our personal experiences with and general comments about Wellbutrin (bupropion)
I <3 Wellbutrin
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While Wellbutrin has the potential make you happy, horny, skinny, and quit smoking, it is only consistent at making you not depressed - which probably counts as happy - and helping you to stop smoking, while being unlikely to make you gain weight or affect your libido. Weight loss and treating sexual dysfunction are off-label uses of Wellbutrin and, like most off-label uses, you only want to try it if the regular treatments don’t work, because the odds aren’t as good or the side effects are worse. Or both.
Really, Dr. Drew… oh, wait, Dr. Drew just took GSK’s money and told everyone the facts as they were known — like Wellbutrin is less likely to cause weight gain or sexual side effects than SSRIs — except for that part about taking a shitload of money from GSK. It was another doctor, who wasn’t as famous, who was repeating what the pharm reps were telling him, that Wellbutrin is the happy, horny, skinny pill. Maybe. If you don’t need it to keep from falling to the floor in a fetal position and sobbing for hours if the newspaper reprinted yesterday’s sudoku. They should have known better than that.
There’s more Wellbutrin news. On 3 October 2012 The FDA pulled the approval of the Teva/Impax 300mg Budeprion XL.1 That document spins the FDA’s actions so much it makes me dizzy. Fortunately the FDA published an additional document, Questions and Answers Regarding Market Withdrawal of Budeprion XL 300 mg Manufactured by Impax and Marketed by Teva. While this Q&A document tries to make the FDA’s inaction regarding Budeprion XL seem even less egregious, and they try to put the blame entirely on the use of a sub-therapeutic dosage in the PK testing, I like it a lot more than the straight update on their finding Budeprion XL is not, after all, bioequivalent to Wellbutrin XL. Why? Because it is much easier to tear the FDA and Teva a new one with the Q&A format and the information they provide. Unless otherwise indicated, all quoted text is from
Q3: What actions has FDA taken as a result of its findings?
A3. FDA has asked Impax Laboratories, Inc. (Impax) to voluntarily withdraw its application for the 300 mg strength of Budeprion XL (bupropion hydrochloride extended-release tablets, USP), because the drug failed to meet FDA’s bioequivalence standards for a generic drug. The company agreed to do so.
At FDA’s request, Impax and Teva ceased product distribution as of 9/28/12, and is conducting a voluntary market withdrawal (an action to remove product currently in distribution) of Budeprion XL 300 mg. Impax and Teva are notifying customers, down to the retail level.
FDA has also changed the therapeutic equivalence (TE) rating for this product in the Agency’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) from AB to BX, signifying that Budeprion XL 300 mg fails to demonstrate therapeutic equivalence to Wellbutrin XL 300 mg.
FDA recently asked each of the other manufacturers — Anchen, Actavis, Watson, and Mylan — to conduct their own studies to assess the bioequivalence of their 300 mg extended-release bupropion tablets to Wellbutrin XL 300 mg. FDA has asked these companies to submit the data from those studies no later than March 2013. FDA believes that the failure of the Impax/Teva product to meet bioequivalence standards may reflect the product’s formulation, which is unique to the Impax/Teva version of bupropion hydrochloride. FDA is also revising its guidance to industry for how to conduct premarket bioequivalence studies in generic bupropion products.
Is it the same bullshit guidance I ripped to shreds in the brand vs. generics article, or is the FDA going to take my advice now that they’ve more-or-less admitted I’ve been right all along? Oh, wait, they haven’t admitted that Dr. Stephen freakin’ Stahl and I were right. The FDA is trying to bullshit their way out of this mess…
Q11. What was FDA’s initial response to the postmarketing reports submitted in the first half of 2007?
A11. FDA re-examined the data comparing the bioavailability of the two bupropion XL 150 mg products (Wellbutrin XL and Impax’s Budeprion XL). Based on that data, FDA concluded that Impax’s Budeprion XL 150 mg was bioequivalent and therapeutically equivalent to Wellbutrin XL 150 mg. Although FDA observed differences in the pharmacokinetic profiles of these two products at that time, they were not outside of the established boundaries for bioequivalence and they were consistent with bioequivalence data for other bupropion products known to be effective. Based on the data available at the time, FDA determined that these findings could be extrapolated to the 300 mg strengths of extended-release bupropion.
Except the Impax/Teva product was outside of the given range. This is why I saved the FDA’s review of the study, a review they keep moving around and sometimes entirely remove from their site.2 Right now you can find it here. You can also look at the part of the Brand Name vs. Generic Medications that’s about the FDA and Budeprion XL, where I explain how the FDA is full of shit. The FDA is trying to make the problem entirely about using 150 mg tablets to test for the bioequivalence of 300 mg tablets, when that’s not the entire problem. The real problem has always been why Budeprion XL acts like Wellbutrin SR regardless of the dosage.
Q12. What further action did FDA take in response to these concerns?
A12. FDA continued to review postmarketing reports throughout 2007. In November 2007, taking into consideration reports of lack of efficacy, FDA requested that Impax/Teva conduct a bioequivalence study directly comparing Budeprion XL 300 mg to Wellbutrin XL 300 mg. The study protocol stipulated the enrollment of patients who reported problems after switching from Wellbutrin XL 300 mg to Budeprion XL 300 mg. Impax/Teva began the study, but terminated it in late 2011, reporting that despite efforts to enroll patients, Impax/Teva was unable to recruit a significant number of affected patients.
Q13. Why did FDA do the study in healthy adult volunteers after asking Impax/Teva to conduct the study in a targeted patient population?
A13. The Agency determined that it was important to conduct direct bioequivalence studies comparing Budeprion XL 300 mg to Wellbutrin XL 300 mg, in light of the reports that patients and health care professionals had submitted to FDA. FDA believed that the optimal patient population for those studies would be patients who had reported a lack of efficacy or unwanted side effects after switching from Wellbutrin XL 300 mg to Budeprion XL 300 mg. The rationale for this was two-fold. First, the Agency believed that such a study would better target the reported problems and thereby provide the best information as to why the drug did not appear to be effective. Second, because that patient population was taking the 300 mg strength of the drug already, this study design would not unnecessarily expose healthy adult volunteers to the higher strength of the drug, particularly given concerns that this strength might be associated with risk of seizures.
Impax/Teva, however, was unsuccessful in recruiting a sufficient number of patients who had reported a lack of efficacy or unwanted side effects after switching from Wellbutrin XL 300 mg to Budeprion XL 300 mg. Due to the continuing questions about the efficacy of the Impax/Teva 300 mg bupropion product, the risks associated with reduced efficacy in patients with major depressive disorder, and increased experience with the safety profile of the drug, FDA concluded that a small bioequivalence study in healthy adult volunteers should be conducted.
First: news to me. I could find nothing published on the FDA site about it. The only time a bioequivalence study is mentioned is in documents related to the FDA pulling Budeprion’s approval. As for the study itself, you can find it on ClinicalTrials.gov, where it was first received January 2010. It’s true that the study had to be terminated because Teva was able to find only eight people who had problems when they switched from Wellbutrin XL to Budeprion XL, and met all of Teva’s other criteria. They also planned on conducting the study in Glendale and Culver City, nowhere else, and where was the fucking publicity? The only evidence I can find of an announcement of the trial was Bioavail’s (the new owners of Wellbutrin XL — see comments below) response to it. Plus Teva gave up in March 2012, for a study that was going to end in 2015?
Oh, wait. Who the hell is going to trust Teva? And anyone who is back on Wellbutrin XL probably doesn’t want to risk going back on Budeprion XL after what they went through. Not only that, it was a double-dummy trial. That means everyone was going to get either Budeprion XL or a placebo, no matter which group they were in, every other day! Nobody in their right mind who had an adverse reaction to switching from Wellbutrin XL to Budeprion XL would agree to that. The eight people who signed up probably didn’t understand what the fuck a double-dummy clinical trial really is!
Now I’ll put on my conspiracy theory tinfoil hat: I wonder if they wanted the clinical trial to fail, just so they can sell more 150mg tablets. Two 150mg tablets are usually twice as profitable as one 300mg tablet.
Continuing with answer 13:
In 2010, FDA decided to sponsor a study to be performed in healthy adult volunteers who were not being treated with the drug. FDA developed the study protocol and a test method that could identify bupropion and very closely related metabolites of bupropion, providing more accurate information about how bupropion is absorbed and subsequently metabolized by the body. The results of the FDA-sponsored bioequivalence study became available in August 2012, and they showed that Budeprion XL 300 mg fails to demonstrate bioequivalence to Wellbutrin XL 300 mg.
And that study is where? Not PubMed. Not the FDA’s site. Nowhere Google can see.
Q17. In retrospect, were FDA’s decisions regarding the approval and ongoing monitoring of Budeprion XL 300 mg appropriate?
A17. A less cautious approach in studying the bioequivalence of Budeprion XL 300 mg could have brought the data to light earlier. The FDA-sponsored study was completed only weeks ago, which is a very short time for data from a clinical experiment to be announced to the public.
What? Less cautious? Just when you think the FDA couldn’t pile the bullshit any higher they come up with something like that. Maybe the NFL could use that line. “If we were less cautious and allowed players to play without wearing helmets, the problems with head injuries would have been brought to light much earlier.” Using a sub-clinical dosage is not the only fucking problem you morons, it’s the single pill taken by professional lab rats under fasting conditions that’s the problem. True bioequivalence can be measured only by getting people with the condition the medication treats to take the drug long enough, at the very minimum, to reach steady state.
As I keep writing, don’t just take my word for it. Read A Horse of a Different Color: How Formulation Influences Medication Effects Meghan M. Grady and Stephen M. Stahl to get the details as to why the method Impax chose to make Budeprion XL a once-a-day pill won’t work.
It’s long past time the FDA admitted they were wrong, everyone wasn’t imagining things or it was coincidental that the Budeprion XL failed, apologize, and to change their guidelines regarding bioequivalence to something realistic. But they still refuse to admit how wrong they were, so nothing else is likely to happen.
More comments about other Wellbutrin stuff below…
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In 2009 GSK sold Wellbutrin XL to Biovail, but they kept the immediate and sustained-release flavors. In 2010 Biovail bought Valeant, and liked that name better.
So GSK sold Wellbutrin XL to a company named Biovail.
Who changed their name to Valeant.
So Wellbutrin XL is a trademark of, and produced by Valeant.
While regular Wellbutrin, Wellbutrin SR, and Zyban are still GSK properties.
This is why I have that part in the disclaimer about trademark ownership being subject to change. Frequently.
In the meantime, in 2006 Biovail developed bupropion hydrobromide, a somewhat more stable form of Wellbutrin XL. They eventually sold it to Sanofi, who now market it as Aplenzin, which competes directly with Wellbutrin XL, currently owned by Valeant (nee Biovail).
I don’t know which is crazier, me or the world of big pharma. Little wonder that pharm reps rip into each other like crazed weasels on the Cafe Pharma boards.
About Sanofi and Aplenzin - the dosages of 174mg, 348mg and 522mg seem oddly precise. As the guy who bitches about dosage-critical medications you’d think I’d appreciate how much effort Biovail and/or Sanofi put into getting it right. Instead I’m immediately suspicious. Why? It’s the illusion of precision, where many people are more likely to believe an exact-seeming number than a round one. Those are the people who aren’t fooled into thinking $49.95 is significantly less than $50.00. The best example of its use is in real estate:
For example, let’s say you’re selling a home you believe is valued slightly under $1,000,000. If you were looking to position this home as an exclusive or prestigious home, then you’d want to use a rounded value such as $980,000.
If you were looking to position the home as a “bargain,” then you would want to use a more exact number such as $979,235. By using a more exact selling value, consumers believe you’ve put a lot of thought into the selling price of the home. — Money-Zine.com “Selling Your Home”
$979,995 = “That real estate agent thinks we’re idiots.”
$979,235 = “Wow, she must have given that place a colonoscopy.”
The PK data in the Aplenzin PI sheet is a mix of the usual bullshit FDA minimal requirement PK studies and some decent studies that produce useful data. Maybe Biovail’s and/or Sanofi’s R&D people determined that 174mg of bupropion HBr is the exact equivalent to 150mg of bupropion HCl, but it still looks like a $979,235 house to me.
Sanofi’s big selling points for Aplenzin are:
- If you’re taking 450mg a day of Wellbutrin or Budeprion XL it’s two pills, but with Aplenzin you only have to take ‘’one’ pill!
- There’s no generic equivalent for Aplenzin (because it’s a branded generic), so your pill won’t change size, shape, or color. In other words: you won’t get hosed by being switched to a generic product that disagrees with you.
- Which is funny, coming from a company that owns subsidiaries which manufacture generic drugs.
- Just look at the Aplenzin website if you don’t believe me.
The pharmacokinetics of bupropion and its active metabolites were a bitch to find. GSK didn’t publish shit in the PI sheets, and wouldn’t let researchers publish anything. Take a look at this table of PK data from a paper Stahl wrote on Wellbutrin. Stahl usually goes on and on about PK, but what do we get here? Obtuse statistical comparisons of the XL and SR flavors to immediate release and a notation to trust the math because the data are on file at GSK. WTF? So I had to piece everything together from the PI sheet and studies dealing with drug-herb interactions and people with renal impairments using small samples of healthy volunteers (AKA the usual suspects), and those numbers were all over the map. Especially the area under the curve (AUC) data, which I just didn’t bother with including.
The bupropion hydrobromide PK data are from the Aplenzin PI sheet. Those data are from tests done on an unpublished number of the usual suspects (“healthy volunteers” or “professional lab rats”) along with some bupropion HCl data. I included only the bupropion HBr data.
Don’t worry about actually buying one. Windows shop and share the designs you’d like to buy or find worthy of ridicule. What else are you doing now? Working? Sure you are.
1 Technically the FDA asked Teva & Impax to voluntarily remove Budeprion XL from the market, much like the way the IRS assists us in voluntary compliance with tax code. Go ahead, search irs.gov for the phrase "promote voluntary compliance", with or without quotes. I feel so much better about myself knowing I've been volunteering for my country.
2 You bet your ass I'm saving these documents as well.
If you have any questions not answered here, please see the Crazymeds Wellbutrin discussion board. We welcome criticisms of the articles, notifications of bad links, site problems, consumer experiences with medications, etc. I’m not always able to write back. Hence I never answer questions about meds via e-mail that are answered by this or other articles. Especially if they have been repeatedly asked on the forum. That’s why we write these damn things. Questions about which meds are best for your condition should also be asked on the forum; because this is a free site, so the price of admission is making things easier for somebody else searching for the same answer. We don’t deal with children on the forum or in private because after doing this for ten years I don’t have the emotional stamina to deal with kids who have brain cooties. How to contact Crazymeds. — Jerod Poore, CME, Publisher Crazymeds (crazymeds.us)
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Wellbutrin, and all other drug names on this page and used throughout the site, are a trademark of someone else. Wellbutrin’s PI Sheet will probably have the name of the manufacturer and trademark owner (they’re not always the same company) at or near the very bottom. Or ask Google who the owner is. The way pharmaceutical companies buy each other and swap products like Monopoly™ real estate, the ownership of the trademark may have changed without my noticing. It may of changed hands by the time you finished reading this article.
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Almost all of the material on this site is by Jerod Poore and is copyright © 2003, 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011, 2012, 2013, 2014, 2015, and 2016 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 something along the lines of following disclaimer, I’m usually cool with it.
All rights reserved. No warranty is expressed or implied in this information. Consult one or more doctors and/or 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. If you still have questions about a medication or condition that were not answered on any of the pages you read, please ask them on Crazy Talk: the Crazymeds Forum.
The information on Crazymeds pertains to and is intended for adults. While some information about children and adolescents is occasionally presented (e.g. US FDA approvals), pediatric-specific data such as dosages, side effects, off-label applications, etc. are rarely included in the articles on drugs or discussed on the forum. If you are looking for information regarding meds for children you’ll have to go somewhere else. Plus we are big pottymouths and talk about S-E-X a lot.
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Nobody on this site is a doctor, a therapist, or a pharmacist. We don’t portray them either here or on TV. Only doctors can diagnose and treat an illness. While it’s not as bad as it used to be, some doctors still 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 medication1. Self-prescribing is as dangerous as buying meds from fraudulent online pharmacies that promise you medications without prescriptions.
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1 While there are plenty of books to help you with hypochondria, for some reason there’s not much in the way of websites. Then again, staying off of the Internet is a large part of curing/managing the disorder.
2 Remember kids, Microsloth operating systems are like TOS Star Trek movies with in that every other one sucks way, way more. With TOS Star Trek movies you don’t want to bother watching the odd-numbered ones. With Microsloth OS you don’t want to buy and install the even-numbered ones. Anyone who remembers ME and Vista knows what I mean.
3 Have I mentioned how open source operating systems for commercial applications is one of the dumbest ideas in the history of dumb ideas?* I don’t even need my big-ass rant any more. Heartbleed has made my case for me. And that’s just the one that got all the media attention. The very nature of an open source operating system makes security as much of an illusion as anonymity on teh Intergoogles. Before you flip out too much: the domain Crazymeds is hosted on uses a version of SSL that is not affected by the Heartbleed bug. That’s one of the many reasons why I pay a lot of money and keep this site on Lunarpages.
* Yes, I know I’m using open source browsers. I also test the site using the now-defunct IE and Safari browsers. Their popularity - and superiority - killed IE and Safari, so that’s why I rely on the open source browsers. It’s like brand vs. generic meds. Sometimes the generic is better than the brand.
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