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Generic Wellbutrin Doesnt Work As Well As Name Brand


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#1 maintainin

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Posted 12 October 2007 - 02:54 PM

This article seems to validate what folks taking generic wellbutrin have been saying for awhile. From MSNBC:

Report questions generic antidepressant


By Jacqueline Stenson
Contributing editor
MSNBC


For seven years Linda Douglas has been treating her depression with the antidepressant Wellbutrin, first with a twice-a-day version and then later with a more convenient once-a-day pill called Wellbutrin XL. The drug, she says, "renewed my joy for living."

All that changed earlier this year when she switched to a generic version of Wellbutrin XL 300 milligrams to save money. Instead of paying $250 for a three-month supply of the brand drug, she was paying just $53. The cost savings were welcome, but Douglas, 48, a telecommunications project manager in Columbia, Md., says the depression returned during the six months she took the generic antidepressant.

"I was questioning, did I take my medication today? Something's not right," she remembers. Occasionally she'd experience symptoms of a panic attack, or worse. "The suicidal thoughts came back," she says. At that point, Douglas started to suspect there was something wrong with her medication, and in August asked her doctor to switch her back to the brand-name version. She says she felt better within days.

New test findings by ConsumerLab.com that were released to MSNBC.com showed that one of a few generic versions of Wellbutrin XL 300 mg, sold as Budeprion XL 300 mg, didn't perform the same as the brand-name pill in the lab. The results offer a possible explanation for the experience of Douglas and reportedly hundreds of other people who wrote to a syndicated newspaper column called The People's Pharmacy with related complaints, says Dr. Tod Cooperman, president of ConsumerLab.com, a Westchester, N.Y.-based provider of independent evaluations of health and nutrition products.


Though experts agree the majority of generic drugs perform the same as their pricier brands, some say the results raise questions about whether that is always the case.

"When we saw the results we were shocked," says Cooperman.

Marc Goshko, executive director of legal affairs at Teva Pharmaceutical Industries, which sells Budeprion XL 300 mg, says the drug met all requirements of the Food and Drug Administration, including showing that the drug performed similarly to the brand in the lab and also was released into the bloodstream of healthy volunteers at the same rate. He did not cite specifics of that research.

In an e-mail response, FDA spokesperson Sandy Walsh said, "We are investigating the complaints regarding generic Wellbutrin, but cannot offer specifics at this time."

The FDA does not require generic drugmakers seeking approval to do clinical trials of their drugs on hundreds or thousands of people as is required for brand drugs. Instead, the agency requires lab data and "bioequivalence" testing in about 24 to 36 healthy volunteers showing that the drug appears in the bloodstream in a similar manner to the brand, says Walsh.

Dr. Sidney Weissman, a member of the board of trustees of the American Psychiatric Association and a professor of psychiatry at Northwestern University in Chicago, says that while he hasn't heard complaints about generic Wellbutrin XL himself, the findings are cause for additional investigation. "Is the FDA method for approving these different methodologies adequate?" he says.

"I, for one, am concerned," Weissman adds. "This raises questions for me on the reliability of FDA testing for these types of drugs."

Consumer complaints
ConsumerLab.com began investigating after Joe and Terry Graedon, authors of The People's Pharmacy column, approached them with the consumer complaints. "In almost all cases people were saying their depression returned," says Joe Graedon, a pharmacologist. While the Graedons had received complaints from readers about generic drugs before, "we had never received this volume of response," he says.

For the testing, ConsumerLab.com purchased both the original Wellbutrin XL 300 mg sold by GlaxoSmithKline and the generic version sold by Teva, the same one that Douglas took and that many other readers complained about, and had six samples of each drug analyzed. While both drugs contained the stated amount of the active ingredient, bupropion, "dissolution testing" showed that the generic drug, which has a different time-release mechanism, released the active ingredient into a solution at a quicker rate.

"The Teva product released nearly half of its ingredients in the first four hours," says Cooperman. "The original Wellbutrin released 25 percent."

Within the first two hours, 8 percent of the original Wellbutrin had dissolved, compared with 34 percent of the Teva product, according to Cooperman. By 16 hours, both drugs had released all the medicine.

If the active ingredient is released more quickly into a patient's bloodstream, that could mean there is less medication available to the patient later, which may explain why people like Douglas experienced a return of their depression, Cooperman says. It also may explain why some readers who wrote in complained of more side effects, such as headache, irritability and nausea, given they may have received a higher dosage of the medicine upfront, he says. "Too much Wellbutrin can cause side effects, even the potential for seizure," he says.

Andrea Hofelich, a spokesperson for the Generic Pharmaceutical Association in Arlington, Va., called into question the validity of the ConsumerLab.com findings, saying the company's testing was "inadequate" compared to what the FDA requires for a generic drug to hit the market.

"The FDA is the world's gold standard for reviewing brand and generic medicines," she says.

Teva's Goshko also took issue with ConsumerLab.com's conclusions: "How the product dissolves in you is really the correct question here, not how it dissolves in a test tube."


But Mark Boesen, a pharmacist in Phoenix and a spokesperson for the American Pharmacists Association, says the findings offer "a reason for pause." Since the research was only done in the lab, not in real patients, the findings aren't conclusive, he says. Still, "the combination of anecdotal evidence and the conclusions of the in vitro study would lead one to believe that patients might receive a different therapeutic outcome from the two medications."


ConsumerLab.com also tested two generic versions of a twice-a-day Wellbutrin SR and found that variations were within FDA limits of acceptability.

Cooperman says he could not determine what the FDA variation limits are for the once-a-day extended release products. "We haven't seen anything published stating what's acceptable," he says. The FDA declined to comment specifically on the ConsumerLab.com report.

But given that the generic drug was approved by the FDA, "it appears that they are giving a lot of leeway in how the drugs are released," Cooperman says. "It would seem very difficult to imagine that the results we saw would be acceptable results."

The FDA's Walsh says the agency "cannot offer any examples where generics have been shown to not perform as expected" and that "health professionals and consumers can be assured that FDA-approved generic drugs have met the same rigid standards as the pioneer (brand name) drug."

Call for monitoring
But as the FDA plans to speed up approval of generic drugs, Cooperman and Graedon say they're concerned about safety. Graedon says the FDA should do more monitoring of generic drugs once they hit the market and are taken by thousands of people.

Other experts interviewed for this story say that in the majority of cases, switching from a brand drug to a generic poses no problem and offers an important cost savings. But some have concerns about certain medications, especially those used to treat heart conditions and epilepsy, where being properly medicated is critical.

While generics are required to have the same active ingredients as the brand drugs, the FDA allows for some variability in the amount of the active drug. Usually that variability is no big deal, says Boesen. However, "there is a small number of medications that we do worry about switching back and forth," he says.

Doctors and pharmacists refer to these drugs as having a "narrow therapeutic index." Translation: "If you get too much you can get sick. If you get too little you don't get any benefit," says Boesen.

If at first you don't succeed, then skydiving definitely isn't for you!

Brian
 


#2 gentle sun

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Posted 12 October 2007 - 04:31 PM

Thanks a lot for the info!!

I take Buproprion (generic Wellb) I have no problem with it. Did they mean what they typed Budiprion or was that a misspell?

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#3 maintainin

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Posted 12 October 2007 - 05:03 PM

Budiprion is Teva's brand name for their generic wellbutrin. If that makes sense. Why they cant call it bupropion, which is wellbutrins ACTUAL generic name is beyond me. I'm sure alot of folks dont have problems, BUT alot of folks DO It needs to be changed. A 25% difference in release rate seems huge to me and if this still falls within FDA limits then I would be shocked. Well........actually I wouldnt. As more time goes on, the more faith I lose in the FDA. I wonder sometimes wether the publics health and welfare is really their top priority. Bottom line is people are different and as we all know different AD's affect people differently. Why wouldnt release rates? Teva needs to fix it.

If at first you don't succeed, then skydiving definitely isn't for you!

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#4 maintainin

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Posted 12 October 2007 - 05:16 PM

Just to clarify. the article isnt talking about all generic wellbutrin. There are few different companies out there making generic wellbutrin. The problem seems to be coming from the one made by Teva. If your bottle just says "bupropion" its probably not made by Teva. They are calling it Budiprion. If you go to MSNBC and read the article they do have a picture of the wellbutrin made my Teva. Of course I cant link it, but the pill does have "682" stamped into one side of it.

Edited by maintainin, 12 October 2007 - 05:21 PM.

If at first you don't succeed, then skydiving definitely isn't for you!

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#5 Burgy

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Posted 12 October 2007 - 06:59 PM

I take Teva's version of bupropion that they confusingly call Budeprion. I take 300 mg/day of the XL version. This article is interesting to me and confirms my experience when I switched from name brand to generic. I noticed more of a "kick", within just an hour, and I thought "this version must be releasing faster". I was a bit cranked up, like an amphetamine feeling. The next day, the energy spike was more mild, and the next day, milder, and so on. Within a week, I had adjusted and didn't feel any difference throughout the day. At this point, I've been on Budeprion 300 XL for several months, and I can hardly tell I'm on it, it's that smooth. The antidepressant effects are still going strong.

I guess I'm one of the lucky ones who can adjust to and tolerate a faster release version of bupropion. I can understand how people who are more sensitive to medication would get more side effects because of the faster release, and then come down and possibly crash later in the day, as the release tapers off. Maybe this has to do with liver metabolism. Maybe I have a slower liver, so the bupropion breaks down at a more consistent rate throughout the day. Maybe the ones who suffer from the faster release have faster livers. Or maybe I'm just a junkie. In any case, if you react badly to a switch to generic bupropion and don't adjust within a reasonable amount of time, your doctor can tell your insurance company that the name brand is "medically necessary" for you. This should lessen your copayment.

Edited by suburgatory, 12 October 2007 - 07:09 PM.

Posted Image We are what we think. All that we are arises with our thoughts. With our thoughts, we make the world. ~Buddha

#6 chinkes

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Posted 12 October 2007 - 07:22 PM

Since I do so much research on these things, I came across the articles about generic WBXL and decided I was only going to take WB brand. Luckily I'm still on the WB150XL which has no generic yet and my doc has authorized me to take 2 pills if/when I increase to 300XL. If I stay with 300XL then I'll have to have my doc put "Name Brand required" in order to get my mail in pharmacy to provide it. I am pretty adamant about taking name brands in general. Usually my doc gives me samples of name brand meds and I'm NOT going to switch to something else once I start the name brand. It's likely all in my head that the name brands are better, but Hey, this is all about what's in our heads, isn't it? :hearts:

#7 LA_Woman

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Posted 13 October 2007 - 04:48 PM

Interesting article, thanks for posting it Brian. I have never taken the name brand, so I have nothing to compare to. I actually just switched from 150mg SR to 200 mg SR today. When I was on 75mg and then 150mg SR both were manufactured by TEVA; however, the 200mg SR I picked up today is manufactured by "Global". I haven't seen any info about them on here anywhere. I'm hoping that is good news?!

#8 Sneezeguard

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Posted 18 October 2007 - 12:51 PM

Fellow Wellbutrinians,

I’ve been lurking this board for the past few days since that story broke last week (Fri, 10/12) about the difference between brand name Wellbutrin and the Teva generic. I have mild/moderate depression and am also a recovering alcoholic with ADD.

I’ve been taking the Teva 300 mg XL for a few months now, and it has helped with the nagging irritability and sour moods. The XL is an improvement over the two SR 150s I had been taking. I am also taking Concerta 54 mg per day which, similarly, was an improvement over the several 10 mg generic-ritalin doses I had been taking. With both the bupropion and the methylphenidate, I seem to do much better with the extended-release versions. So when I learned that the ConsumerLabs test showed there was considerable difference in the release rate between Teva and Wellbrutin, I decided to muscle up to the bar. I just got my scrip refilled with the real stuff and plan to start taking it tomorrow. (On my plan, from $0 to $45 per 1 mo supply.)

I’m keeping two important things in mind as I start. The first is my own admitted susceptibility to the placebo/power-of-suggestion factor; the second is the vested interest that drug manufacturers have in peddling brand name. I can’t say I noticed much difference when I previously tried brand-name Ritalin over generic, but methinks that the generic-versus-brand debate needs to address medications individually. I’ll be reporting back in the coming days and weeks. (I will also be copying this post to other appropriate-looking threads, so you might see it again.)

#9 sean22

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Posted 06 November 2007 - 07:58 PM

yeah my doc said brand name is better

#10 Burgy

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Posted 06 November 2007 - 08:14 PM

"Better" is a subjective term and can only be determined by your own body. I must say I was nervous about switching to generic, but my psychopharmacologist told me she only had one patient who had a negative reaction to generic, and that helped to ease my concern. When I actually gave generic a try, I liked it better than the name brand! It gave me more of a lift, which I really needed. And after about a week, it smoothed out to the point where I couldn't even tell I was on it anymore. Some people require a longer adjustment. Give generic a reasonable chance before you reject it. Just because some people had a bad reaction and put their story in the paper, that doesn't make them the experts.
Posted Image We are what we think. All that we are arises with our thoughts. With our thoughts, we make the world. ~Buddha

#11 MovingForward

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Posted 06 November 2007 - 08:19 PM

My boyfriend just pointed me to this article last week. My depression seems to come and go and had really been in full force that week. He was kind enough to help me recognize where my depression level was (I don't always recognize that I'm getting depressed). He mentioned that maybe my med wasn't working as well as I thought it was. It was then I started doing more research and that's why I'm here. I have a call into my therapist to talk to her about switching back to the name brand (if possible) to see if that will make a difference.
The path to our destination is not always a straight one. We go down the wrong road, we get lost, we turn back. Maybe it doesn't matter which road we embark on. Maybe what matters is that we embark.

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#12 Ronnie

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Posted 06 November 2007 - 11:50 PM

AHH HA... ME AND BURGY WERE RIGHT.... THE DRUG DOES RELEASE FASTER IN YOUR SYSTEM! How funny that if you scroll down to the other Generic -verses- Brand posts that are pages long... you will find out that we performed this experiment for ourselves and on myself. (Me specifically for 3 months) and came to the same conclusion that the MSNBC article stated.

Fortunately, having the medicatioin release in my system faster does not affect its effectiveness. And the longer you are on the medication, you will reach what is called a "Steady State" and it wont matter much if you skip a day or take it at a different time in the day every now and then since the medication stays in your system for a while with a slow half life from what I understand.

ALTHOUGH, and as I stated before..... if after a month or 2 and you are still having problems with the generic, then it's probably worth it to go back to the brand or change medications. I believe our mental health is much more important than trying to save money. For some of us, continued depression/anxiety can cost us our jobs and then we'd have no money to buy any medication.

Current meds: Lexapro 10mg, Wellbutrin SR 150mg 2x day
 
As needed: Restoril or Trazadone for sleep.  Klonopin infrequently, Nuvigil for shift work.
 
Previous meds I tried:  Paxil, Prozac, Cymbalta, Pristiq, Abilify, Buspar, Xanax, Depakote, Doxepin.
 
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