![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 28 to 52 of 69. Go back in thread:
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.
Posted by SLS on March 14, 2010, at 14:53:36
In reply to Venlafaxine Suspension, posted by ed_uk2010 on March 12, 2010, at 16:12:52
> Crushed venlafaxine tablets (not m/r caps) can be used as the source of venlafaxine.
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.
- Scott
Posted by detroitpistons on March 14, 2010, at 15:10:27
In reply to Re: Venlafaxine Suspension, posted by SLS on March 14, 2010, at 14:53:36
Were you sitting there counting pellets? That's fine for some people, but it doesn't work for every kind of medication, and not everybody is even going to know that it is an option. Besides, if you have poor eyesight or shaky hands, good luck with that. Some of the people on this board like yourself are probably part of, we'll say, the top 1% of patients with a serious depth of knowledge. Not everybody is like that.
My beef is in principle. We shouldn't have to be doing this crap. It's insane. When a company puts out products like some of these medications, that company has a duty to the consumer. Covering up knowledge of withdrawal and misrepresenting that information, to me, is heinous.
What's so hard about making a kit for tapering?
> > Crushed venlafaxine tablets (not m/r caps) can be used as the source of venlafaxine.
>
> 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.
>
>
> - Scott
Posted by evenintherain on March 14, 2010, at 15:43:08
In reply to Re: My letter to the FDA, posted by detroitpistons on March 14, 2010, at 13:01:18
you did a good job of summing up the problems. i hope he responds.
Posted by evenintherain on March 14, 2010, at 15:48:01
In reply to Re: Venlafaxine Suspension, posted by SLS on March 14, 2010, at 14:53:36
i was told by both my pharmacist and my doctor i couldn't do this (with cymbalta, but turns out plenty of people do). i wish they had been able to help me at the time. instead they just said take the lowest dose every other day and then every third day. that was (unsurprisingly) very unhelpful, and just made things worse.
i think drs. need to be more aware of the issue so they can help their patients.
Posted by linkadge on March 14, 2010, at 16:11:55
In reply to Re: Venlafaxine Suspension » SLS, posted by detroitpistons on March 14, 2010, at 15:10:27
Well, there are two possibilities I can think of. One, they don't want you to get off so they don't make smaller doses. Two, they don't make smaller doses because they're only worried about practical sizes for people on the drug.
Linkadge
Posted by linkadge on March 14, 2010, at 16:13:41
In reply to Re: Venlafaxine Suspension » SLS, posted by evenintherain on March 14, 2010, at 15:48:01
off topic, but drug companies are idiots. I am still confused by the recent celebrex comercial. A bunch of old people acting like children then....ask your doctor. Ask my doctor? about what? I have no idea what the drug is for.
Linkadge
Posted by detroitpistons on March 14, 2010, at 16:26:41
In reply to Re: Venlafaxine Suspension, posted by linkadge on March 14, 2010, at 16:13:41
LOL! Exactly. I remember seeing the commercial for Rogaine? I'm pretty sure it was Rogaine. Anyways, I was so confused by that because they didn't say what it was for, at all.
> off topic, but drug companies are idiots. I am still confused by the recent celebrex comercial. A bunch of old people acting like children then....ask your doctor. Ask my doctor? about what? I have no idea what the drug is for.
>
> Linkadge
Posted by detroitpistons on March 14, 2010, at 16:32:51
In reply to Re: Venlafaxine Suspension » SLS, posted by evenintherain on March 14, 2010, at 15:48:01
The easiest drug to come off of for me was Lexapro, but it still wasn't a cakewalk. Lexapro was also more convenient and practical to taper because it's a tablet and you can break it into halves and quarters.
Some people are more sensitive than others, and that's why the medical community should take this more seriously. There are a few people who can just stop, and I envy them. A have a friend who can just quit taking Effexor with no bran zaps, nothing. It's incredible.
> i was told by both my pharmacist and my doctor i couldn't do this (with cymbalta, but turns out plenty of people do). i wish they had been able to help me at the time. instead they just said take the lowest dose every other day and then every third day. that was (unsurprisingly) very unhelpful, and just made things worse.
>
> i think drs. need to be more aware of the issue so they can help their patients.
Posted by detroitpistons on March 14, 2010, at 16:45:16
In reply to Re: Venlafaxine Suspension » SLS, posted by evenintherain on March 14, 2010, at 15:48:01
Did you see slide #8 of the presentation? I love it. It points to the line in the Cymbalta literature that says "You should not break, open, or chew the capsule" and responds with, "Opening the capsules is required to taper!"
> i was told by both my pharmacist and my doctor i couldn't do this (with cymbalta, but turns out plenty of people do). i wish they had been able to help me at the time. instead they just said take the lowest dose every other day and then every third day. that was (unsurprisingly) very unhelpful, and just made things worse.
>
> i think drs. need to be more aware of the issue so they can help their patients.
Posted by ed_uk2010 on March 14, 2010, at 16:48:03
In reply to Re: Venlafaxine Suspension » SLS, posted by evenintherain on March 14, 2010, at 15:48:01
>I was told by both my pharmacist and my doctor i couldn't do this (with cymbalta, but turns out plenty of people do).
Yeah, you can do it. It's the individual pellets which are enteric coated, not the capsule shell. It's important to swallow the pellets whole though ie. no sucking or chewing. The docs and pharmacists are just repeating the manufacturer's information. The manufacturer discourages opening the capsules because some people might suck or chew the pellets and damage the coating. Duloxetine (Cymbalta) is degraded by stomach acid, hence the need for the protective coating.
Posted by ed_uk2010 on March 14, 2010, at 17:01:10
In reply to Re: Venlafaxine Suspension » evenintherain, posted by detroitpistons on March 14, 2010, at 16:45:16
>"You should not break, open, or chew the capsule"
This is typical of the unhelpful information found on product information sheets. Provided that the pellets are placed on the tongue and swallowed straight away, it isn't likely to be a problem. If someone was finding the pellets difficult to swallow quickly enough to ensure that they weren't damaged, it might be helpful to get a pack of empty gelatin capsules and put the pellets in a capsule. Empty capsules can be bought quite cheaply online.
Alternate day dosing is totally inappropriate for short-acting drugs such as Effexor and Cymbalta. It leads to peaks and troughs in blood levels, which only makes matters worse. I find it annoying that some doctors are recommending this harmful practice. Very long-acting drugs such as fluoxetine (Prozac), on the other hand, can often be tapered by reducing the frequency of administration.
Posted by ed_uk2010 on March 14, 2010, at 17:06:42
In reply to Re: Venlafaxine Suspension, posted by SLS on March 14, 2010, at 14:53:36
>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.
Posted by Bob on March 14, 2010, at 17:18:21
In reply to Re: Venlafaxine Suspension » evenintherain, posted by detroitpistons on March 14, 2010, at 16:32:51
> The easiest drug to come off of for me was Lexapro, but it still wasn't a cakewalk. Lexapro was also more convenient and practical to taper because it's a tablet and you can break it into halves and quarters.
>
> Some people are more sensitive than others, and that's why the medical community should take this more seriously. There are a few people who can just stop, and I envy them. A have a friend who can just quit taking Effexor with no bran zaps, nothing. It's incredible.That is incredible. We may never know the true reality of what withdrawals are like statistically in severity, duration, and frequency per patient, and the drug companies are extremely motivated to not look into these issues, or not call any attention to what is already know. Doctor's can't be expected to know what it's like if there was never a palpable effort to educate them, much less the victims.
I've often been told when I try to describe my withdrawal problems about how there are other people don't have problems. Because severe withdrawals are a minority percentage they are basically ignored. I'm not sure this will change in our lifetimes.
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
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