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Patients Vindicated! Generic Wellbutrin Withdrawn

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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."

+++++++++++++++++++++

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.

If you find this kind of People's Pharmacy Health Alert worthwhile, you may want to share it with a friend. At the top of this page you will see a box next to the title with icons to email this to a friend or acquaintance or post to Facebook or Twitter. While you are at it, you may want to let those you care about know that they can sign up for The People's Pharmacy electronic newsletters and health alerts by visiting our site and putting their email address in the upper right hand box that says "Free email newsletter." Staying informed on breaking health news stories is the best way to protect yourself and those you care about.

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I am so glad to read this! I tried the generic of Welbutrin XL (BuPROPion) and hit rock bottom as well. I drove around the county looking for spots to commit suicide, cried all the time, withdrew, even "ran away from home" to my daughter's house while they were out to eat- worrying my other kids and husband. I thought I had really lost it.

I switched to another anti-depressant and am 100 times better, but I thought my next step was a psych ward or a grave.

THANK YOU for all the hard work you do to make the pharmaceutical world a safer place!

Huge win for us! A crack in the armor! I now have neuropathy because of one of three generic Keppra (levetiracetam) formulations. Two, Lupin and Boca, caused severe burning and itching. The third, Camber , seemed to be o.k., causing only heating and bumps on skin, until I came down with neuropathy.


Linda

Has anyone experienced similiar doubts regarding Bupropion SR 150MG?

Finally!!! I actually went through a suicide attempt from this medicine. I knew it was this drug and had to unsuccessfully fight insurance to switch to Wellbutrin brand name- which had worked well for me. I now pay quite a bit of $$ monthly to stay on the brand name. My friend's husband killed himself while taking this bupropion.

Since budeprion is withdrawn, does this mean the generic buproprion is ok to take?

My healthcare plan insists on using generics to lower costs under the mistaken belief they are equivalent. Unfortunately in this case is took 6 YEARS! to prove this assumption was false.

I had a similar problem with a Teva generic statin -- GI problems that I did not have with the specific. I told the pharmacy to fill with a generic made by the same company that made the specific -- no problems.

I have felt really down, irritable, unable to focus, and just couldn't figure out what was wrong. I felt all the symptoms of depression but I was taking my medication (bupropion) and trusted that there must be something else wrong. I feel like I have been handed a life-line.

It's developments like these that led me to seek ways to address anxiety and depression issues with natural remedies and lifestyle changes. It's been 7 years since I quit Wellbutrin and its kin and set out to find another way. I finally discovered, (and inspiration from The People's Pharmacy has been a played a big role) that my problems are triggered by intolerance to certain foods (most notably, gluten). Yes, sometimes a medication is the right answer, but always be on your guard against the all-too-easy quick fix especially when it is a powerful drug you are led to believe you can stay on for life. Seek another way! Usually, if you really want change, you have to change what you are doing, and that is difficult. It takes persistence, discipline and some careful listening and objectivity about your own condition, but the results are worth it and then you needn't be afraid of the next FDA bulletin.

Does Budeprion SL have the same problem and are they recalling it?

Is the solution to go back to Wellbutrin (name brand) or switch to another Antidepressant?

Which Antidepressant is most similar to Wellbutrin that is out in generic?
Thanks for your efforts.

Thanks for the alert as my wife takes the generic but 150 mg versus the 300 mg cited. I suggest you add to your announcement only relates to 300 mg users and not 150 mg. However, this creates the question as why only 300mg and not 150mg?

KLR

Just to let you know that this was a very helpful article

I have been using the generic form of Wellbutrin XL 300 since it came out and have not had any negative side effects at all. It was a completely uneventful transition. I cannot possibly afford the non-generic original and hope I still have choice in this matter.

Talk about vindication: I'm crowing! In 2007 after our company's insurance switched me to 300XL budeprion from Welbutrin 300, I wrote to the FDA, the People's Pharmacy, and my then current Part D pharmacist and gave my poor reactions to it.

A Teva pharmacy physician eventually called me at home and asked me to provide him with the same information, which I did. It took 5 years, but finally I am gratified that this product was pulled of pharmacy shelves!

What's it for? Antidepressent? Could not tell from the article.

PEOPLE'S PHARMACY RESPONSE:

Wellbutrin (bupropion) is an antidepressant. It is prescribed to treat depression.

There were problems with generic Dilantin quite a few years ago. A friend was taking brand-name Dilantin for non-epileptic seizure control. The company drug plan made him switch to a generic version and he started having problems again. I gave him some information about generic Dilantin problems from People's Pharmacy. He did further research, and with his doctor's help, the drug plan agreed to again pay for the brand-name Dilantin. His seizure problem was again under control. So the non-equivalence of FDA-approved generics is not a recent problem.

Search for Joe and Terry's editorial on "Genric Drug Problem Raises Questions On Quality" which they published on the website in 2004. This highlights the problems with generic Dilantin.

The Metoprolol I took for years was always a tiny oblong white pill.

Then several months ago the prescription was refilled with a small round white pill. I noticed my heart began fluttering and skipping. I notified the pharmacist and she said it could be the different generic version by a different manufacturer. She got me some more of the white oblong ones and I have not had any problems since.

Other generic medications have changed color/shape in the past without noticeable effects.

I told my Doctor about the Metoprolol problem and she said, "That cannot have any effect." When I told her what the pharmacist said, she didn't comment.

So for those of us who have been forced to take this generic medication (five years for me), now that it has been recalled, what is our next step? Will we still be able to get the prescription filled using another supplier? As unreliable as this medication has been, I do not want to discontinue it.

I fear the effects of not being able to get my prescription refilled, and I certainly can't afford the name brand. What should we do now? Thanks in advance for any advice.

PEOPLE'S PHARMACY RESPONSE:

There will still be 4 long-acting generic bupropion formulations on the market. The FDA has required these companies to conduct tests to verify that they are bioequivalent to the brand name Wellbutrin. You should be able to access this drug in generic form at least until March 2013 when the companies will have to submit their test data to the FDA for review.

I too used the 150mg and experienced the suicidal thoughts. I don't think the side effects are for the 300mg alone!

My formulation is from Achen and I still had these terrible side effects. I have never been so glad to get off a medication in my life. I hope the other companies will realize that their products do not conform to the brand name either!

I also used wellbutrin xl's generic. I was on it for a month. I found myself crying at the drop of a hat, and so very down. I talked to my pharmacist, and he said that this reaction has been reported to him before. In turn I emailed my doctor and told him that I had to stop the generic of wellbutrin xl, as too many side affects. Besides being overly sensitive, my feet and hands swelled up so much that I could not find one pair of my shoes that fit..

I also gained 8 pounds of water weight. My doctor told me to double up on my maxide, and in one week I was back down. I have needed to gain weight, but not just water weight.

I cannot use the generic of maxide. We found out three times while I was in the hospital that I gained weight quickly and my emg looked like a mountain range. They had to call in a heart doctor one time as my bp was so high and I had chest pains. I don't know what is in the generic of maxide, and it has caused many problems while being in the hospital, and even bringing in my own maxide from my pharmacy, and they used their pill identification unit, they still would not give me my brand name maxide. It really has posed a problem. Thank you, Fonnie

I am so glad they finally had to admit generic Wellbutrin does not work. I spent years after the death of my daughter trying antidepressants with no luck. Finally I was given Wellbutrin and it was the only one that ever worked for me. My insurance company would not pay for Wellbutrin after the generic came out. It had taken a while for me to realize the reason my depression was back was the switch to the generic brand.

I read The People's Pharmacy every day and that is how I finally realized what the problem was. I wrote my insurance company and pleaded with them to pay for the Wellbutrin but they wouldn't. I also told my doctor it didn't work and asked if he could give me samples but that was not possible either.

I certainly think those of us who have taken it and had adverse or no results should be compensated for the wasted money that we've spent and that's not even considering the mental anguish suffered. Wellbutrin was a huge factor in saving me from suicide and the switch to the generic put me right back into that same downward spiral. I was able to pull myself out of it but I have never gotten back even close to the relief I felt while I was taking the Wellbutrin.

Did you know that generic drug companies are immune from lawsuits? Across the country, dozens of lawsuits against generic pharmaceutical companies are being dismissed because of a Supreme Court decision last year that said the companies did not have control over what their labels said and therefore could not be sued for failing to alert patients about the risks of taking their drugs. Orwellian, Kafkaesque, Brave New World!(http://drugrecallwatch.wordpress.com/2012/03/21/generic-drugs-proving-resistant-to-damage-suits/)

I recently was switched to a different generic brand of Zoloft (Camber) and it was like I wasn’t taking anything at all. Because I believed all the “equivalency of generics” stuff, I just naively had no idea what was happening until I was in full, sudden SSRI withdrawal. Something was missing from the Camber—like the active ingredient. It is ironic that after they finally added the warning to not abruptly stop taking SSRIs that the failure of the generic brand caused me to go into sudden, unexpected total SSRI withdrawal.

It was like I had taken nothing, and when I was finally able to get the brand I had been taking for years, it took about two weeks to become effective. This delayed efficacy again suggests that the active ingredient was missing from the Camber, as if I had been on nothing during the 12 days of the Camber. I want to report this to the FDA but it doesn't seem like their adverse event report form is designed for this kind of generic drug failure.

I was wondering if there is a specific place to report generic drug problems. I guess the FDA doesn't want to draw attention to the problem by having a specific form for that. Also, is there any place to send the Camber to have it analyzed?
I have just recently had that experience of reporting a generic problem to the pharmacist and she responded with a robotic recitation of official FDA mumbo jumbo about equivalency and how I was crazy to suggest otherwise.

Is there a book or web site that has good information on generic drugs, like what the heck are all those fillers in generics anyway? Can we find out what's in the generic?

Also, what about splitting pills that are scored. Is is possible that in some generics the active ingredient isn't suspended consistently throughout the pill and so one half might be an overdose and the other an underdose?

The dr. and pharmacist acknowledged that Levothyroxine is a drug that has a narrow window of efficacy, and they admitted that generic drugs aren't equivalent. But if all generics have the same mgs. of active ingredient why isn't all levox the same? Either the amount of active ingredient isn't the same or the "fillers" are the cause of the differences. I just don't get it.

I also read that generics by law don't actually have to contain the same amount of active ingredient as the orginal brand, as long as it's within a certain percentage. Does the FDA test generics for purity?

PEOPLE'S PHARMACY RESPONSE:

Read all about our investigation into generic drugs in our two books:

Best Choices From The People's Pharmacy and

http://peoplespharmacy.com/best-choices/

Top Screwups Doctors Make and How to Avoid Them

http://www.peoplespharmacy.com/topscrewups/

You will learn how to protect yourself from generic disasters.

I started taking the generic Wellbutrin (bupropion), and after a week or so of taking it, I had such bad indigestion and stomach pain, I was not able to sleep all night long. My stomach was so extended, it hurt to turn over in bed. Wondering if anyone else had such side affects?

Earlier this year another antidepressant went generic - I've been on a low dose of Lexapro for a few years and was feeling great. I was switched to generic (at no savings to me, because they can charge brand name price for a year) and within a few weeks was feeling awful... draggy, tired, "bummed out", no interest in doing the things I had been enjoying just a few weeks before. Not as bad as I felt before going on the med, but certainly not how I had been doing.

I gave it 6 weeks before I went back to my doctor and said the generic wasn't working right. To his credit he acknowledged I was not the only person complaining of this and gave me a new prescription "brand name only". Better within a few days, fully "normal" in a week or two.

A few years back my mom was on a generic blood pressure med and was fine. The pharmacy switched suppliers of the generic... within 30 minutes of taking it she would feel weak and shaky and her BP would plummet. Later in the day her BP would be up. Obviously it was being absorbed at the wrong rate. She had to switch to the brand name, which worked fine but cost her more as the insurance would not cover it.

This is a big issue and deserves more scrutiny from the FDA to ensure generic formulations are truly the bioequivalents of the brand names.

Thank you for this information. I take 50 mg of Zoloft and found that the generic made my stomach feel numb and quite uncomfortable. Zoloft is expensive but worth it to me. Any research on its generic?

When I sent you praise for your work several months ago, I said keep up the good work. Your putting information out there about product problems is helpful to the consumer because they don't have access to this in other media. This is one battle won in a long war against the drug companies who put product movement ahead of good healthcare.

Excellent! This has been a long- standing battle with us consumers and insurance companies. When my insurance finally stubbornly refused to budge on allowing Wellbutrin XL-300 my doctor and I just had to find another combo that worked. I also went through the years to find an understanding pharmacy.

I live in a very small town. The local Wal-Mart would fill my prescription with whatever generic bupropion they had on the shelf that month. When we'd asked them not to do this, they're answer was always "Doesn't makes any difference, they're all the same."

So I switched pharmacies that tried to keep me supplied with at least the same generic and when that didn't work, my doctor wrote the scripts that they HAD to be filled with name brands. Too many switches and I'm visiting one of the local psych hospitals with the Bee Gees singing "Staying Alive" to me!

I had a serious problem with the Camber generic brand of Zoloft. It caused me to go into abrupt total SSRI withdrawal as if I had taken nothing. Since I believed that generics were equivalent, I was not expecting the sudden and extreme withdrawal effects. After finally figuring out what was happening after 10 days, I ordered the brand I had been taking for years and it took 2 weeks for it to become effective; the time it took to reach steady state means I was starting from zero, again suggesting the Camber brand had no active ingredient, or was so effectively different in mechanism or delivery that it amounted to a different drug.

It was very scary.

It was not enough that there were thousands of reports about generic Wellbutrin problems. It takes lawsuits to convince the FDA to change its positions. The FDA waits for citizens to prove drugs are ineffective or dangerous; I thought that was their job. Their passivity on the Wellbutrin XL generic leaves little doubt that the FDA mainly exits to rubber stamp drug company-funded drug trials.

Joe and Terry, I'm a long time fan and I know you walk a fine line, so you will probably edit out that line about the FDA. You are fighting the good fight and I really admire your diplomacy and tact! I know you are as dismayed as I am about these issues.

Generics have always been an issue for me. Prozac, is a good example of strange, dissimilar feelings with generic (for me). Generics, never again. Word to the wise, for all those taking psychotropics and other antidepressants - ALWAYS start with half the recommended dose. Years ago it was standard for introduction. Everyone is different. The therapeutic dose was established by the least/highest effective dose in a group study. Some are very quick to respond, some needed lots more.

It is very hard to establish which one is right for you and a slow introduction to your system is key. Unfortunately 10mg. is special order and the drug companies charge the same $ for 10mg as 20mg. Often they are capsules unlike the once-upon-a-time tablets you could cut in half. The drug companies are hip to making their buck, eh? Generic Xanax (from certain companies) has produced the opposite affect at times for me, so be careful.

My pharmacy said I have a different generic from Teva so I should be fine with the generic (Bupropion HCL XL) which I have been taking. However, that does NOT change the symptoms I have been struggling with, so today I had my Dr. write a prescription for Wellbutrin 300XL. It cost alot, but I will know if there is a difference in the next month or so. I will post the results.

My wife also takes the 150mg, and I have the same question

Thank you so much for helping to get this drug removed. Years ago I was switched by my insurance company from Wellbutrin XL to Budeprion XL and within a short time became suicidal, depressed, and anxious. I couldn't imagine what had caused the change and was pursuing plans to kill myself. When it finally occured to me that I had switched meds I got back on the Wellbutrin (at my own expense) and felt almost immediately better.

For years I've been telling doctors that I won't take Budeprion and I'm sure they all thought I was crazy. Thank you for finally proving that the Budeprion is harmful (or at the very least, not helpful)!

The supreme court ruled that generic drug makers can't be sued because "they produce a product that is substantially the same as the name brand drug, and are required by law, under most circumstances, to use the exact same labels as the name brand manufacturers. Therefore, courts have found that the generic manufacturer cannot be held at fault for failure to warn about dangerous side effects since they are required to use the same label as the name brand manufacturer, and the name brand manufacturer is responsible for the label."

This ruling produces the following catch-22 in such cases as litigation claiming that SSRIs (Zoloft, Paxil,Lexapro) cause birth defects:

The ruling means that only name brand Zoloft users can sue Pfizer for failure to warn about the serious side effects; generic users, on the other hand, cannot sue Pfizer (because they did not take the Pfizer drug) and patients cannot sue the generic manufacturer either, because the generic manufacturer did not control the labeling and courts have shown that they will dismiss these cases.

Due to costs, most insurance companies require that patients use the generic brand to get benefit coverage; therefore, the majority of users of these drugs have no legal remedy if they are harmed due to label's failure to warn of risks. Generic Wellbutrin XL plaintiff's won their case because the argument was that the generic was different from the brand in formulation delivery mechanism.

http://www.nytimes.com/2012/03/21/business/drug-lawsuits-hinge-on-the-detail-of-a-label.html?pagewanted=all

I mentioned these findings to the Psychiatrist I have been seeing. He basically said it was nonsense and that he had many patients on generic Wellb who are doing great. He had me on 300mg. (manuf.by MYLAN) and just added another 150mg. (manuf. by ANCHEN.) 450mg of anything seems huge, especially since my symptoms weren't severe...just "down" and kind of joyless.

I don't know what to do. I can't keep doctor-hopping. Additionally, I have taken 1mg. of clonazepam for years to sleep and I drink wine.....this feels like 'The Valley of the Dolls!" I have read so many negatives about this generic that I don't know who/what to believe!

PEOPLE'S PHARMACY RESPONSE:

The FDA has asked other manufacturers of long-acting generic bupropion to do bioequivalence tests. The FDA is hopeful that the products made by Mylan and Anchen will be fine. We will know for sure after March, 2013.

RE: Bupropion and Levothyroxine.

Was put on Bupropion a few months ago for anxiety but had to deal with horrible side effects, the worse being extreme depression, with crying spells that never let up for days. Thankfully, after a month of misery, was prescribed a different med with positive results. Sure hope generic Bupropion is no longer marketed.

Have also been treated for low thyroid with Levothyroxine for many years. I, too, wonder if generics are equal. Most of the time I feel pretty normal, but there are some months that fatigue just takes over. I feel best when I get a solid 7-8 hours of sleep, but wonder why at times I can hardly get out of bed and need 9-10 hours of sleep. Could this be the result of generic manufacturing problems also?

The one drug that both my pharmacist and my doc admit is different from brand to brand is levothyroxine. This is because it has "a narrow window of efficacy." Logically, this casts doubt on the whole "generics are equivalent" dogma. But they somehow don't see it that way.

I find that smart people like doctors are just as blinded by operating assumptions as mere mortals. My acupuncturist put it this was: MDs are taught to be superior. With regards to generics,I think the term "equivalence" is being used in practice to mean "similar." By the way, acupuncture really works for depression and anxiety, especially with a very good acupuncturist.

Great link showing that generic drug companies cannot be sued from because they use the exact same labels. The case with Budeprion XL 300 mg isn't about labeling. It is about using it's own time release mechanisms in a product that doesn't work.

My daughter had a seizure taking this medication. I realize that Budeprion XL has a side effect of seizures, however, she was put at a greater risk for having one if the medication was delivered too quickly. In my opinion, the manufacturer and the FDA should be held accountable for this unsafe drug. The FDA shouldn't have allowed this medication to go generic when the time release mechanism was still under patent and the company that was making the generic should have conducted studies with the 300 mg dose to make sure that the medication was being released at the same rate as the original.

All generic forms of this med should be removed until they can PROVE that their delivery system is equal to the original Wellbutrin XL 300 mg. I take this medication, too and I'm switching back to 100 mg dosing of Buprobion three times a day. Why would the FDA allow the public to continue to take another generic form of this medication when they have found this huge error in this manufacturer? THE TIME RELEASE MECHANISM IS NOT IDENTICAL TO THE REAL DRUG THEREFORE IT'S NOT THE SAME MEDICATION.

I have been on Wellbutrin 300XL for many years now. It helped tremendously. Since the Insurance Companies decided that the name brands were too expensive, I have been on Bupropion HCL 300XL. I know that my generic has been changed several times. The generic name on the bottle is Actavis. Now, I am feeling very anxious and very short tempered. Where do I go from here?

I am so glad to see this news!! Over the years I have experienced differences with several Brand name vs generics drugs, but was always told by the condescending pharmacist or doctor that "that's impossible" and I must be imagining it. Just recently I got an RX for Sonata, and mentioned to the PA that I didn't think the generic worked as well as the brand name and he agreed that can happen, but then failed to write 'no substitution' on the Rx. I decided I would try filling it at a different pharmacy hoping they might use a different manufacturer, but these were even worse, they do not work at all! With sleeping pills you KNOW if they work or not and these are basically expensive sugar pills.

I just got the bottle to see who makes it and its Teva!
Please let me know the proper procedure to report this pseudo drug and the company that makes it.

I am delighted that the FDA finally came around and listened to these postings and the work of organizations such as The People's Pharmacy. I sincerely believe that the Teva budeprion 150 xl has the same type problems.

I have tried a number of times, with my physician's approval and instruction, to switch from Wellbutrin 150 xl to generic for pricing/insurance issues. Each time it has been an eventual abysmal failure. It has been hard to notice at first because for me the symptoms for which I began the drug in the first place crawled back in slowly and insidiously. Then I realized I had gained weight with no explanation for same, slept poorly, was becoming blue and down, was very irritable and had intolerable headaches much of the time. Almost as soon as I went back to Wellbutrin, these things resolved and I felt normal again.

We must express these problems with generics besides the one now being recalled. If others are experiencing them, we should let it be known. This was a true victory for folks simply trying to stay well and save money at the same time. We also need a generic manufacturer to step in who can achieve a good generic drug with the same delivery system as the Wellbutrin product.

I have been on BuProPion XL 300mg for almost 4 mo. It was ordered for chronic fatigue, along with Nuvigil. I began to notice i was depressed and sometimes anxious. I did not have these sx before. I was trying to stay on since it might help with the fatigue. Now I will call my doctor and find out how to come off this drug. I am glad to have found this site.

This drug has been wonderful for me.. Just wondering if I can still get the real wellbutrin or are they removing both..

PEOPLE'S PHARMACY RESPONSE: Brand name Wellbutrin and four generic bupropion products remain on the market. Only Teva has been asked to remove its generic, Budeprion.

I am so glad to find this article about generic brands and especially about the withdrawal of generic brand of Bupropion HCL 300mg XL.

I went to my psychiatrist because my generic bran medication has never realy helped me and I had just lost my husband and was feeling very depressed and needed help. I have had many psychiatrists and when I tell them that the generic medication doesn't help with my depression all they do is raise my doses. Even at a higher dose I still feel "flat" and very depressed. They all say that the generic brand is the same as the name brand. I just get this look like "whats wrong with you women"?.

Why won't the believe that it is not the same as the name brand. I am now sure that others are having the same experience with the generic antidepressants after reading all the people saying the same thing, generic is not the same as the name brand. What can we do about this People's Pharmacy??? Do the psychiatrists really believe that the generics are the same as the name brands??

Wow! what a trip this is. I will print all of this article and show it to my psychiatrist, hopefully she will read it and know that I am the only one saying this.

It appears that people have been taking several different versions of generic Wellbutrin with troublesome side effects for all of them. My concern is that only one generic will be stopped and not all versions. I was on Bupropion HCL SR 150 for anxiety but it put me in the worst depression.

I thought TEVA had took the Welbutrin XL 150 off the market to because the 150 made me almost kill myself and I'm glad I knew it was the drug change from name brand to TEVA that made me feel this way!

So please be careful if you are on this drug by TEVA! It's not you but the drug by TEVA! How can they legally get away with doing this to us as a people! What if someone kills themselves?

This is great news. Thanks to the People's Pharmacy for sticking with this issue. Very interesting, because Express Scripts has just sent out letters to people taking brand name Wellbutrin XL 300 to let them know that it will no longer be covered.

I just spoke to a pharmacist at Express Scripts--his response was that the 5-6 other generic versions might be just fine...

PEOPLE'S PHARMACY RESPONSE:

Thanks Anonymous E. The emphasis should be on the "MIGHT BE just fine." We don't know until the actual tests are conducted and submitted to the FDA in March, 2013.

Hi.
What about buPROPion HCL XL 150mg. Mfg GLOBAL PHARM. Generic for Wellbutrin XL 150mg. I have not seen this one addressed here. I am doing fine on it. (I'm also taking citalipram 20mg, which I'm fine with also.)
Is it one that will be tested also?

Thank you.

I've been taking the brand name Webutrin XL 300mg for many years now. I just recently ran out of my last bottle of the brand name. When I went to refill it shortly before I was completely out, I found out my insurance company will no longer cover the brand name even with a prior authorization from the doctor.

I tried the generic version in the past and found that it did not work. I tried it at least 3 different times with the same results. I figured I'd give the generic another shot, given the circumstances. I decided to try it before I was completely out of the brand name so I could do some direct comparisons.

I took the generic for 3 days. It felt like I hadn't taken anything except for the fact that I felt nautious and dizzy for those 3 days. I decided to switch back to the brand name on the 4th day and noticed a huge difference immediately. Everything seemed to be working properly. The nausea & dizziness were gone.

I took the generic the next day just to make sure I wasn't just sick those 1st 3 days. Once again, it was like night and day compared to the brand name. The nausea & dizziness came back and along with it, the symptoms of my depression.

For the following 2 days, I took my last 2 brand name pills & found everything back to normal. I am absolutely 100% convinced that the generic does not work. The version I tried was distributed by Anchem. I have not tried any other versions recently (not sure who manufactured the ones I tried years ago).

I've read numerous posts from patients describing the same kinds of problems with the generic, but it seems to be all of the manufacturers of the generic. When I read the FDA's statement about pulling one manufacturer's version, Budeprion, completely off the market because they found it to be ineffective, I felt as if what I have been experiencing may not be a fluke. In addition to that, they ordered that the other 4 manufacturers of the generic conduct studies to prove that their drug is in fact the bioequivelent to the brand name. What I do not understand is why they didn't pull those 4 manufacturer's versions off the market until they could be proven to be as effective? After all, they would not be demanding for those studies to be submitted if they were sure that the drugs were as effective. Also, why isn't the FDA conducting their own independent study of each of the 4 manufacturer's versions of this drug?

This all seems crazy to me. Isn't the FDA supposed to be protecting us?! I am very frustrated because I cannot afford to pay for the brand name with no insurance coverage. I'd like to know what options I have. I can tell you after being completely off the medication for almost a month now, I am very concerned. My depression seems to be worse than it has ever been. I am even starting to have suicidal thoughts, which is very new to me.

I'm so desperate that I'm even considering trying to find a Canadian pharmacy to get the brand name at a price I can afford. This is certainly not what I want to do, but what other choices do I have?

I had such a battle with depression taking Bupropion 300 mg. that I took money out of savings and for the past three months I have been purchasing Brand name Wellbrutrin 300XL. It has made such a difference I can"t even describe. I don't know how long I can continue at $230.00 a month, but I feel so good that I can't imagine going back on the useless kind.

What is the FDA doing about this? I did not take the TEVA brand but the others don't work either. It is so unfair that we do not have a voice in this based on all the testimonials.... I also was looking for any discounts or coupons available to help me with the brand name purchases, but since I have insurance they do not allow me the benefits of being under-insured. This is really a health crisis for all of us that struggle with the generics.

The best bupropion I was prescribed was Wellbutrin XL 300. My new insurance company said no more, so I was switched to twice daily bupropion generic SR 150's. Sometimes I got Mylan, sometimes Teva, and I was OK with both, although the effects were not as "level" as with the Wellbutrin XR.

Now there is a new player, Wockhardt. In my opinion this is THE WORSE bupropion generic I have ever taken, and I have taken bupropion for 15 years, so I know what to expect. I canonly hope the new FDA procedures will uncover the problem with this brand. I have my doubts, because the FDA relies heavily on reports from the manufacturer. In fairness to Wockhardt, there is every possibility that what was dispensed is a counterfeit drug, even though I purchased it from a large U.S. chain pharmacy.

"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."

Have the results of these studies been released and if so where can I find them? I have been taking Bupropion XL 300 for years. When I asked the pharmacist about it after your alert he said that mine was from a different manufacturer.

People's Pharmacy response: We are working on getting answers to these questions.

Yes, exactly, depressive, hopeless thoughts which led to actions - but, my friend called police and emts. Very hard time. I ended up paying a % of brand name after a lot of paperwork to and from insurance doctors etc.

I am now off of Wellbutrin, but that whole episode haunts me to this day. (I have no problems with taking generic forms of other meds., but - the bupropion terrible and obvious).

Hello-I have been following this story ever since I had the light bulb moment as to why my generic Wellbutrin has not been working for the last couple of years…apparent extended release dissolution problems.

My mail order pharmacy, CIGNA Tel-Drug sells Global brand, an oval yellow tablet with a 681 on it. I noticed a huge difference in efficacy from the retail CVS generic brand Watson, which I now know had been the authorized generic for Wellbutrin. The Watson brand worked well.

I spoke with CIGNA Tel-Drug who stated that their contract is with Global; they did not carry Watson. However, the pharmacist was willing to submit my concern about the efficacy problem with Global to Cigna.

Upon researching this article (http://www.bizjournals.com/philadelphia/news/2013/04/24/teva-creates-new-group.html) plus the NIH and FDA sites, I have come to the realization and belief that Global is the new name under which TEVA is distributing the same failure of a product.

I noticed the inferior TEVA 300mg image here on this link with a 682 on it:

(http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm322160.htm) is one digit off of the Global tablet I have with a 681. I Googled it and saw the bizjournal article. Hence, my conclusion that TEVA and Global are one in the same.

The FDA site states that the TEVA 150 mg (presumably the Global 150mg) is not a problem. I am here to say that it IS A PROBLEM.
Therefore, I called my local CVS pharmacy to confirm that they still have the authorized generic from Watson and they tell me they only have Mylan and PAR manufacturers. I am so frustrated.

Of course, CIGNA Tel-Drug mail order is less expensive than my Cigna insurance price at a retail pharmacy CVS. However, I am willing to pay more to ensure that I get what works. Now CVS does not have Watson. Argh!

People have complained online that the PAR generic is horrible and apparently, they are in legal trouble with the fed. I guess I will give the Mylan a shot.

I have looked everywhere and can't find the "official" "authorized generic".

Glaxo Smith-Kline sold the brand to Biovail which makes the proprietary coating for branded Wellbutrin XL and the desirable generic. But I can't find anything about Watson.

Who has time for all this?

I agree 100% about the Global Pharm. 150mg generic Wellbutrin Xl being ineffective. Thank you so much for your post! Tom Thumb switched me 3 weeks ago from Watson and I feel horrible. I take two 150mg generics because the 300mg generics made me completely depressed. I was terrified to take the 300s and thought the 150s were supposed to be ok. The best is brand name Wellbutrin XL, but who can afford that? I actually felt great on that. Does anyone else have issues with Global?

Anyone heard about the results of the studies that were supposed to be completed by March 2013?

Not a word on the FDA website. Even if the results were late it's now been several months.

In my experience there is no question that all of the Wellbutrin generics for 300 XL are less effective, and the manufacturers have known for years.

Any updates on the results of the study that was supposed to be finalized in march 2013? I currently just switched to the generic of wellbutrin XL manufactured by mylan. I was on the brand for years since in the past the generic never worked. Now my insurance company will not lay for the brand name so I'm forced to switch back to the generic. I'm afraid of getting depressed again. Any information would be greatly appreciated.


Peoples Pharmacy response: we too are hoping for an update on the other generic bupropion formulations. The FDA has assured us that they are working on a report. We do not know why it is taking so long.

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!

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?

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.

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.

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...

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.

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!

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.

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