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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 16 of 16. This is the beginning of the thread.
Posted by blueberry on May 14, 2006, at 18:33:25
TWO ARTICLES SHOWING PROBLEMS BETWEEN GENERIC AND BRAND. THE SECOND ARTICLE ON CELEXA IS INTERESTING.
Borgheini, G. (2003) 'The bioequivalence and therapeutic efficacy of generic versus brand-name psychoactive drugs', Clinical Therapeutics 25(6): 1578-92. [available online]
This article suggests that present standards for determining bioequivalence between branded and generic medications may be inadequate; from the article's abstract, "Specifically, 1 study found that plasma levels of phenytoin were 31% lower after a switch from a brand-name to a generic product. Several controlled studies of carbamazepine showed a recurrence of convulsions after the shift to a generic formulation. After a sudden recurrence of seizures when generic valproic acid was substituted for the brand-name product, an investigation by the US Food and Drug Administration found a difference in bioavailability between the 2 formulations." The article concludes that "The essential-similarity requirement should be extended to include more rigorous analyses of tolerability and efficacy in actual patients as well as in healthy subjects".Switch From Celexa to Generic Citalopram Caused Anxiety Symptoms to Return: Presented at ADAA
By Fran Lowry
MIAMI, F.L. -- March 29, 2006 -- Patients with a variety of anxiety disorders who were unknowingly switched from Celexa to generic citalopram experienced a resumption of their symptoms or new adverse events within a few days to 8 weeks after the change in medication, researchers reported here at the 26th Annual Conference of the Anxiety Disorders Association of America (ADAA).
The finding from this case-series of 20 patients attending an anxiety clinic should alert clinicians to the fact that generic and brand name drugs may not always have the same efficacy, reported Michael Van Ameringen, MD, FRCPC, associate professor of psychiatry, McMaster University, Hamilton, Ontario, Canada.
Generic medications are cheaper than brand name ones, and can reduce health care costs. However, manufacturers of generic drugs are not required to test these agents in large clinical trials of safety and efficacy, as do those of brand name drugs. While generics do need to have pharmacological equivalence, this may not translate into clinical equivalence, Dr. Van Ameringen said. This is especially true for psychotropic drugs, the investigators noted in their paper.
The 20 patients in the case series were examined after complaining that their symptoms had inexplicably worsened since their last clinic appointment. Some patients also reported an increase in physical adverse effects, such as gastrointestinal problems and headaches.
In these patients, the most common primary diagnosis was obsessive-compulsive disorder (n=11), followed by panic disorder with agoraphobia (n=5), social phobia (n=3), and posttraumatic stress disorder (n=1).
All patients had been well controlled on Celexa, and their symptoms had been stable for a mean of 114.7 ± 109.39 weeks (range 6 – 472 weeks) prior to the switch to generic citalopram.
The investigators obtained patients' consent to contact their pharmacies to determine whether and when generic citalopram was dispensed. "In Canada, pharmacies are not required to inform patients of a change to generic, and most private drug plans mandate the use of generics when available," Dr. Van Ameringen explained.
Examination of the pharmacy records revealed that the mean dose of Celexa at the time of the switch to generic was 45.2 ± 20.6 mg and that half of the patients were taking other medications when they were switched.
Adverse symptoms began to reappear after as few as 4 days of switching. However, once patients were switched back to Celexa, the mean time for response was 3.8 ± 2.6 weeks (range 0.7 – 12 weeks).
"Clinicians should be aware of the potential risks of loss of treatment effect or symptom re-emergence posed by a switch to a generic agent," Dr. Van Ameringen noted. "Prospective, randomized, double blind, controlled investigations would likely provide useful information on this issue."
[Presentation title: Symptom Relapse Following Switch From Celexa to Generic Citalopram: A Clinical Case Series in an Anxiety Disorders Sample. Abstract 408]
Posted by bassman on May 14, 2006, at 19:43:36
In reply to Generic vs Brand...evidence emerging..., posted by blueberry on May 14, 2006, at 18:33:25
Good references, blueberry. I mentioned in a previous post that when Xanax users were switched, unbeknowst to them, to the generic, many experienced withdrawal. As I also mentioned before, my 25 years of experience in the pharmaceutical industry as a chemist biases me against generics. The criteria for "equivalence" are not enough to call the brand and generic equally potent, IMSO. Generic houses try to make the lowest quality med that can be legally sold...maybe not something you want to count on when you are in great emotional distress.
Posted by RobertDavid on May 14, 2006, at 22:24:50
In reply to Re: Generic vs Brand...evidence emerging..., posted by bassman on May 14, 2006, at 19:43:36
Good information. I pay the money for brand klonopin vs generic (and it's not cheap). I'm certain brand works better.
Posted by Phillipa on May 14, 2006, at 22:25:35
In reply to Re: Generic vs Brand...evidence emerging..., posted by bassman on May 14, 2006, at 19:43:36
Isn't there a 20% valiance up or below the real med? And the binders do they make a difference? Love Phillipa
Posted by RobertDavid on May 14, 2006, at 22:28:44
In reply to Re: Generic vs Brand...evidence emerging... » bassman, posted by Phillipa on May 14, 2006, at 22:25:35
> Isn't there a 20% valiance up or below the real med? And the binders do they make a difference? Love Phillipa
That's what my doctor tells me (who is also a reasercher/scientist). He said when klonopin went generic lots of patients had significant issues.
Posted by Phillipa on May 14, 2006, at 22:53:54
In reply to Re: Generic vs Brand...evidence emerging... » Phillipa, posted by RobertDavid on May 14, 2006, at 22:28:44
I heard that about klonopin but valium seems to act the same. Oh and a pharmacist told me Greenstone makes real xanax and they have two sides one for real brand and the other labeled generic but the real med. Love Phillipa
Posted by RobertDavid on May 14, 2006, at 23:17:16
In reply to Re: Generic vs Brand...evidence emerging... » RobertDavid, posted by Phillipa on May 14, 2006, at 22:53:54
> I heard that about klonopin but valium seems to act the same. Oh and a pharmacist told me Greenstone makes real xanax and they have two sides one for real brand and the other labeled generic but the real med. Love Phillipa
I'm a true believer about using brand klonopin, but do believe that generics are fine with many meds. Perhaps valium is one that generics are okay, I really don't know. I've heard other stories that suggest brand is better with xanax, but I don't have first hand knowlege/experience with it.
Rob
Posted by Phillipa on May 15, 2006, at 0:02:33
In reply to Re: Generic vs Brand...evidence emerging... » RobertDavid, posted by Phillipa on May 14, 2006, at 22:53:54
Robert I have experience with the xanax both brand and Greenstone. They're the same or were as the companies keep changing and merging. Love Phillipa
Posted by Deneb on May 15, 2006, at 1:32:38
In reply to Generic vs Brand...evidence emerging..., posted by blueberry on May 14, 2006, at 18:33:25
I don't like generic Wellbutrin SR, but not because it doesn't work the same (I can't really tell anything really with or without the Wellbutrin), but because I need to keep it in it's original container, with the moisture absorbent packs. What happens if I don't keep it in there with the moisture absorbing packs? Will the active ingredient break down?
I don't like generic Wellbutrin because of that. I keep worrying about the moisture.
Deneb*
Posted by madeline on May 15, 2006, at 4:44:15
In reply to Generic vs Brand...evidence emerging..., posted by blueberry on May 14, 2006, at 18:33:25
The difference between generic & name brand drugs has long been recognized in the field.
The difference can be especially acute for drugs that have a very narrow therapeutic range (Coumadin and digoxin to name two examples).
For these drugs, the standing order is that once a patient is started on either the name brand or generic, then the patient cannot be switched, even if the physician indicates that a switch is okay.
So, I would advise that this policy be generalized.
If you start on name brand, stay on name brand. If you start on generic, stay on generic.
Sounds simple right? Not really.
Some insurance companies mandate a switch once a generic becomes available.
Some physicians compound the problem by dispensing samples of name brand drugs.
Some pharmacies are not required to tell the patient that a switch has occurred.
So, you have to be vigilant and be your own advocate. Insurance companies can be dealt with (some pharmacies will do this for you). Don't accept samples if a generic is available. If your pills look different, they are different - check before you leave the pharmacy.
Now, not following my own policy, I switched from Prozac to generic fluoxetine without incident and ended up saving about $1000 a year.
Posted by yxibow on May 15, 2006, at 5:17:33
In reply to Re: Generic vs Brand...evidence emerging..., posted by Deneb on May 15, 2006, at 1:32:38
> I don't like generic Wellbutrin SR, but not because it doesn't work the same (I can't really tell anything really with or without the Wellbutrin), but because I need to keep it in it's original container, with the moisture absorbent packs. What happens if I don't keep it in there with the moisture absorbing packs? Will the active ingredient break down?
>
> I don't like generic Wellbutrin because of that. I keep worrying about the moisture.
>
> Deneb*All medications intended for long term storage should be stored at a reasonable room temperature, not in the bathroom cabinet as often people do, and away from humidity.
It isn't just your generic Wellbutrin -- propranolol tends to crumble if it isn't kept at an average temperature. The silica gel pacs are in brand name medication as well, they are there to absorb moisture and have been used for many years.
I don't think you need to worry all that much if you keep medication somewhere betweeen 50 and 75 degrees say, and a low humidity -- i.e., not on the back dashboard of a car or something where it could melt.
You don't have to keep it in its original container if you ask your pharmacist for some extra silica gel pacs -- you can also order them quite cheaply on Ebay if you want to put your medication in another bottle. But for memory's sake its best to keep medications in their original bottle so you don't confuse it with other medications and can prove you're the original owner of it if stopped by law authority anywhere.
Posted by cecilia on May 15, 2006, at 5:37:23
In reply to Re: Generic vs Brand.. Medication storage » Deneb, posted by yxibow on May 15, 2006, at 5:17:33
It can be pretty hard to keep your meds between 50 and 75 degrees in the summer if you don't have air conditioning (or if you do but leave it off when you're at work). And of course if they're sitting in the mailbox all day they're probably totally deteriorated. And in the winter, cold probably ruins some of them too. Makes you wonder how many of us may have failed med trials because there was something wrong with the meds, not us. And of course, with the generic vs brand, with a HMO they won't even stock the brand if a generic is available, so you'll never know if the brand might have been better. Cecilia
Posted by bassman on May 15, 2006, at 6:56:08
In reply to Re: Generic vs Brand...evidence emerging..., posted by Deneb on May 15, 2006, at 1:32:38
Please don't worry about the moisure:
“Product stability data were obtained for this formulation stored for 5 months under accelerated conditions (40° C. and 75% relative humidity). The tablets retained 99.5% potency after 5 months of storage at 40° C. and 75% relative humidity”.
http://freepatentsonline.com/6893660.html
40 C is 104 degrees Fahrenheit, so that is pretty warm, and 75% RH is quite humid.
The little ol' desiccant pack is useless after you break the seal on the bottle...it really is there to keep the product stable during manufacture (so they don't have to only make Wellbutrin tablets when it is a nice day) and to keep the tablets dry until you open the bottle. Doing a quick calculation, you have at least 2 years at to use the tablets if you take no precautions and keep them (as has been mentioned) out of your bathroom or in your car in the summertime, and in a bottle. Since you probably use the tablets up in 30 days, no problem at all. If it makes you feel better, take the desiccant pack out of the bottle and throw it in the can and say, "there!!" (that's what I do-minus the comment).:>}
Posted by Larry Hoover on May 15, 2006, at 10:09:26
In reply to Re: Generic vs Brand...evidence emerging..., posted by bassman on May 14, 2006, at 19:43:36
> Good references, blueberry. I mentioned in a previous post that when Xanax users were switched, unbeknowst to them, to the generic, many experienced withdrawal. As I also mentioned before, my 25 years of experience in the pharmaceutical industry as a chemist biases me against generics. The criteria for "equivalence" are not enough to call the brand and generic equally potent, IMSO. Generic houses try to make the lowest quality med that can be legally sold...maybe not something you want to count on when you are in great emotional distress.
I don't remember the circumstances well enough to find what I'm talking about when I Google it, but I recall hearing about a company facing charges for falsifying the data used to support applications for substantial equivalency/bioequivalency of generic meds. Maybe 6-9 months ago? This company was one that did the testing, not the pharmaceutical manufacturer themselves. What I recall reading was that they simply fabricated their data for some drug trials. No experiments were done.
I can't find any hint of the story. Does anybody remember reading anything like this? In the back of my mind, I'm fearing the information has been suppressed. Or maybe I just dreamed the whole thing?
It would have been in the trade mags, wouldn't it, bassman?
Lar
Posted by Larry Hoover on May 15, 2006, at 10:20:48
In reply to Re: Generic vs Brand...evidence emerging..., posted by bassman on May 15, 2006, at 6:56:08
> Please don't worry about the moisure:
>
> “Product stability data were obtained for this formulation stored for 5 months under accelerated conditions (40° C. and 75% relative humidity). The tablets retained 99.5% potency after 5 months of storage at 40° C. and 75% relative humidity”.The US military funded some extensive testing of drugs that had been in storage. They've got stuff that's been stored away since the Vietnam war, maybe earlier. They wanted to know, once and for all, whether drugs "expire" or not. It would have been hugely expensive to keep track of and to replace all the drugs that they keep on hand.
If I recall correctly, less than 1% of the stored meds had deteriorated such that they were not safe to use. Some antibiotics were on the "gotta replace these" lists, as was acetominophen (Tylenol). Or was it aspirin? Maybe a couple of others.
That said, leaving your drugs in the car on a hot day while you continue to shop elsewhere (I usually do groceries after the pharmacy stop) could have destroyed them. It can hit 160 in a closed car, on a sunny day. All you can do is to try and maintain reasonable storage conditions. And we should change the name of the cabinet in the bathroom. There is no worse place to keep medications, than in the bathroom.
Lar
Posted by bassman on May 15, 2006, at 10:48:02
In reply to Re: Generic vs Brand...evidence emerging... » bassman, posted by Larry Hoover on May 15, 2006, at 10:09:26
No, Lar, no-you are absolutely correct. Actually, the best one was several years ago when a big name generic house (damn, I can't remember the name, but you'd know it if I wrote it)[Barr??] really screwed the industry. Their formulation of a drug couldn't pass bio-equivalence, so they bought some brand name and used that in their trials. Cool idea, hunh? Then the FDA decided everyone in the pharmaceutical world was a crook and started looking very carefully at analytical data. Before that time, it was asumed the scientists in the pharmaceutical industry wouldn't try anything that unprofessional/criminal.
This is the end of the thread.
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