Brand Name vs Generic Drugs - The Differences Are Real, The Studies Prove It

Remember: Nobody on this site is a doctor, therapist, or a pharmacist. Know your sources! Crazy Meds is not responsible for the content of sites we provide links to. We like them, but what's on those sites is their business, not ours.

We comply with the HONcode standard for trustworthy health
information:
verify here.

Brand Name Medications vs. Generic Drugs: The Differences Are Real.

It is absolute BULLSHIT that a generic medication is always the same as the brand name drug! There can be a difference, a big difference for some people. I'm backing up that claim with scientific research as well as personal experiences. We've been told since forever that there is no difference between brand and generic drugs. Once again I'll be exposing the lies of the big pharmaceutical companies (this time the manufacturers of generic drugs) and the FDA.

I provided you with the generic name for each drug, and I list the generic names in the navigation panel of this site for all meds. If a generic version is available, you may not have a choice, that is what your HMO or insurance carrier is going to demand you take.

The law of the land in the US is there can be a plus or minus 20% bioequivalence of the active ingredient! "FDA still uses the plus-or-minus-twenty percent test to determine blood serum bioavailability (i.e., the amount of active ingredient in the blood) over a period of time has to come within plus-or-minus twenty percent of that which is observed when the innovator’s drug is ingested." This is from an overview of the Hatch-Waxman Act of 1999, the last major overhaul to patents involving pharmaceuticals. I've been all over the FDA's Office of Generic Drugs site looking for that 20% figure myself, but all I could find were weasel words. Amidst all of the hard & fast numbers in the FDA's Guidance for Industry Bioavailability and Bioequivalence, they're pretty damn vague as to the exact bioequivalence and bioavailability required when comparing "pioneer" drugs with generics! Thanks to the Freedom From Information Act, they don't seem to be keeping it online anywhere.

Hey, this isn't just some rant that I'm just pulling out of my ass. An overall review of this issue found several generic psychoactive medications to be less effective than their brand-name counterparts. Many didn't meet their 20% bioequivalence standard. Does the FDA even monitor for that? No! It's on the freaking honor system!

To make matters worse they just test for the +/- 20% on healthy volunteers! Here's another recent article pointing out that obvious problem. And what do they test for? That everything is absorbed into their bloodstream properly, is metabolized at the same rate, and you piss and/or crap all of the remnants out in the same amount of time. There's not a damn thing evaluated about how well a generic works, because they don't try them on with brain cooties, and certainly not to test for efficacy. They don't even do any freaking brain scans if such are available to compare how the generic hits various parts of one's brain with the brand medication. Maybe later, after the generic is approved (see below for some studies I found for such), but not to get it approved.

This study found that the easier insurance companies made access to brand-name medications for the consumer, the more likely said people were to keep taking their medications.

Not only that, manufacturing processes can differ. Inactive ingredients (i.e. dyes and fillers) can differ. Mostly the dyes. You can be fine with the coloring used by the original brand, or even used by the manufacturer of one generic, but not those used by another manufacturer. That problem is pointed out all over the place.

Does that mean the brand name is better? Not always. Like everything else with these crazy meds, there are pros and cons with all things. If you started out on a generic and don't have any problems with it, great! Stay with it. Does a change to generic automatically mean you'll have a problem? Nope. At least not if the manufacturer is producing a quality product. Several studies referenced below point out that problem as well. I've gone from brand to generic and with one exception the only times I've had problems are when the manufacturers are making crap products. But if your pills changed color, shape, whatever and the meds don't seem to be working correctly any longer, then head over to the page with links to pill identification sites and see if you can get your pharmacist to order your meds from that same manufacturer, and/or your doctor to prescribe brand only ("Dispense as written").

Some examples from the world of consumer experience and scientific research showing how brand name medications are superior to their generic 'equivalents':

A group of doctors found a whopping 31% reduction in the the amount of phenytonin in the systems of their patients after switching to the generic from brand Dilantin. Why did they notice? Because of the increase in the seizures those people were having. That's far below the 20% allowed under the Hatch-Waxman act of 1999. The seizures abated after the people were switched back to brand. Another study also reported different serum concentrations. Although vague "adverse effects" were mentioned, the differences in the amount of the drug in people's system were due to, are you ready? "...the reported difference in capsule content between the generic and brand-name lots used in this study." Bioequivalent my ass.
People switched from brand Lamictal to generic lamotrigine also lost seizure control. As above, once switched back to the brand most of them regained their seizure control. If the lamotrigine in this case was manufactured by Apotex, my guess is the differences in bioequivalence, bioavailability and/or pharmacological equivalence, which don't have a strict numbers that I could find anywhere on the Byzantine Health Canada site, were just enough to set people off. This Danish study gives some hard numbers from their manufacturer. My personal experience with Apotex products has been entirely positive, and I'm rather sensitive to these things. As per this Canadian study on the use of generic anticonvulsants in epilepsy, when it comes to drugs that have a a narrow therapeutic index, "Although generic AEDs [anti-epileptic drugs] are lower in price, possible increased side effects and morbidity and the need for closer monitoring could partially offset the cost savings. The results of our survey highlight significant unawareness of the process of generic substitution among both patients and neurologists and reveal a general level of discomfort among neurologists to prescribe generic AEDs."

In my own experience I had no problems with Teva's lamotrigine after switching from GSK's brand Lamictal. When my pharmacist got a batch of Dr. Reddy's lamotrigine it was seizure city. They put aside some Teva for me and other people who've had the same problem.
Of course when the names of the companies are involved you can tell who paid for the studies, and so you can see that some generics aren't that bad. Or at least meet that 20% variation, which will be good enough for some people. Here we have a study that shows two out of three named generic carbamazepine have the required bioequivalence as Tegretol. Note that even with the generics manufacturers paying for the study, which we all know that will skew the results in favor of the study's sponsor, one unnamed generic still failed! And this study was testing only for bioequivalence, and not how well they worked. Who knows how many people flipped out because of the wildly difference serum levels.
Twenty percent huh? Again, I don't know what the standard is in Canada, but this study found that 13-20% of people with epilepsy were forced to switch back from the generic version of their anticonvulsants to the brand-name versions because of breakthrough seizures. I wonder if the two numbers are related? Probably not. The same wasn't true for other classes of medications.
In a survey of over six thousand neurologists in the United States had the same sad data. Only three hundred responded, so the results are likely to be skewed against generics. When switching from brand to generic 67%! of neurologists reported patients with breakthrough seizures. Fifty-six percent reported an increase in patient side effects. Most telling of all is the statistic of 231 neurologists who think that the 20% bioequivalence standard is a load of crap. The sad part is why aren't they doing anything about it.
It's not just in the United States and Canada. A survey of neurologists in France found most of the doctors uncomfortable with generics and, wow, reports of breakthrough seizures. A group of Spanish doctors reviewed the available literature and thinks that generic AEDs aren't that hot of an idea. Another group of Spanish doctors did a cost-benefit analysis. The results: generics may be cheaper, but you get what you pay for. They think it would wind up costing more because of breakthrough seizures and similar adverse reactions.
The Italian League against Epilepsy takes the stance in line with my own (two years after I published mine): starting on the generic is fine, don't switch from brand-name med if you started on the brand-name med, when in doubt go with the brand-name drug. A pharmaceutical researcher in Israel concurs with this practice.
Benzodiazepines - as a class most people can't tell the difference between brand and generic. But benzos are one of the simplest and safest meds around, other than drug-drug interactions that usually make the one med or the other unexpectedly work better, nothing much happens with benzos. So if you're paying out of pocket, you may as well ask for the generic. If your HMO or evil, uncaring insurance carrier demands you take a generic benzodiazepine, just go along with it. The one exception to this is Klonopin. There are some forms of generic clonazepam that are not as good as the brand, and the brand is just superior over all. But how many of you have ever had brand name Klonopin with the 'K' punched out in the center of the pill? That's what I thought. We've had generic versions that are good and we've had generic versions that are just complete shit sugar pills. Sorry, too many pills, too much memory weirdness to give you any sort guide as to which manufacturers to avoid. But the sad fact is that there's a lot of clonazepam out there that is practically worthless, and the FDA doesn't seem to care one way or the other about it. I found one old study when the bioequivalence standard was only 75% and generic diazepam vs. brand Valium didn't even meet that!
We here in the industrialized world can bitch about insurance companies and HMOs dicking us around between brand and generic. At least we have modern medications to complain about. In poor-as-dirt Mauritania phenobarbital is a first-line drug to control epilepsy and almost 14% of the stuff on the market is crap. Either the tablets were underdosed or a filler with potentially dangerous side effects was used.

On to other brain cooties. Obviously anyone who is bipolar will be affected by the problems with anticonvulsants. Fight tooth and nail for branded Lithobid, Eskalith and even the yummy (and I mean that in a non-sarcastic way, Mouse found it to be quite tasty and orangelicious) lithium citrate syrup. Take a look at this study testing the various products available from the same manufacturer releasing differing amounts of lithium in different batches, and not everything labeled "sustained release" really was. Yow! This explains why I've read reports on support groups about problems people have had when switching from brand-name to generic and between different brands of generics. I've had at least one good report regarding Roxane's generic lithium products. Ask your pharmacist for Roxane if you can't get the brand.
Joe and Terry Graedon over at The People's Pharmacy have been collecting reports of problems with generic drugs of all sorts for some time. After hundreds reports of problems with Teva's Budeprion XL (generic for Wellbutrin XL) they had it tested and, surprise!, the Teva generic wasn't close to bioequivalent. We've had a similar volume, but we've lost a couple versions of our forum. As I've pointed out before, this exact problem was brought up before the FDA and the FDA's response was: "You people are crazy, all American generics are fine and dandy."
Here is a report of twenty people who were unknowingly switched from Celexa to citalopram. Within two days to two months their anxiety symptoms were back and/or they had new and improved side effects. When switched back to brand-name Celexa they were back to where they were before a couple days to three months later.
When it comes schizophrenia, the standard antipsychotics went generic too far back for anyone to care. There is only one atypical antipsychotic that has a generic on the market in the U.S. as of this writing: Clozaril (clozapine). Clozaril was the first atypical, the antipsychotic that affects the most receptors and is thus the most effective for the forms of schizophrenia and schizoaffective disorder that don't respond to anything else. It also has so many nasty side effects that there is a registry of people on it and many doctors and clinics just don't want to deal with it. So, what happens if someone switches from brand-name Clozaril to generic clozapine? Seven people with treatment-resistant schizophrenia were inadvertently switched from Clozaril to clozapine. They were in a long-term residential facility. The results: "All seven experienced a rapid and profound deterioration after the switch to the generic formulation. Five patients required hospitalization. All patients responded well when brand-name clozapine was reinstated." Yow! Then again, we can see in this small, but long-term study that was paid for by Zenith Goldline (now IVAX), how seventeen inpatients who were switched from brand to Zenith Goldline's generic did just fine. Unfortunately as Zenith Goldline doesn't exist anymore, who knows if the IVAX product would be the same. Once again, prudence is cautioned and the voice of sanity is argued: starting with the generic is fine, but don't you dare switch from brand if someone is stable on Clozaril!
Here's Nick Holland's report of comparing generic methylphenidate vs. brand Ritalin. Stick with brand, folks, even if it does cost more. Nick tells you why and how you should fight with your doctor to make sure you get brand and not generic. Even Dr. Drummond in The Complete Guide to Psychiatric Drugs caves on Ritalin while he totes the party line on generics elsewhere. He writes that methylphenidate is the one strange exception to the generics rule. My guess is Dr. Drummond had his fill of shrill parents of children with ADHD complaining about their kids bouncing off of the ceiling when the generic didn't work half as well as brand-name Ritalin.
Generic drugs rarely, if ever, have their own PI sheet. If you're reading this site that's not much of a problem as you can look up the PI sheet for the brand name drug. But that doesn't tell you everything. The PI sheets I have here won't tell you which dyes and fillers are used for the generic pills in front of you. And as the above cases have shown, many generics will have an increased rate of, if not completely different side effects. Something like that would need to be on a separate PI sheet, something I certainly couldn't host or even link to. Then we get into people who don't have or even think to look up this information on the Internet, or have Internet access but the information isn't available in their local language. A small study done in Saudi Arabia found only 16% of what PI sheets were provided in generic drugs of all types, including generic fluoxetine, conformed with the British National Formulary. With all the links I have to official PI sheets and similar information from the US, Canada, Britain, New Zealand, South Africa and random other countries when I can find it, little wonder that this site is becoming increasing popular in Saudi Arabia and surrounding countries.

Here is a much better study showing a brand of generic carbamazepine (Epitol) that is just as effective as Tegretol. It's randomized, double-blind and crossover. They were looking at effect as much as serum levels. Forty people over three months is decent data. Not all generics suck!

One of the members of an online support group I was a part of took generic fluvoxamine maleate and responded well to it for awhile. The pharmacy was out when she had to get a refill, so they gave her brand name Luvox instead. She had a nasty reaction to it. She responded much better to the generic form than the brand name form. For her the generic was better. This would be the case for many people who metabolize medications much more slowly than the general population. E.g. senior citizens. Who love their generic medications.

Face it, generics cost less. There's no point in linking to a bazillion DUH! studies on that one. I've gone from paying around $1,000 a month to under $600. If it weren't for the generic protriptyline costing $360 a month I'd be paying a lot less. The innovators of brand-name drugs do the worst possible things to extend the lives of the patents on their meds to keep those meds from going generic. The drug companies hold off on approvals for important new applications for the medications, because the later the approval the longer the drug stays on patent. I'm all for stringent testing, if they actually did such. Big pharmaceutical companies will add bullshit, perhaps dangerous new applications for the same reason: just to extend the patent. There's a dangerous trend of disease mongering. And don't get me started on all those ads for expensive atypical antipsychotics to treat bipolar disorder when anticonvulsants and lithium are the way to go. Generic lithium may be a crapshoot, but if you start on a generic anticonvulsant for bipolar disorder, you might be OK. Better switching from generic to brand of an anticonvulsant than sticking with an antipsychotic as monotherapy for bipolar disorder.

There are some generics out there close enough to the brand-name drug that will work well enough. But the key is, start on generic if the generic is available. This study using step-therapy edit (i.e. be as cheap-ass as possible) found that it's less expensive to start with a generic rather than switching from brand. Once again: DUH! So if someone comes into the HMO from outside and was on brand, they should stick with brand if possible.

I've known plenty of people who've tried brand and generic meds. Some have noticed a difference, some haven't. As I wrote above Teva's generic lamotrigine works for me. Roxane's protriptyline works as well as brand Vivactil, even if there isn't that much of a price difference. Other than Dr. Reddy's lamotrigine the only other problem I'm having as of this writing (22 May 2009) is with generic topiramate. The pills seem inconsistent, in that some days it feels like I've taken more than usual, some days less, and some days it's nice and Goldilocks and just right. That is a problem people are reporting all over the place, regardless of manufacturer.

The fact is the difference is real. It exists. It is not in your head if you notice a change. If you change from brand to generic, or even from one generics manufacturer (or 'brand') to to another and notice new side effects, change back if you can! Otherwise it's a matter of putting up with the side effects just like any other new med and hoping they're the type that go away after a couple weeks. But if the generic doesn't work as well as the brand name and you can't change back, see if you can get a dosage adjustment, up or down. The magic number is 20%, but a lot of meds don't come in 20% increments. You'll be lucky if you can get a 25% difference somehow. If the med comes in a tablet and it's immediate release, you have the option of splitting one to get a 25% difference. But that might mean getting some wacky combination of big and small pills that could wipe out any potential savings made by switching to the generic. Hmmm, don't some of those studies up there show that the cost savings are wiped out by such problems?

Isn't that crazy? Of course it is! These are crazy meds! They're almost as crazy as the US health care system, which is way crazier than any of us. The ironic part is this is one of the few times we've been in the forefront of changing doctors' minds and the position of the medical establishment. Unlike the initial issues with CYP metabolism, where it was antidepressants front and center, this time the doctors have glommed onto epilepsy as the main concern. Which, by extension, includes the bipolar. Although the problem with Budeprion XL is what popularized the issue of brand vs. generic differences, you may have noticed how the vast majority of articles I've found in the medical literature deal with epilepsy. One of the articles I cited way up there regarding the testing of healthy volunteers, The Epilepsy Battle in the War Between Brands and Generics, puts it this way:
The current battle primarily is centered on antiepilepsy drugs, but manufacturers of immunosuppressants for transplant and cancer patients and arrhythmia drugs are also skirmishing.
That article it worth a read for its balanced presentation of both sides of the brand vs. generic issue.

I wrote about Joe and Terry Graedon and how they lead the way calling attention to the problems with Budeprion. You can report a problem with any generic medication on their website. Unfortunately all reports from consumers since 2007 are lumped together, regardless of condition or medication, so you can't easily find reports for specific medications.

Oh, and about those cases where the switches were "inadvertent." Seems like there's about a 33% chance that a doctor or pharmacist will misidentify a pill.

Read about the experiences other people have had with brand name and generic drugs on our Brand vs. Generic Board. Add your own.

The Overlords of the 12 Zernox Galaxies have compelled me through messages in the Sunday Chronicle to beg you for funds to help squash the Arachnoid uprising. So if this site has been of use and/or amusement to you, we'd be grateful if you could donate some cash.

Visit the Support Page for how you can help if you don't have any money laying around. This includes reviewing Crazy Meds for Amazon.com and/or

There's also our Mental Mall, to purchase some books or t-shirts.

Crazy Meds Home Crazy Meds Talk About Antidepressants About SSRIs About Anticonvulsants / Mood Stabilizers About Atypical Antipsychotics About Benzodiazepines About Stimulants Finding a Doctor Sites with More Information Support Group Sites About Crazy Meds Visit my autistic - bipolar - epileptic blog

Take care, and keep taking your crazy meds!

Hey, did you find this page all by itself through Google or some other search engine? Great! But to really appreciate the entire site, you need to start here.

Dead tree references:

End of books used for this article.

----------------------------------------------------------------------------------------------------

Created Saturday, November 8, 2003

Last updated Saturday, December 05, 2009

Almost all of the material on this site is copyright Â© 2002, 2003, 2004, 2005, 2006, 2007, 2008 and 2009 Jerod Poore. Except, of course, the PI sheets, those are the property of the drug companies who developed the drugs the sheets are about. And any documents that are written by other people which may be posted to this site will remain the property of the original authors. You cannot reproduce this page or any other material on this site outside of the boundaries of fair use copying without the express permission of the copyright holder. That's usually me, so just ask first. That means if want to print out a few pages to take to your doctor, therapist, counselor, support group, non-understanding family members or something like that - then that's OK to just do. Go for it! Please. As long as you include this copyright notice and the following disclaimer, I'm cool with it.

All rights reserved. No warranty is expressed or implied in this information. Consult one or more doctors and pharmacists before taking, or changing how you take any neurological and/or psychiatric medication. Your mileage may vary. What happened to us won't necessarily happen to you. Nobody on this site is a doctor, therapist, or a pharmacist. We don't portray them either here or on TV. Only doctors can diagnose and treat an illness. Some doctors tend to get pissed off by patients who know too much about medications, so tread lightly when and where appropriate. Diagnosing yourself from a website is like defending yourself in court, you suddenly have a fool for a doctor. Don't be a cyberchondriac, thinking you have every disease you see a website about, or that you'll get every side effect from every medication. Self-prescribing is just as dangerous. All information on this site has been obtained through personal experience, the experiences of my friends, the experiences of people reported on online support groups, and from sources that are referenced throughout the site. Know your sources! As such the information presented here is not a substitute for real medical advice from your real doctor, just a compliment to it. No neurologists, psychiatrists, therapists or pharmacists were harmed in the production of this website. All brand names of the drugs listed in this site are the trademarks of the companies listed after them in the pages about the drugs, even though those companies may or may not have been acquired by other companies who may or may not be listed in this site by the time you read this. Always read the PI sheet that comes with your medications and never ever throw them away. If you didn't get a PI sheet, demand one. Loudly. Crazy Meds is not responsible for the content of sites we provide links to. We like them, or they're paid advertisements, or they're something you should read to make an informed decision about a particular med. Sometimes they're more than one of those things. But what's on those sites is their business, not ours. Very little information about visitors to this site is collected or saved. And from time to time I do look at search terms used to find it in an effort to make the information I present more relevant. Use only as directed. Void where prohibited.

"Everything is true, nothing is permitted." - Jerod Poore