but we can report our withdrawal symptoms, even though we may not have ended up in the hospital because of them. at least it will be on record.
Posted by detroitpistons on April 11, 2010, at 13:25:17
In reply to Re: My letter to the FDA, posted by evenintherain on April 11, 2010, at 12:42:17
> i know, but we can report our withdrawal symptoms, even though we may not have ended up in the hospital because of them. at least it will be on record.
You're absolutely right. I have had bad experiences in the past, so I'll list both Paxil and Effexor.
This is the end of the thread.
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