We are reposting our People’s Pharmacy Alert from October 3, 2012 because of The New York Times article about “An Increase in Scrutiny for Generics.”
On October 3, 2012, the Food and Drug Administration announced that it was asking Teva Pharmaceuticals USA, Inc., to remove its generic version of Wellbutrin XL 300 from the market. The generic formulation, Budeprion XL 300, was deemed “not therapeutically equivalent to the reference listed drug (RLD), Wellbutrin XL 300 mg.”
This is a huge victory for patients! Their heartbreaking stories about side effects and therapeutic failures linked to Budeprion XL 300 were finally heard. They should feel vindicated. We have never given up advocating for people who contacted us over the last five years complaining about problems with the Teva generic antidepressant. Here is what the FDA announced:
“New FDA-sponsored research shows that the Impax/Teva product fails to demonstrate bioequivalence to the RLD and therefore may not produce the same therapeutic benefits for some patients. We encourage you to share this new drug information with members, health care professionals and patients.”
“FDA 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.”
This is huge! Teva is the largest generic drug maker in the world. In 2006, the FDA approved its generic version, Budeprion XL 300, as a substitute for Wellbutrin XL 300. Not long afterwards, we started receiving complaints about this formulation. Below are just a few of the hundreds of messages we received here at The People’s Pharmacy.

“I just had a nightmare experience switching from brand name Wellbutrin XL 300 mg to the generic Budeprion XL 300 mg, both extended-release. I have no history of ‘suicidality,’ but after switching to the generic, I went into a week of steadily rising panic. Then I hit rock bottom. I wanted to die.
“I made it through the worst of it, called a suicide hotline and didn’t take any more Budeprion. The next day I felt much better and today I’m back to my normal self.
“I just saw my psychiatrist who said my reaction was almost certainly from a toxic dose of bupropion building up in my body. He says many of the generics are not absorbed or metabolized at the same rate as the brand name drugs, so you can get unpredictable effects. This one nearly killed me.”

+++++++++++++++++
“I have been taking Budeprion XL 300 mg for 3 months instead of Wellbutrin XL 300 mg. I find that I am easily upset and cry very easily. Sometimes I feel aggressive. I also have short stabbing pains in my head.
“Taking the brand name drug (Wellbutrin) helped me feel the best I have felt in 20 years–not depressed and able to enjoy being with my family and friends.”

+++++++++++++++++
“I have been taking Wellbutrin XL with a very good result for months. Yesterday I took for the first time the generic formula, Budeprion XL, and experienced anxiety attacks and cried all day. I will never take it again.”
Denise
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“I have been successfully taking Wellbutrin XL for at least 5 years. As my insurance was changed, I was forced to switch to Budeprion XL since the name brand was cost prohibitive. Due to a sudden death of a close friend and other mitigating factors, I thought that my symptoms you described were part of a major depressive episode. While I did experience a major depressive episode, after a time the major issues of the depression had subsided, but I was still feeling not quite right.
“I nearly leapt out of my chair when I read your article about the symptoms others were describing: migraines of prolonged duration and intensity (my Topamax was increased to help with this, something I dislike because Topamax in itself makes me feel loopy), sleep disturbances (I sleep for 4 hours, am awake for 2 or 3, then finally am able to return to sleep with weird dreams), night sweats (I thought I was hitting early menopause at 39), rapid weight gain (compulsive eating and not being able to stop), low energy (sleep difficulties I thought were the problem; caffeine intake tripled), and abrupt and painful changes in my menstrual cycle (again thought early menopause).
“Thus, I will have to find a way to make Wellbutrin cost effective (lowering dosage on Topamax will probably help). Thank you for getting the word out.”

Beth
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“Several months ago I switched over to generic Wellbutrin. Within two weeks I experienced the worst case of depression that I can remember. I had the most severe suicidal thoughts ever.
“I had experienced suicidal thoughts before but this time I actually wrote a letter to my therapist and sent it to an email account that would not be found until after the fact. Fortunately, I called him about 30 minutes later and he reminded me of a story we had talked about in the paper a few weeks earlier about another person who had gotten extremely depressed after switching to the generic.
“I immediately called my pharmacist and got a refill of the regular Wellbutrin. Within a few days I was fine. This ordeal was incredibly frightening.”

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Other readers have reported side effects with the generic bupropion (Budeprion XL 300) that they did not experience while taking Wellbutrin XL 300. Some complained of headaches and nausea, while others noted anxiety and insomnia.
These are side effects that might be expected if a person got a high dose of bupropion. We asked ConsumerLab.com, an independent testing organization, to analyze the pills. Laboratory tests revealed that “the generic product released drug at a very different rate than the original Wellbutrin XL.”
For years the FDA told us that any complaints were basically psychosomatic. That is, people were imagining that Budeprion XL 300 was not working the same as the brand name Wellbutrin XL 300. And their insurance companies were thrilled. Instead of having to pay for the brand name, the insurers could insist that Budeprion XL 300 was “identical” to the brand name.
Well, we now know that the FDA was wrong to have approved Budeprion XL 300 in the first place and insurance companies were wrong when they insisted that patients had to take the generic substitute or pay out of pocket for the brand name.
The FDA is now requiring other manufacturers of long-acting generic formulations of Wellbutrin XL 300 (bupropion) to conduct their own bioequivalence trials. Here is what the FDA has required:
“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 asked these companies to submit the data from those studies no later than March 2013.”
In the meantime, patients are kind of on their own with generic bupropion. Other generic formulations may work just fine, but we won’t know until after March, 2013.
What lessons are we to draw from this incredible boondoggle?
First, the FDA is not infallible. Just because the agency says all generic drugs are “identical” to their brand name counterparts does NOT make it so. The Budeprion XL 300 story proves that. The FDA deserves kudos for recognizing that this problem needed to be addressed and for carrying out its own tests of bioequivalence. Here is how the FDA explains its study.
Second, what other drugs might be problematic? The People’s Pharmacy has received a great many other complaints about generic formulations. Two that come to mind instantly are generic forms of the beta blocker Toprol XL (metoprolol) and the anti-seizure medicine Keppra (levetiracetam). If the FDA conducted its own tests on these generics the way it did for Budeprion XL 300, we wonder what the agency would find.
Third, just because your pharmacist or insurance company says that all generic drugs are fine and dandy does NOT make it so! If you are experiencing problems just cite the Budeprion XL 300 example and ask them to reconsider their dogmatic stance.
If you would like to learn the entire inside story behind this incredible saga you may want to read our chapter titled “Generic Drug Screwups” in our book, Top Screwups Doctors Make and How to Avoid Them. You will learn much more about the FDA’s ability to approve and monitor generic drugs and how to protect yourself from generic drug problems.
Thanks for taking time to consider what we think is an important health news story.
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  1. KC
    Reply

    Be very careful when noticing pill color changes. I noticed this too a few months ago, and thought it was just a new color of the same pill (since it had happened before, same as you, when they switched manufacturers or something.) However, my doctor had written a prescription for 150 mg regular Wellbutrin 3x day (which I got generic as bupropion.) (The pharmacy told me “we don’t have those pills in that mg, so we’ll give you 2 75g pills to take 3x day instead and verified the change with my doctor and I. No problem. Refilled the same following month, no problem. Called in refill to doctors office third month and prescription was written the original way.
    Pharmacist again realized they did not carry that mg of those pills and called doctor to verify change to SR (apparently because regular Wellbutrin does not come in 150 mg tablets, this time they assumed he meant SR and called to verify change.) However, nobody told me of the change to SR, or that they were 150mg tablets, and I thought it was the same stuff I’d been taking, only a different color. (They also left 3x day on the bottle, although SR tablets should be 2x day.) So I continued taking 2 pills 3x day (which I thought were 75mg regular pills in a fancy new color, but were actually 150mg SR pills.
    If I head read the label more closely I may have noticed the 1 pill part, but the SR was hard to notice, and it did still say 3x day. Me being naive as to the change and pharmacy errors, as well as a little ADD, I took them for almost 2 weeks this way without realizing it, and landed myself in the hospital for 3 days, plus I take Adderal for the ADD which probably didn’t help the 900mg/ day Bupropion SR accidental overdose either.)
    Add in to the story a bunch of doctors ignorant to seizures, and a transcriber who entered my medical history and symptoms/ story wrong into my records so that among other things, a neurologist even overlooked the partial-conscious seizure symptoms, and I was almost involuntarily committed to a psych ward within hours of arriving at the emergency room.
    Fortunately, I noticed one of the pharmacy errors on the label the next day, and they retracted the IVC. Thank God! They also almost gave me Haldol, even though my QTc was prolonged. Thank God some doctor noticed that too and didn’t give it to me! Anyway, BEWARE of any pill color changes, and read your labels CLOSELY every time!

  2. CG
    Reply

    I had been on bupropion hcl xl 300mg for years. I had several stresses going on in my life and my dr suggested I add the 150mg as well. It helped tremendously. Fast forward a few years later, we moved from FL to CA. Even though I was using the 90 day mail order from United Healthcare (?Medco? Optum RX?) I had a refill left on the 30 day 150mg, so I had it filled at Ralph’s Pharmacy. The pills were noticeably different – yellow in color and oval, rather than white and round. And the pills in the bottle had a horrible smell to it that the others did not have. The mfr name on the bottle was Global Pharmacy.
    Well, the pills from Global gave me severe stomach cramps, along with mucus and a small amount of blood in my stool. I freaked out, but didn’t initially connect that I had started this other brand of bupropion. I really felt embarrassed about it and did not want to go to a dr. But then I made the connection that I had not been feeling well for the same amount of time that I took the Global pills, so I stopped, and the pain went away.
    Now, my mail order pharmacy has decided the generic bupropion is a higher tier generic, and the pries have skyrocketed. I discovered that Costco was half the price of what the mail order company wanted, and so I went with them. I made sure none of the pills were Global, and they told me they were stocking Anchen.
    After my last dr visit, and prescription “refill,” I discover that my local Costco said they are having issues with getting those meds, and were waiting on a shipment, with no delivery date in sight. I panicked, called every pharmacy I could think of (even Walmart) and they were still so much more expensive than Costco – and the other local Costcos had the same problem as mine. I then decided to try the Costco online pharmacy, and they had everything in stock, and for the same price as my local Costco. Yay!
    Except that when I got the package (which took forever), it was the Anchen brand 300 and the Global brand 150! Aaarrggh! I called them & told them I couldn’t take the Global brand, and they said they had no control over which brand was stocked. (And I honestly don’t remember if I asked them a brand name when I found out they had them in stock.) I told them the pills were useless to me, and I wasn’t’ going to go through the cramps and the blood in my stools again. The pharmacist on the phone must have panicked when he heard that, and said he would send out a return mailer so I could send back the 3 unopened bottles of the Global brand, and they would credit our card and keep the prescription on file until I have them transfer it to another pharmacy.
    Well, I’m still waiting for that mailer, and I”m now at the point where I only have the 300’s to take. I tried taking one of the 150’s yesterday that I still had left from the Ralph’s pharmacy, but I had the same intense pain as before.
    For anyone else taking the Global xl 150’s, are they still the yellow pills? Is there any chance that the pills in the bottles Costco sent me has changed? There is no indication on the paperwork what size/color/look the pills have, so unless I open one of the sealed bottles, I can’t tell.

  3. adhdori
    Reply

    I have had severe problems when switching between brands of generic Wellbutrin SR (I realize this thread is about the XL version, but this seemed relevant). When my pharmacy filled my prescription this last time and the pills were noticeably different (same size and shape, but the color had changed to purple), I was really concerned-thought they gave me the wrong dose. Looked at the label and compared it to the previous one and sure enough-they had switched manufacturers of the generic buproprion without warning me! I (stupidly) decided to give it a try anyway. It was a disaster. I gave it at least two weeks and the horrible side-effects still did not diminish. Decided not to take it one day and the worst symptoms-the extreme nausea and headache-were not there at all! Took a pill the next day and there it was again! I am convinced it was the generic switch that caused it (took long enough to convince me, huh?) And I am in the process of having my pharmacist acquire the previous version. By the way, he said there shouldn’t be a problem because it is the “exact same thing.” Unbelievable!

  4. rlh
    Reply

    I have been taking the 150 xl Wellbutrin and keep trying to switch to generic. I have experienced great difficulty with the generic. Mine also has an A 101 on small, fat white tablet. It is simply not the same as the brand regardless of what we are told. I firmly believe that the delivery issues that exist with generic Wellbutrin 300 are just as present in the 150’s. However, the brand of this product costs around $350 a month here and that’s just no doable for most people. But the FDA moves at a glacial speed, so not certain what we can expect or how to assist the efforts.

  5. cf
    Reply

    Does anyone know the story of the 150mg XL generics? I started taking the Teva-made version (with “A 101″ stamped on it) in fall 2010. A year later I refilled my prescription and there was ~30 days worth of the Teva and ~60 of a thicker pill and that one was the Activiss. I had a TERRIBLE couple of months. A couple of vicious migraines, and incredible tiredness. One time I was falling asleep while driving on the interstate and I got off and was going to go into the McDonalds to get some caffeinated something, but instead I just put my head back and slept for 2 hours. And I gained about 15 pounds.
    I finally put things together when I refilled my script. I always keep a small stash – 3-4 days worth — of each of my meds in my purse just in case I am somewhere unusual when it is time to take them, and each time I get a refill I “rotate stock”. When I went in to my purse I remembered that the pills had changed when I saw the old smaller pills. I put them into rotation, and I IMMEDIATELY felt hugely better — it was like when I first started taking them. The weight immediately disappeared, too. With some trepidation I started taking the new refill of Activiss pills, and continued to feel great.
    I did some research, and found all of this documentation of how the extended-release mechanisms on generics are NOT part of the copy of the real drug, and don’t necessarily work the same, and because of how this particular drug functions it makes a huge difference. I also found lots of suspicion over the Teva (although now I think that this was about the 300mg dose, and the whole point is that it’s different.)
    So I sat down with my pharmacist, and we went over the options. Teva seems suspicious, the Activiss looked like it had a quality control problem (one batch worked well, one did not.) The Watson brand had a good reputation, so we settled on taking that, and all was good.
    Until Dec 15, when I refilled. I didn’t even notice until I got home that the pills had the A 101 stamped on them (which drugs.com still says is Teva, but the manufacturer is now listed as “PAR”.) And over the last three months I’ve noticed my mood is deteriorating… Crying jags, gained gobs of weight, headaches.
    I went in for my refill on Saturday, and the pharmacist came out and explained that the reason I had gotten the Teva the last time was that all of the other generic manufacturers had discontinued their products, and there wasn’t even any old stock to snag. He suggested the SR product, which spreads the medicine over 12 hours, but there is no 75mg version of the SR, so that would mean doubling the dose. Which I’m not crazy about when I had a brand that worked well at 150mg/day.
    So what the heck happened with the FDA review that was talked about in the Dec 2012 news reports? I found this from October:
    http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm322161.htm

    Update: Bupropion Hydrochloride Extended-Release 300 mg Bioequivalence Studies
    FDA’s update on this issue is an activity that is funded under FDA’s user fee program in the Center for Drug Evaluation and Research (CDER). Some FDA activities that do not rely on annual appropriations are continuing during the government shutdown.
    [10-10-2013] FDA is providing an update on its request for studies to assess the bioequivalence of marketed bupropion hydrochloride (HCl) extended-release (ER) 300 mg tablets. We have completed our review of the studies from all four manufacturers of bupropion HCl ER 300 mg products currently on the market: Actavis, Inc.,* Mylan Inc., Par Pharmaceutical (formerly Anchen Pharmaceuticals), and Watson.*
    Data submitted by Actavis, Inc., Mylan Inc., and Par Pharmaceutical confirmed that their generic bupropion HCl ER 300 mg tablet products are therapeutically equivalent to the reference-listed drug, Wellbutrin XL 300 mg. Patients can have confidence that these generics will have the same clinical effect and safety as the brand name drug.
    Based on data submitted by Watson, FDA has determined that that company’s generic bupropion HCl ER 300 mg tablet product is not therapeutically equivalent to Wellbutrin XL 300 mg. Watson has agreed to voluntarily withdraw this product from the distribution chain. Also, FDA has changed the Therapeutic Equivalence Code for the Watson product from AB (therapeutically equivalent) to BX (data are insufficient to determine therapeutic equivalence) in the Orange Book. FDA does not anticipate a drug shortage.
    We recommend that patients taking the Watson product continue taking their medication and contact their health care professional or pharmacist to address any concerns.
    *Note that Actavis and Watson recently merged.

    So, what the heck? Did the FDA manage to drive everybody but Par/Teva out of the business of the 150mg tabs? This is all talking about the 300mg, and those articles make a big deal about the 150mg being tested and passing.
    I am certainly willing to allow for the possibility that this is “all in my head” (ok, the migraines are DEFINITELY in my head!) but it looks to me like the FDA has forced off the generic that works and left only one that doesn’t!!! The reason that I’m on wellbutrin rather than another anti-depressant is that I have thyroid problems, and my endocrinologist tells me that this particular drug works particularly well against the particular sort of depression that is a symptom of hypothyroid.
    So does anybody have any news about what the drug companies and the FDA are doing/planning?
    I wish there were something like a “brand-name generic” where after a drug goes out of patent there would be multiple manufacturers who would do some basic studies to make sure that their drugs are equivalent and have a known reputation for quality control. I’d be willing to pay like double the current generic price for a name brand I trust, but 10x? Yikes!

  6. DS
    Reply

    For those looking for brand name Wellbutrin, try googling it now. Valeant has set up a program where you can get it for $50 a month paying cash. This is called Direct Success Pharmacy. Those who have used the brand name in the past say these pills are identical. The website appears to be the official Wellbutrin website. Has the owner of the forumla realized that they had better do something about the prices now that insurance companies won’t cover it and force everyone on to generics? It appears so. I’m not thrilled about the $50 a month, the reason I pay health insurance premiums is to have my medication covered. But I’m just glad to have it available for less than the $300+ my pharmacy quoted me. I started taking generic from Global Pharm, no positive effect, I just feel tired. I hope the brand name will help me. I have just submitted the form to my doctor and am waiting to see what happens.

  7. wr
    Reply

    I just found out that TEVA was FINALLY (300 wellbutrin xl) off the market!!! I was almost suicidal on those meds. I wrote a letter to the FDA back in 2010 and had to convince many doctors that the Teva brand of wellbutrin xl was dangerous. I tried many times to take the Wellbutrin Brand but my insurance stopped covering it- so I switched to 300 SR. I will stay on the SR because I do not trust any generics now…

  8. R R
    Reply

    Count me as someone who moved from 2x a day 150mg (I think PAR) to Watson 300 XL. Didn’t do nearly as well as the 2X a day for almost two months. Then, they pull the Watson (round) pills and am given Actavis. I actually start doing even worse than I was on the Watson and definitely worse than the 2X PAR. My family even was commenting on the change for the worse. I just took advantage of the Valeant offer for the real stuff at $50.00 per month. It’s about 15X more expensive even at $50 than $10 for a 90 day generic supply but I’m already noticing a HUGE difference. I’m hoping it continues and I get back to how I felt on the 2X a day.
    I think the FDA’s guidelines for testing are total crap. Their bioequivalence methodology is whacked. They allow for up to a 20% difference in drug action and are only requiring the companies meet a 90% equivalent for the main drug and not for the other metabolites.
    I have taken all sorts of generics of antibiotics, pain meds, etc. and had no problems but there is STILL something wrong here with the Wellbutrin generics.

  9. Gemeniguy
    Reply

    Pulling TEVA Budeprion XL from the marketplace was total political nonsense. The only medications which ever worked for me were Wellbutrin XL and Budeprion XL. ANCHEN Buproprion XL, ACTAVIS Buproprion XL and TEVA Budeprion SR worked great, if great means loss of libido and/or depression.
    Unless I’m willing to live a miserable life, I have no choice but to use expensive Wellbutrin XL when I could be using inexpensive Budeprion XL. If the FDA is willing to pull Budeprion XL from the marketplace, then it should pull virtually ever other generic drug there is as there is probably at least one person or more for which a certain generic drug doesn’t work.
    But I have a solution to this and I know it’s very complicated. But here is anyway- If a certain generic drug manufacturer doesn’t work for you, use another.

  10. Susan
    Reply

    I have just discovered that my generic Wellbutrin 300XL has not been dissolving. Yesterday I found 2 totally undissolved pills in my stool which leads me to believe they were the pills I had taken the last 2 days. I have tried, with great results, name brand Wellbutrin but stopped when my insurance company refused to pay for it. I’m very concerned with other symptoms as well and wondered if anyone else has had the issue with undissolved pills. Now I’m wondering how many other pills passed the same way without me noticing it?

  11. michelle
    Reply

    I have also felt the same way. I’m taking 300mg of bupropion. Ive been on it for i guess2months. I was taking it with another med. (Can’t remember the name) but it was samples. When I went to get it filled it was 45.00 sooo….. I didn’t get it. Anyway I’m feeling just like you did an I’m coming off of it. Glad to know I’m not going crazy!

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