FDA Probe Clears Teva’s Generic Wellbutrin XL
13 CommentsBy Ed Silverman // April 16th, 2008 // 1:25 pm
The agency was investigating 85 post-marketing reports lodged early last year in which 78 patients who switched from Glaxo’s Wellbutrin XL 300 mg dose to Teva’s Budeprion XL 300 mg complained that 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.
The FDA began its review after ConsumerLab.com, a consumer-product testing group, published results showing key differences from the original, and a web site, peoplespharmacy.com, reported more than 250 people complained. Budeprion XL is made, by the way, by Impax Laboratories and sold by Teva Pharmaceuticals. In ConsumerLab’s test, the once-daily Budeprion XL released 34 percent of its active ingredient after two hours, compared to 8 percent for the original drug.
But the FDA issued a long-awaited report today saying the generic is “bioequivalent and therapeutically equivalent” to the brand-name pill. “Although there are small differences in the pharmacokinetic profiles of these two formulations, they are not outside the established boundaries for equivalence nor are they different from other bupropion products known to be effective,” the FDA writes.
“The recurrent nature of Major Depression Disorder offers a scientifically reasonable explanation for the reports of lack of efficacy following a switch to a generic product. The adverse effects (e.g., headache, GI disorder, fatigue and anxiety) reported following a switch were relatively few in number and typical of adverse drug events reported in drug and placebo groups in most clinical trials (i.e., including, but not specifically for, bupropion).” The agency also noted that th reported side effects were consistent with the adverse effects in labeling for generic Wellbutrin pills.
Tod Cooperman, who heads ConsumerLab.com, tells Pharmalot the FDA review is lacking. “It’s totally inadquate. The FDA found the product to be safe and effective, but the bioequivalency data they cite isn’t on the 300mg for which problems were reported. They use data for 150 mg product. On top of that, the data they have clearly shows the drug is releasing much faster than the original. It’s a huge leap of faith for them to conclude is safe and effective. They go on to cite some studies on antidepressants and recurrence rates, but it’s totally speculative.”
Here is Cooperman’s official statement. Meanwhile, a Teva spokeswoman tells us, not surprisingly, that the generic drugmaker is pleased with the outcome. “We constantly work to ensure that all of our products meet FDA’s comprehensive regulations governing the review and approval of generic drugs.”
Justice in Michigan
Disclosure: I own 100 shares of Teva stock.
Nevertheless … while the generic is within FDA’s bioequivalence guidelines, it is a rather tight fit on each end. And the peak time of plasma concentration is strikingly different.
Despite my personal interest that Teva does well, I would not be reassured as a pt. taking the generic by this report.
Laurie
Those on antidepressants can be VERY sensitive to even the slightest change in dose, or release time. This could be a very big problem for alot of people. The same thing happened in New Zealand when their nationwide health system went from Aropax to Loxamine. There was public outcty to get the Aropax back, since many were experiencing withdrawal from the different formula.
Ben Hansen
I looked at the consumerlab.com web site. Mostly they study vitamins and nutritional supplements, like fish oil and St. John’s Wort. The only prescription meds they’ve reported on are generic bupropion vs. Glaxo-SmithKline’s Wellbutrin, and generic metoprolol vs. AstraZeneca’s Toprol XL.
I’d be curious to know how much of consumerlab.com’s funding is provided by Big Pharma.
Janet
I was automatically switched by the pharmacy to the generic form of Wellbutrin XL once it became available. I take 300 mg dose. The first day, I began to have what felt like “withdrawal” symptoms (I know, Wellbutrin rarely has withdrawal effects but I’m one of the unlucky ones who always got them even if I was a few hours late taking the pill). This went on every day for over a week, and it never occurred to me to blame the generic bupropion. I told my doc that it just felt as if my meds were working their way out of my system too fast. He told me that there’d been such problems with others. I looked it up online and only then did I find out about this FDA investigation. Now I see that the FDA has decided that no problem exists. Well, it does. At least with the 300 mg gigantic horse pill! My doc supplied me with samples of the brand name version which will hold me for quite a while. Maybe after that I’ll just try taking 2 150 mg’s generics q.d. and see if that works.
pam
I take 450mg of Wellbutrin, 3 150mg tablets daily all at once in the morning. Last week my pharmacy dispensed the TEVA generic and since then I have experienced headaches severe to the degree that it requires 400mg ibuprofen religiously every 4 hours to keep them at bay. I have also experienced irritability, anxiety and GI issues. I did not know there were problems with the generic until today when on a hunch I Googled “generic wellbutrin” and came across the information. It was a relief to have an explanation for all that I have been feeling, but I know it will be a fight to get the insurance to cover the name brand.
Lisa Van S
Pam,..Good Luck. Be very careful w/ the irritability and anxiety you are feeling. Great source of support can be found at PaxilProgress.org.
Ken
I had been taking Wellbutrin XL 150mg once a day for awhile. I was switch to TEVA Wellbutrin XL 150mg. It does not work. I gave it about 2 weeks. Undesirable symtoms appeared - depression, sadness and more. I am trying to get my insurance company, that would be Tri-care Prime Humana and my doctor(s) to get them to “prior authoriztion” to the brand name. This is scary. In fact, I have started tappering, a pill every other day. If they don’t change it, I’m not going to take anything for depression, because I tried almost all the anti-depressants. Wellbutrin XL 150mg was the best. I see a class action law suit against TEVA on the horizon.
Elizabeth
I am in the same position as a lot of people who take Wellbutrin. I am on the Wellbutrin 150SR 2x per day. (I tried the 300XL and it just didn’t last long enough and taking it twice a day is much better.) I have tried the generic form and after a few days started to experience aches and pains in my arms and legs, soreness in my neck, headaches, irratibility and depression. I didn’t equate it to the generic meds until about two weeks later when I called my doctor nearly hysterical. She was the one who made the connection and since has requested the “Brand Name” on my Rx forms. However, now my insurance company (United Health Care) has dictated that EVEN THOUGH the doctor is specifying Brand Name Only I must now pay the difference between the generic form and the brand name form. It comes to about $170 per month. Needless to say this is going to be a true hardship and I am going to fight the insurance company until I get in trouble here at work!
Jan
Teva’s version of Wellbutrin needs to be taken off the market until they fix it. Just becuase FDA says it’s the same doesn’t mean it is. I bed if they did an actually study on it they’d realize it, instead of relying on other peoples studies. I’ve tryed both Teva’s 300mg and 150mg, and neighter work right. to add insult to injury after I went off Teva’s and back to name brand I started getting side effects I never had during my first 2 year run with name brand. They need to take it off the market until it’s fixed. Not to mention the insurance companies should not opt for the cheaper Teva, and go for the Watson generic wellburin. At least they have association with the company that makes name brand version. I tried Watson, and noticed not much of a difference. Teva is crap. I’d rather pay $100 a month for name brand than by into thier bogus study
Breathgiver
TEVA Welbutrin 150mg XL might be the exact same on the inside, but it is the shell that surrounds it that is different. It is not the same FDA, because I don’t feel right after taking generic for 12 days. I tappered it out of my system. My insurance will not change it despite a “name brand only prior authorization” letter from my PCP. Tried all other anti-depress…. I called today and a buracrat just said sorry. Not her fault though. The insurance is at fault, because they believe the FDA regardless of very real suffering people saying otherwise. I will live with it.Someone with a brain needs to help me
Breathgiver
My insurane company came through, because my good doctor showed evidence other meds were tried in the past. Thank you Tri-Care Prime Humana.
Now I have to get used to the 150mg original again.
MarryRose
Due to a change in our insurance I have to take 300xl Generic and I am stating it does not work at all! I have read and re-read all the data, etc. but I cannot seem to find anyone that says it works. I am not imagining it, I have been on the horse pill for about 2 months, and cannot concentrate am tired all the time, have blurry vision and oh yeah… the best part Depression! What kind of person would I be to continue with this nonesense. I am about to embark on a pricing search to try to find the best alternative at the most reasonable prices (my deductable is outrageous so it would not matter if my Dr. said the brand was required). If there is ever a law suit, sign me up.
Pete
I have the same problems as everyone else, started taking the generic form of XL, that’s when server headache, bad anxiety, night sweats and my depression came back. My insurance company stated I could appeal the coverage for them to pay for the name brand. Twice they shoot me down, even with the help of my doctor. They are saying that
The name brand is covered but I would have to pay 200+ because there is a generic equivalent . If it truly is the same drug, then why all the side effects?. No one, I mean no one has been able to give me an answer to that question. I can’t help to think that this truly is about money, plain and simple. I understand many companies are trying to be fiscally responsible but at what costs? There has to be a group effort here to have
The insurance companies, FDA and drug companies listen to the people they are supposedly trying to help. Is there a group, lawyer out there who can help organize
the little guy so they can get through this?