FDA To Review Generic Wellbutrin… Again
20 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.