In 2007, The People’s Pharmacy, a newspaper drug advice column by Joe and Terry Graedon, noted on their website that they started getting reports from people taking a generic form of Wellbutrin called Budeprion XL 300 mg. These reports discussed how patients taking the generic version of this antidepressant weren’t experiencing the same beneficial effects of the medication as when they were taking the name-brand version. And the side effects were often worse.
The Graedons became so concerned that they commissioned an independent lab analysis of the generic version of Wellbutrin manufactured by Impax Lab and Teva Pharmaceuticals in 2007. This report found that the generic version of Wellbutrin simply wasn’t equivalent to the brand-name version.
In April 2008, the FDA reviewed their existing studies, and concluded they were the same. The FDA did not review the independent analysis, or any actual data on the 300 mg version of the product (you know, the one people were actually complaining about).
Here it is more than four years later, and the U.S. Food and Drug Administration (FDA) finally agrees with the independent analysis, the Graedons, and the hundreds of people who’ve complained about the efficacy of Budeprion XL.
How many thousands of people took generic Wellbutrin with little positive antidepressant effects over the past 5 years only to be hornswaggled, not only by pharmaceutical companies, but by the very government agency empowered to police them?
To show you how screwed up the FDA process is in regards to this dangerous situation, read this paragraph from the FDA news release:
The Impax/Teva product, Budeprion XL 300 mg, was approved in December 2006. Soon after, FDA began to receive reports that patients who were switched from Wellbutrin XL 300 mg to its generic counterparts were experiencing reduced efficacy. FDA analyzed those reports and concluded that the complaints appeared to be linked to the Impax/Teva product.
FDA therefore asked Impax/Teva to conduct a study directly on its 300 mg extended-release product to compare its bioequivalence to Wellbutrin XL 300 mg. FDA asked that the study include patients who had reported lack of efficacy after switching from Wellbutrin XL 300 mg to Budeprion XL 300 mg. Impax/Teva began the study, but terminated it in late 2011, reporting that, despite efforts to enroll patients, Impax/Teva was unable to recruit a significant number of affected patients to generate the necessary data.
So way back in 2006 — six years ago! — the FDA had reports that something was amiss with this drug. It wasn’t working. Patients weren’t getting better on it.
They waited. And waited. And waited some more while the drug company was tasked with conducting one, single, simple study. Five years after the FDA told the company to do the study, the company said, “Nah, we can’t do it. It’s too hard.”
In 2008, the FDA — in an effort to cover its own ass — simply reiterated how it tests generic drugs. At the time, they didn’t require drug manufacturers to test higher doses independently, so they were just going off of the generic data for the 150 mg version of these drugs. They apparently failed to even take a look at the independent analysis commissioned by the Graedons and conducted by ConsuemrLab.com. Doh!
Apparently being deaf, dumb and blind, the FDA decided instead to commission its own study in 2010 (three years after already having the data showing these drugs were not bio-equivalent). Why? Because the patient reports kept coming in despite the FDA’s and Teva’s reassurances that these drugs were the same. (I imagine them saying, “Dumb patients! What do they know?”)
In 2010, in light of the public health interest in obtaining bioequivalence data, FDA decided to sponsor a bioequivalence study comparing Budeprion XL 300 mg to Wellbutrin XL 300 mg. This study was conducted in 24 healthy adult volunteers and was designed to measure both the rate and the extent of release of bupropion into the blood. The results of this study became available in August 2012, and show that Budeprion XL 300 mg tablets fail to release bupropion into the blood at the same rate and to the same extent as Wellbutrin XL 300 mg.
An astounding amount of time passes once again. I’m not sure why it takes nearly 2 years to run a small study of only 24 patients, but hey, I guess since we’re only talking about people’s lives here, no hurry. Thanks FDA!
Five years ago, the FDA knew these drugs were not bio-equivalent, despite its cursory ass-covering 2008 review. During those 5 years, Teva was allowed to continue marketing and selling Budeprion XL 300. How many people died ((for instance, by taking their own lives because the depressive symptoms were still just too much?)) while taking an ineffective antidepressant during those 5 years? Why it took 5 additional years — making thousands of U.S. citizens suffer — isn’t answered in the news release.
And I suspect it never will be.
Read the FDA Alert: FDA Update: Budeprion XL 300 mg Not Therapeutically Equivalent to Wellbutrin XL 300 mg
Read the blog entry over at the People’s Pharmacy: Patients Vindicated! Generic Wellbutrin (Budeprion XL 300) Withdrawn
11 comments
Its a Government they don,t care about people the new breed of drugs have serious medical affects on people suffering mental health problems no wonder people refuse to take the drugs they are prescribed .Its very sad thankfully there are people like you who care .Elizabeth Kelly Australia .
THANKS a Bunch Dr.John for this Very Informative Post!:) My heart goes out to Everyone affected!:(
As caregiver, i immediately noticed the differing so-called “benefits” of the generic Wellbutrin. Due to insurance circumstances,hubby, Chato Stewart, was refused the “real” stuff. How sad/difficult for those in need to be put in the situation of: something (generic) is better than nothing at all. i find it totally outrageous that anyone could target the sick/vulnerable for dishonest profit!
I am wondering if this is also true for the 150mg dosage? You alluded to that, but I was unable to come to a firm conclusion. My mother has been on the 150mg for about 5 years and continues to suffer from depression. They recently increased the dosage to two a day and she still is not feeling relief. Her insurance won’t cover anything but the generic. I wonder how much she has suffered needlessly???
I was given 150 mg generic version for 2 weeks in 2010 and it made me worse (thinking I was losing my mind and suicidal). So there are a ton of people that have written into people’s pharmacy (a website)–type in “generic Wellbutrin” and you’ll see story after story of it not working. I was amazed to find out I wasn’t the only one going thru this. I’m back on name brand and better. It might work for some people, but not all. Good luck.
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I can attest to the Teva being inferior, within weeks of switching pharmacies and receiving a different generic manufacturer I could feel a difference. I’ve never been on brand Wellbutrin, I can’t afford it as my insurance won’t cover it. $10/month generic vs $280/month, as Joan commented- something is hopefully better than nothing.
It happen to me I call the Dr. and she said is the same, I told her I feel bad.They don’t beliave me
I am suffering with this for one year.
I took generic WellButrin XL 150 mg the year before I became pregnant. I think it was ineffective in treating my depression – I had headaches and insomnia and my lack of clear thinking resulted in life altering consequences…. Our son will be four years old next month and has Encephalopathy – unspecified, Autism with severe mixed receptive / expressive language disorder. I went back on the generic WellButrin for post-partum depression and breastfed for two weeks which I think dried up my milk supply…. Who knows what adverse effects any medications have on epigenetics?? Environment (drugs, GMO food, etc.) altering gene expression.
I am in a similar situation. I have never been on name-brand Wellbutrin, but did well on Anchen Buproprion for about a year. Teva was the manufacturer of the Budeprion that I switched to about a year ago and within a few days I was experiencing shaking, couldn’t stop crying, severe anxiety….etc. I suspected the difference in medications and learned the hard way the manufacturer can certainly have an effect, not only the difference between generic and brand name. After that I have had all my scripts written specifically from Anchen for the Buproprion generic of Wellbutrin XL 300mg. Just last week I received my most recent refill via mail order and it wasn’t for XL, it is for yet another version of Buproprion 300 XR from Anchen which luckily seems to be working for me. Now I realize Anchen had to pull all of their Buproprion XL300’s from the market because of this recall and the FDA asking them to do further testing. What a joke this has been a known problem all along. At least now I know for sure it wasn’t me imagining the problems.
i took this garbage and yes i had serious issues and yes that makes me angry.
I’d been saying that the generic Wellbutrin never worked for me (even though mine was 150 mg dose, it doesn’t matter if it’s a higher/lower dose) and the mail order pharmacy switched without my consent. I had crying episodes where I thought I was losing my mind, and suicidal thoughts for 2 weeks, this happened in 2010. I had to have my doctor write a do no substitute name brand only. Well the mail order pharmacy did it again in 2011 and I took my business back to a local CVS. I may be paying a higher price, but that’s the price of sanity. My husband and therapist were scared that I’d hurt myself if I didn’t get switched back and I did. I’m better emotionally now. Why do mail order pharmacies switch with something that “might” help,but is cheaper they assume for patients and mess with people’s brain without a phone call prior? That’s just wrong. It may work for some people.