FDA To Review Generic Wellbutrin… Again
41 CommentsBy Ed Silverman // September 23rd, 2008 // 6:52 am
Five months after declaring a generic version of the Wellbutrin XL antidepressant is safe, the FDA will now conduct a human trial to investigate consumer complaints, The Wall Street Journal reports. Last April, the agency released a report of the once-daily generic drug, which is made by Impax Labs and distributed by Teva Pharmaceutical, that found the med is a “safe and effective choice for consumers.”
The FDA reviewed 85 post-marketing reports in which 78 patients who switched from Glaxo’s Wellbutrin XL 300 mg dose to Teva’s Budeprion XL 300 mg complained the pill simply wasn’t working, while others complained about various side effects, such as headaches and anxiety. These FDA noted the cases occurred at a time when sales data suggest that hundreds of thousands of patients using Wellbutrin XL were switched to Teva’s newly available generic (back story).
The FDA report was prompted by hundreds of postings on the People’s Pharmacy web site, which contained complaints of side effects from patients who switched meds. And an independent study by ConsumerLab.com found the once-daily Budeprion XL released 34 percent of its active ingredient after two hours, compared to 8 percent for the original drug.
“The FDA agrees it is important to study further the cause of these reports,” an FDA spokeswoman tells the paper.
Joe Graedon, a pharmacologist and co-founder of the People’s Pharmacy, wasn’t satisfied with the FDA review and tells the paper complaints about the generic are still being logged on his Web site. He argues the agency probe was unsatisfactory because it was based on data from the 150-milligram version of the drug, not the 300-milligram dose that is at the center of the complaints.
This past summer, Graedon and others were granted a meeting with senior officials from the FDA’s Center for Drug Evaluation and Research, and he tells the paper there was a “consensus” by the end of the meeting that the two sides could collaborate on a study that would involve patients who reported problems with the generic after taking the branded version. But he can’t begin a recruitment effort until he is given the details of the study design, and is still waiting to hear from the FDA.
The FDA spokeswoman says the agency still supports conclusions released in April. While it believes that critics “are attributing the wrong cause for the problem,” the agency also believes the complaints are “sincere” and is therefore prepared to do more work on the matter. “The FDA agrees it is important to study further if there is some specific reason…for the product to be not effective in these patients,” she tells the paper.
Officials from Teva weren’t available to comment to the paper.
Kath8562
(FYI- I work as a pharmacy tech)
Of course, there’s a small little problem right at the moment–brand Wellbutrin XL 300 is on backorder from the manufacturer- even if we want to give it to a patient, we can’t–because we can’t get it from any warehouse!
AGACE
This is very scary. I thought I was loosing my mind when the past month I have been so overwhelmed with the simple things in life that I can’t function well. I have headaches, tension, anxity, and a fog that just won’t go away. I can’t sleep well which then makes me sleppy all day! My ins. company won’t cover the Wellbuturn XL so now I have to go back to my doc. and switch. What a mess! The FDA needs to do a better job of studing these things for the people since the we pay them form our tax money! Thank God I found this website as well as the People’s Pharmacy website!
JamesMD
This generic is junk! It dumps the drug into the system and causes heavy sedation. The problem is in the XL delivery device with in the generic pill. instead of a gradual release you get a sudden release. This could increase the number of seizure from the medication…. this was markedly improved with the introduction of the extended release (XL) form of the drug.
Lisa1169
I’ve been on Wellbutrin for over 10 years and tried different forms. I can assure anyone that the generic does not work and I’ve tried different generic companies. I will admit that some of the generic seemed to work a very little bit, but nothing like the brand. So I pay the price to avoid paying the price. Best to all!
Sneezy
I just got mine filled this evening and it was $100.19 for 30 pills with insurance! $253.99 without insurance. My insurance will give it if the Dr writes brand nessessary on the script. The generic doesn’t work, I too have been on it for about 10 years. I thought I was nuts until I started reading other people were having the same problem.
Michele
I have been on Wellburtin for less than a year. I started with the brand and then the pharmacy filled my prescription with generic (ok by law in NJ). It took only a short time for me to feel a difference. I felt very anxious all the time. That feeling was absent when on the brand. So immediately I had my doctor note “no subsitution” and returned back on brand. I honestly feel the generic does not work as well.
Leoni
Wow. I have been on Wellbutrin for the past three years and, for the last several months, I’ve been overwhelmed with severe anxiety, sadness, loss of interest in activities like working out (which I could ALWAYS muster the motivation to do) and — most recently — serious thoughts of suicide. For the last several months I’ve been taking the generic of Wellbutrin. To think that could be the cause of this horrible relapse into darkness. FOR SHAME. I shudder to think how many people like me are suffering right now.
Louise
I’ve been on a rapid decline mentally. It helps to see the comments here. I am very depressed, and have been recently diagnosed with sensory neuropathy. The combination of the diagnosis with the lack of help from the generic have made people not want to be around me. Thank you everyone who has written thus far!
Margaret
I have been on generic for three months. I too have noticed a difference, maybe not as serious as the most of you. Mine has just had breakthrough depression, like I was on a sugar pill.
John
My insurance company jacked up the brand co-pay by $130 in order for force my switch to the generic 300mg. I noticed the change very quickly and notified my doctor. He switched me back to brand, but I’m having to cough up the higher copay every month. I’m still wrestling with my insurance carrier over this.
Anna
My pharmacist said it was all in my head when I told him about my experience with Budeprion XL; I had been using Wellbutrin for almost two years when the insurance company suggested I switch to save money on the co-pay. Within one month, I was feeling the black cloud of depression…and it was awful. I went back to Wellbutrin and all was well within another month.
I am so glad to hear the other stories about Budeprion and the fact that the generic is being reviewed. It wasn’t all in my head!
Janet
I have been sick for the last few days and the only thing I could come up with that was different was that I started taking the generic for Wellbutrin. Was from Tevan. I have flu like symptons being headache, body aches, exhaustion and a very noticeable mood change by people around me. I am so grumpy and have horrible anxiety. Kept thinking I may be coming down with something but now I believe it to be the switch to generic.
Zee
This is horrible, I can’t stop crying long enough to care for myself much less my children. Life feels unmanageable again, so as I approach the ‘why bother’ stage I found this info on the generics. Shame on the drug companies for selling this garbage! What about the people who don’t find this and do something stupid to themselves or others?? I was on wellbutrin xl for the last 6 years and everything was stablized and normal, no feeling of uselessness, dread or like I am just taking up space. now I only hope I can get the name brand in my system, before my feelings completely consume me.
Zee
I forgot to ad, I have only been taking the Teva generic for 20 days. so it has only taking 20 days for everything to completely fall apart.
Elisa
I went directly to my pharmacist before I filled my prescription and told them flat out that I’m not taking any generic form of Wellbutrin XL. They said there was “no available generic” for XL 150, but I will continue to be a paranoid nag about generics of this drug wherever I go. I just started taking it a few days ago.
Karen
Elisa,
I have the generic brand for Wellbutrin XL 150. So, your pharmacist is ill informed or just flat out dishonest! It is distributed by Teva and IT DOES NOT WORK! You have every reason to be paranoid about this particular generic brand!
Anne
After looking at this whole thing, I have this to say.
No one is nuts about what is working and what is not. I have actually read things that try to imply that it’s “in your head” type of response. If you are taking a generic that does not seem to be working as well as the Real McCoy, then stop right away and tell your doctor.
If you doctor doesn’t respond well enough to help you, then insist if you have to. You know your body, you self more then they do and it’s your right. Tell who you can, so we can all protect each other, since it doesn’t seem evident that those who are supposed to be helpful can actually do their job.
Safa
I reached the 4 week mark 5 days ago on general Wellbutrin. Is it supposed to be working to it’s full extent by now? Or does it START getting into your system after 4 weeks? I guess I just don’t completely understand… chocolate seemed to be a better placebo than this crap! It really stinks because aside from a few mind numbing head aches I have seen absolutely no effects from this. I am taking 150 mgs. Could it be the generic, or could it be that I need a higher dosage? Or could it be that I need a couple of months to see a change? Or could it be that I put too much faith in this being a miracle pill?
Mary
I had taken Wellbutrin XL 150 for about 4 years when I was switched to the generic. After about two weeks on Budeprion , I found myself at Wal-Mart in a frenzy. I was stuffing bags of chocolate candy into my cart . Whenever another shopper walked close to me or stood near me, I became agitated and angry. I wanted to hit them or worse. Somehow I got myself outside into my car and started hysterically crying. I called my pharmacist and went straight there . He gave me some of the real Wellbutrin and told me to throw the generic away. I shudder to think what would have happened if I had continued taking it.
Danielle
After having been on Wellbutrin XL for about 4 years, I too, was switched to the generic and within a couple of weeks all of my depression symptoms returned. I called my doctor, who, incidently, told me I was not the first person to complain about the Teva generic not working. I am back on the brand Wellbutrin XL and doing great again. I know this is not my imagination because all of my other drugs are generic and they work fine. Something is very wrong with this Teva generic and someone needs to seriously look into it before someone gets seriously harmed.
MP
I haven’t been able to read all the above comments becausse I am sitting here beginning to cry (again). I had to switch to the generic due to insurance reasons. After 6 months on the generic, I thought I was going crazy or hitting menapause much earlier than I wanted. I find myself snappng at those around me and then crying about it with guilt minutes later. I went online today to see if there was a higher dosage that i could ask the Dr. for. I never thought I’d find information like this!! and yet I feel such relief to know I’m not losing it. But the fact that myself and so many others are suffering from the generic brand consistently, this should be pulled off the shelves immediately before someone really snaps and hurts themselves or someone near and dear to them!!!!
Amanda
I, too, had no clue why my medication was not working anymore. I thought nothing about it being the generic version that wasn’t working, I just figured that generics were the same thing, as most people on here did. When I googled “Wellbutrin XL stopped working” I found a HUGE number of websites with complaints from patients about the generic Budeprion and everything made sense to me. I suffered through post-partum depression for over a year and was afraid to stop taking the medication because I thought I would get worse. I remembered how much of a God-send it was to me when I first started on it (when it was the brand name drug that I was taking)but once I finally stopped, I suprisingly felt 100% better. I am sooooo angry that I lost basically a year of my life taking that crap….a year that shouldve been the happiest of my life with the birth of my daughter. I am incredibly disappointed that the FDA doesn’t pull this generic with all of the complaints. It’s quite obvious that it is a defective medication and could cause someone their life.
vicky
I have only been taking Budeprion XL 300 mg for 3 days, and have never felt worse in my life. Crying for no reason for all 3 days, head in a cloud, can’t sleep any longer than 15-20 min intervals, my brain feels disconnected from my head. I was transfering from Efexor to Budeprion to help me stop smoking. As soon as I got into work today, I called my dr. and she told me to get off the medication. and not take it anymore. Just start taking the efexor again.
I will NEVER take this again
Salmon
Vicky,
It might not be that it isn’t working. It could be that it is working and you react badly to it.
JJ
Hi everyone I switched from my Wellbutrin 300 to the generic on fri Dec.19 I’m on day 3. I’ve used the Brand name for over 7months. Because my new insurance will not give a fair coverage for the name brand I had to switch. Today on Sunday 12/21, I’ve been crying all day,angry,and my suicidal thoughts are back in full swing. I’m scared because of the downward spiral. I called the pharmacist at Walgreens and she had me come in and she gave me one brand name tablet,to get me through til tuesday.She called my insurance co.,and they told her that they will not switch me back to my Brand name unless my doctor sends them a letter stating that I can’t do generic. Until this time I wait……………and wait…….. the FDA has tears on their hands.
JS
I took Wellbutrin 300 XL for awhile. When generics came out, I was switched to them. I had no problems with the generics, until I was given the Teva brand. Very soon after taking the Teva brand pills, my hands would shake and my vision would become distorted. My migraines started to get worse. About two months in (since I naively thought that I just had to get accustomed to this new form), I realized that my hair was falling out. I talked to my doc and my pharmacy. My doc said not to take the Teva brand, and my pharmacy started stocking another brand. All was well: I started to get tiny bangs across my hairline and lots of tiny hairs along my part within a few weeks. I take this medication to mitigate the symptoms of ADHD, so my heart goes out to the people who suffered such incredible emotional/mental effects. I thought mine were bad enough. Unfortunately, while I have been able to dodge Teva for the past year or so, I need to move my prescription to a pharmacy that, I was just told, only carries Teva - Costco. I don’t understand why it isn’t off of the market so that people don’t have to work so hard to avoid it. Maybe, I’m naive again. I hope that the FDA actually does something this time, instead of issue a statement that “depressed people are just sometimes suicidal.”
Jalen
I am very glad that I have discovered I was not alone. When I was switched from the branded product to the generic version within days I began having sever s/e. I have experienced crying spells, anxiety attacks, dark mood swings, severe depressive episodes. Also loss of ability to focus, concentrate and memory lapses. It has gone beyond suicidal thoughts, I have had four near misses in the last 9 weeks. I had to stop talking the medication altogether for fear that I would not be here. Now I guess I am to the point that I am afraid to take anything. I have seen a decrease in the most severe side effects and depressive episodes.
Gale
I never quesioned this being my problem until 2 days ago when I was trying to pinpoint when my moods changed so drastically. I was trying to relate it to anything I could find, but couldn’t find the precipitating factor. I went to take my Wellbutrin XL and it suddenly hit me. My brand name 150 mg dose was changed to generic about 4 months ago and things have continued to spiral downhill since then. I am irritable, quick to snap, and cry a lot. These are symptoms I have not experienced in a long time. I decided to research the comparison of the generic and brand online and was directed to several different sights. I think I have found the answer. Thanks
Becky
My husband has taken Wellbutrin for about four years. Originally it was given to him to help him quit smoking but he noticed that it also helped keep him calmer and from being depressed. He continued to take it after he quit smoking and it helped. However, when he was switched to the generic he complained that it did not feel the same and the anxiety came back. I agree that the FDA really needs to take a look at allowing the generic for Wellbutrin to be distributed.
Compounding Pharmacist
Compound Pharmacy has gained much popularity in the field of medicine. The medications are equally effective and safe for sick patients who cannot take the actual medications due to their personal allergies.
Kim
Ditto! I completely agree. I was on Wellbutrin XL 150 for two years and it worked well. My insurance company recently made the switch to the generic version. I (as well as my family)could tell within a couple of days that it didn’t work nearly as well. Then I thought it was all in my head because I’ve never liked generic brands of anything, especially with a drug like this. I mentioned it to my doctor who recommended I go back to the name brand. I instantly noticed an improvement. Unfortunately, the name brand now costs more than twice as much as it used to. Most days when I was on the generic I didn’t feel like I had taken anything at all. I noticed that especially in the evenings. This isn’t right and we need to get this changed. I’m going to start with my insurance company.
Mitch
I was taking generic Wellbutrin for almost 4 weeks as a means to ween off of Effexor. (Read the horror stories about that!) The first week was very managable, probably because of the small doses of Effexor I was still taking, but when the Effexor was gone, I hit rock bottom. I assumed it was the lack of Effexor causing my mania, but after reading about Bupropion i stopped taking my dose and after one day I feel improved. Now I’m quite sure my issues stem mostly from the Bupropion with the Effexor withdrawls just there to make my month even more difficult.
I won’t lie, this last month has shaken me to the core. There were many moments that i wasn’t sure I’d make it. I’m a 33 yr old male that should be a pillar of strength, not the emotional wreck I am now. I have 2 days until I see my psych, but I now know I’ll make it.
Thank you all for your entries, they have helped more than words can say.
shelley
I am in the same situation as so many of you. I have been so down and depressed, fighting these feelings for about a year now. It is funny that I just kept telling myself that it’s just me. This is terrible and very unfortunate that now I wont be able to pay for the authentic drug due to the price…if it is even available. I was finally doing great and then this generic had to change everything.
SUZ
WOW! I had no idea truly that this would be an issue. I am all for trying Generic..BUT NOT when it concernes mental health. It’s like going to the Beautician to talk about your “issues”. This is CHEMICAL and NEEDS to be addressed immediately. I can tell you that I have noticed a HUGE difference. As a matter of fact; things have been much better physically and emotionally in my life, but this GENERIC has been a complete failure. I am so tired, no desire to “function” or laugh, can’t focus at all. Do not go outside. NO, I am not a crazy person… I thought I was the only one here. Nice to know I am not alone in this.
chereese a.
You guys are really scaring me. I have the generic as well. I only took it for two days and I felt really funny.I had really bad headaches and worse then before. I stopped taking the meds because of the way it made me feel in just a few days. The pills I have are purple medium sized pills. I will talk to my doctor and ask him 2 please put me on the real brand.This site has helped me a lot.
Barbara
I’ve been having various side effects from Bupropian: sneezing, coughing, anxiety, tired to the bone, aches and pains. the ewal wellbuterin does not do that, nor I think does the other generic that is dark purple in color?
Kelly
Wow, Same story here. Insurance switched me to generic over a year ago after being on Wellbutrin for 6 years. I was happy about the $ savings at first. Little by little the generic version wasn’t working as well for me. It was subtle at first and I didn’t put 2 and 2 together. Since my depression had somehwat returned the DR. upped the generic from 300mg to 450. Talk about irritable! I had a co-worker tell me that I haven’t been myself for sometime and wondered if anything was wrong. I went to my DR. for a blood pressure check and mentioned that the Wellbutrin generic didn’t seem to be working and he said that it was a known documented fact that the generic did not perform as well as the Wellbutrin. I asked to be put back on it and had to come up with $150.00 but within a week I was my OLD happy self. So, why are insurance companies more interested in saving $ when the generic doesn’t work the same then in the best interest of their patients? Shame on them!
Olyvia
My doctor recently prescribed me Wellbutrin, but of course the pharmacy gave me the generic Budeprion SR (Teva). I swear i have been getting sick from it almost everyday. I have been throwing up and have no appetite. I called my doctor and she said that i should keep using it to see if it isn’t just anxiety. I have never taken the brand name but after reading these posts, i know i have been getting sick from this medication. We need to all inform the FDA of the dangers of this drug.
Alex
I have taking wellbutrin Sr 150mg generic from Glaxo Smith Kline for over two years. It has been really helpful for me, no complaint about it.
LEH
Here is the difference between the Wellbutrin from Glaxo-Smith-Kline and the generic by Teva. The GSK formulation is absorbed into the body at a little over 8% over 12 hours. Teva’s formula is absorbed at 43% in the first hour. This is a dangerous over-dose. It also leaves the body quickly, causing rebound symptoms from withdrawal. This medication has caused hypomania in many people, myself included. Why the FDA thinks this rapid absorption is a good idea completely mystifies me.
I was taken off of Teva’s formula and put on the GSK version in January of this year. I have had rapid improvement since then and feel better than I have in years.
Jennifer
I urge everyone here to report their bad experiences w/ Wellbutrin generics (esp. for 300mg XL) to the FDA. Do a Google search for “FDA Medwatch Reporting Form” and either submit your info online or download the form & mail it in with medical documents to support your statements. Yes, it’s an involved process & the form is a bit confusing - but this can encourage the FDA to investigate the safety of these generics & take our complaints seriously. I’ve had bad experiences w/ the Teva & Anchen generics, and the Watson generic actually put me in the hospital. This is happening to too many people to merely be “all in our heads”…