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Problems with Budeprion XL (generic Wellbutrin)


LOS ANGELES (July 2, 2009)--  On May 29, 2009, the law firms of Milstein Adelman & Kreger along with Kanner & Whiteley filed suit in Los Angeles Superior Court against three drug manufacturers regarding the companies’ extended release version of the anti-depressant Wellbutrin, known as “Budeprion XL.”  Similar actions have been filed in Pennsylvania, Louisiana, North Carolina, and Texas.

Since Budeprion XL’s introduction in 2006, numerous consumers who had previously been treated with Wellbutrin XL reported adverse side effects upon switching to Budeprion XL, including headaches, insomnia, nausea, and mood swings.  Many patients also reported a loss of antidepressive effect.  Patients who thereafter switched back to Wellbutrin XL or an alternative generic (such as Bupropion XL manufactured by Watson Pharmaceuticals) saw a return of the antidepressive effect and lessening of side effects.    

The lawsuit alleges that the manufacturers of Budeprion XL misrepresented and omitted important information regarding differences in the generic drug’s formulation and active ingredient release rate which have the potential for serious complications.  Plaintiffs contend that these differences between Budeprion and Wellbutrin carry the increased potential for adverse side effects and the decreased likelihood in the drug’s effectiveness.

Despite knowledge of these differences, the drug companies made assertions that Budeprion XL was identical to Wellbutrin XL.  Additionally, the drug companies disseminated false information to patients and their physicians.  Examples of these misrepresentations include:

• Claiming that the time to peak plasma concentration (Tmax) of bupropion hydrochloride after ingesting Budeprion XL is identical to that in Wellbutrin XL, when studies have confirmed that the Tmax for Budeprion XL is less than one-half of that for Wellbutrin XL;
• Claiming that Budeprion XL did not carry with it a risk of dose dumping when taken with food, though reports have indicated that food may increase chance for toxicity;
• Claiming that human studies were done comparing Budeprion XL to Wellbutrin, when in fact no such studies were done; and
• Claiming that the peak plasma of other key metabolites was equivalent to that found in Wellbutrin, when in fact no studies were done.

As a result of these misrepresentations, doctors do not have the information necessary to treat their patients.  Moreover, consumers are misled into believing they are getting a pill identical to Wellbutrin, when this is not in fact true.

By the end of 2007, bupropion hydrochloride was the fourth-most prescribed anti-depressant in the United States, with over 20 million retail prescriptions.  Data from this time shows that approximately 400,000 patients nationwide utilized Budeprion XL.

Plaintiffs are seeking monetary damages and an injunction forcing the companies to stop making false assertions regarding Budeprion XL’s efficacy.

More information about the lawsuit can be found at http://www.budeprionclassaction.com/.  Consumers who have been harmed by Budeprion XL are encouraged to share their story and contact class counsel.
5 Responses
Avatar universal
Those symptoms just happened to my mom . She just got out of the hospital due to wellbuterin
Avatar universal
how do you find out who the manufactor is
Avatar universal
This is good, I hope they get a hefty Law suit slapped on them.
This kind of thing comes as no shock to me thanks to our FDA's loose regulations when it comes to Generic drugs on the market.

In terms of "active ingredient" the FDA states that drug companies making a generic drug must stick to the 20% Law. This means that amount of active ingredient can be no more or no less than 20% of the brand name drugs active chemical.

Do the makers of generic drugs stick to this Law? NO. In fact many do not and the reason for that is because this FDA drug Law is not enforced, watched, or tested.
The whole thing is simply done on the Honer system.

I know what your saying, "no way that can be true!" You better beleive it is true.
Independent studys in many laboratorys have found a huge amount of generic drugs that have as much as 40% less active chemical in them than the brand name counter part!

The list is in the hundreds. Just to name a few, Lamictal (Generic Lomotragine) made by one generic drug company was discovered to have 38% less active chemical in it than brand name Lamictal. This fact has caused many break thru sezures in patients that take the drug for Sezure related illnesses. Was the maker held accountable? Nope.

Lithium is another drug that has been discovered to have much less active ingredient than it's name brand counter part (Lithobid)

There are also many other antidepressant generic meds that do not pass the 20% rule.
Actually I think the FDA allowed variance should be more like 5%.

You would think that the FDA has an army of inspectors that are always checking this stuff, but the truth is that they don't and the whole thing is done on the honor system.

This is not a joke and I am not some paronoid guy that is saying this. There is a lot of documented proof that this is more the rule than the exception.

Go to a web site called crazymeds.com and you can read for yourself all the test studys that have been done that clearly show the inferior quality of Generics.

This kind of thing really pisses me off because in the case of Psychotropic meds, it is hard enough for us to find meds that work and this **** only makes it that much harder.

My P-doc had to double the amount of generic Lamictal I was taking because it was not working. It wasn't working because it has so much less active chemical in it.
I can not afford name brand drugs so I must use generic antidepressants.

They say they are the same, but that is a lie. The reason the Generic drug companies do this is because 1. They know they won't get checked and 2. because doing this saves them millions of dollars a year in active chemical costs.

I think this is a serious issue, but no one is blowing a whistle so the FDA stands by and does nothing as they always have.

You will hear a lot in the media about restructuring health care. They never talk about "mental health care" nor do they ever talk about the high cost of drugs and what should be done about that. In fact they never talk about anything drug related.

If your like me then your health care cost are low, but your meds are sky high. I'm not worried about my broken arm, rather I much more worried about my mental health care.

My Psychiatrist visits are cheap compared to my monthly drug costs.
Avatar universal
Wellbutrin Budeprion Generic is a Nightmare!!! I can't believe how bad it's become after 4 weeks. I decided to wait to see if the side effects would subside however they actually became worse. I feel out of control, hopeless, not myself, extreme lack of motivation, unable to perform the simplest tasks due to lack of desire. All I do is lay around and try to figure out why I can't get motivated, so very weird and surreal

1. Crying all the time
2. Unable to motivate
3. Unable to sleep
4. Nausea
5. Heart papulations
6. Depression worse
7. Short tempered
8. Anxiety
9. Agitation
10. Bad nightmares
11. Gained 10 pounds in 3 weeks
12. Bad taste in my mouth
12. Did I say I feel worse than ever!!!

Generic should be banned! FDA should pay attention to consumer complaints
Avatar universal
Budeprion XL 300 mg was a nightmare for me.  

more anxiety
more depression
more insomnia
more headaches
more weight loss (which i liked!)
more powerful in quitting smoking (which it did successfully do).

I've taken Watson's generic.. It made my hair fall out.
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