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Generic Depression Medication Found Ineffective

December 7, 2012 Natasha Tracy

Some time ago, I wrote about generic medications. I explained that generic medications are bioequivalent to brand name medications within a given margin. Generic medications may use binding and other inactive agents that are different from the brand name medication. All of this can lead to a generic being less effective than the brand name drug in a small percentage of cases. Usually though, the generic works just fine for people and the switch is unnoticeable.

And all that information was correct.

But new information has arisen. And it’s alarming information to me. It’s information on exactly how bioequivalence is determined for medication and in the case of one generic medication, the generic of Wellbutrin XL 300 mg, it caused an ineffective drug to be allowed on the market for many years.

How is Bioequivalence Determined?

This is important.

I won’t get into all the details but suffice it to say how bioequivalence is determined by the Food and Drug Administration (FDA) has to do with blood or plasma levels of the drug, peak concentration, time to peak concentration and a few other things. A single dose of the brand name or generic drug is given to a small number of healthy volunteers to determine these numbers (there are lots of problems right there, in terms of methods, but that’s not what this is about).

But the really shocking part is this: some medications make it onto the shelves without this testing at all, and this is what happened to the 300 mg version of Wellbutrin XL manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals.

What the FDA did with this particular drug was run their tests on the 150 mg version of the generic drug and then use math to extrapolate to the 300 mg version, assuming that the 300 mg version worked the same.

Seriously. The 300 mg drug went through no testing. That drug could have been Pez for all the FDA knew.

Complaints About Generic Wellbutrin (Bupropion)

And while the FDA thought this was peachy, patients noticed the difference and complained about it. They actually complained about it for years before anyone took action. I have known about the issue with this particular drug for years but honestly had assumed it had been dealt with. That’s an oops on my part, but then, I’m not exactly the FDA.

But What About Other Generic Drugs?

The generic Wellbutrin in question has been pulled from the shelves. Well it’s about bloody time, but presumably if the FDA used this approach with this one drug then it has used it with others, right?

Right.

And the FDA is handling this fact very badly (if you ask me). They are asking the drug manufacturers to run tests on those generics that were approved using this approach and submit the data by March 2013. Oh, for gosh sakes. That’s the biggest conflict of interest one can imagine.

What Can Patients Do About Generic Drugs?

But the important part is what you can do for yourself, and basically, it’s like this: if you switch from a brand name drug to a generic and you have a reaction, the generic may be causing it in your particular case. Maybe that’s the fault of the FDA, maybe the drug manufacturer, maybe your own body chemistry, but the difference is there, no matter what.

If you find that this happens to you, you can do one of two things:

  1. Find out if there’s another generic available and take that
  2. Switch back to the brand name drug

Sorry, but those are pretty much your only two choices. And yes, I realize that some insurance companies won’t cover brand name drugs when generics are available but then you have to decide if you think paying for the brand name is worth it for you. (Or you can always take your insurance company to task and report, with your doctor’s help, that the generic doesn’t work for you and see if you can get any leeway. However, I’m not sure how successful an approach that would be.)

And yes, you can always report any problem you have to the FDA or Health Canada.

Don’t Abandon Generic Medications

But look, this isn’t about scaring you into abandoning generics. I believe the vast majority of generics work the vast majority of the time. I use generics and if I were a doctor, I would prescribe them, usually, but that’s me.

And, hopefully, the FDA will get their ducks in a row when testing future generics and we won’t be in this pickle.

Nevertheless, it’s still important to realize that it could happen that you could have a negative response to the change to a generic. At least that way you can check and see for yourself and make a more informed decision.

You can find Natasha Tracy on Facebook or GooglePlus or @Natasha_Tracy on Twitter.

APA Reference
Tracy, N. (2012, December 7). Generic Depression Medication Found Ineffective, HealthyPlace. Retrieved on 2020, February 26 from https://www.healthyplace.com/blogs/breakingbipolar/2012/12/generic-depression-medication-found-ineffective



Author: Natasha Tracy

Natasha Tracy is a renowned speaker, award-winning advocate and author of Lost Marbles: Insights into My Life with Depression & Bipolar.

Find Natasha Tracy on her blog, Bipolar BurbleTwitter, Instagram and Facebook.

Natasha Tracy
February, 15 2013 at 6:53 pm

Hi Katherine,
First of all, thank-you for reaching out. What you did is important and it shows that you're fighting your suicidal feelings. You want to live. That's why you posted here.
Secondly, please call a helpline right now: http://www.healthyplace.com/other-info/resources/mental-health-hotline-numbers-and-referr…
The people who staff the helplines will be able to talk to you one-on-one and refer you to other resources that can help you more.
Finally, you may wish to read something I have written on this subject. Please keep in mind that it's on my personal blog and is not affiliated with HealthyPlace. http://natashatracy.com/mental-illness-issues/suicide/want-die-what-should-do/
I see people reaching out a lot and so I've written that for all of you.
Most importantly though, don't give up. You're a fighter. I know that because you're fighting right now. Now take the next step. Get help from someone else. Call a helpline, go to an ER or call someone to come and sit with you. Your life is worth a phone call. Make that call.
- Natasha

KATHERINE
February, 15 2013 at 4:29 pm

I don't know what to do, I am feeling very suicidal. I need "Help or to talk to Someone Now".

Julie
January, 13 2013 at 9:17 am

I never would have thought taht not getting feeling any better could be from a generic medication. I currently take 120 mg of Cymbalta AND 300 mg of the generic Wellbutrin. I have been seeing the same psychiatrist for about 6 years now. Have I made a mistake staying with this doctor? I don't like meds and don't want to take them so I'm not one of those just out for the high. Most people don't even know I have a depression issue, I'm really good at faking a "normal" "happy" life. Should I ask for the name brand or just find a new doctor?

Janine
December, 12 2012 at 7:48 am

Wow.
Natasha, do you know when they took the generic Wellbutrin 300 mg XL off the shelves? I just picked mine up from the pharmacy two days ago!
Thank you.

Martha
December, 11 2012 at 6:23 am

The same thing happened to my son but it was with the recently generic version that just came out this pass June for Lexapro for depression. he went down the hill until we figure it out that the problem was the generic brand, it was just not working. Thanks to the doctor support and Insurance, he went back to the main brand and is doing great again. Since now on, only main brands medicines for his mental illness problems. Thanks for a great information.

Becky
December, 10 2012 at 6:27 am

Family member just went back on Wellbutrin XL (the 150 mg). I priced the brand name ($350 for 30 days) reduced to about $150 if using the "coupon" on the brand manufacture's website. The website stated: Get brand name WELLBUTRIN XL® (bupropion HCI) extended release tablets at a co-pay price similar to or lower than the generic versions. Eligible patients pay as little as $4 for each 30-day supply for up to 12 uses (up to a $50 savings for each 30-day supply).
The 30 days of generic - $7 and change. I don't see how $150 is "similar to or lower" than $7.00.

Mary
December, 9 2012 at 3:29 pm

When generic Lamictal came out I was switched to it while inpatient. The hospital stay didn't do me much good and I returned home still in a bad space. I had brand name Lamictal at home and started taking it again, assuming after I finished it I'd be switching to the generic. But when I started taking name brand again I got bette and so the generic isn't effective for me. My pdoc overrules medicare/medicaid and they have to cover it because it is medically required for me.

Michael
December, 7 2012 at 5:45 pm

I was very interested to see that this drug came from Teva. I suffer from migraines and have been given a generic form of imitrex (sumatriptan) also distributed by Teva that I have found to be entirely ineffective. Because my insurance co-pay for the brand name is $100 for 9 pills (!), I've given up on triptans and am just using OTC NSAIDS. I'm just wondering if Teva is a particularly bad source of generics.

Kris Magnusson
December, 7 2012 at 9:00 am

I have been taking 300 mb generic Wellbutrin XL tabs for a year and it really might have been like swallowing a 300 mb Certs candy. I have been so depressed at various points this year that I couldn't go to work, couldn't get any work done, didn't have enough energy to cook or clean, and have been suicidal on and off the whole year. In short, this Wellbutrin thing has hosed my work and life for a *year*. Finally, last week, I had had enough and my psychiatrist put me on Prozac. I can actually feel that working.
The people responsible for this SNAFU need to make reparations forthwith.

Stephanie Hansen
December, 7 2012 at 8:45 am

My daughter was repeatedly switched from the brand name drug for her epilepsy to the generic and had to be switched back because she reacted badly and it was far less effective. I take the same drug now for my epilepsy and the generic brand is less effective for me too but the government disability support program I'm on will only pay for the generic brands of drugs if they're available. Now they're trying to do the same thing with the depo provera injections I take. The problem with that is that it is an injection I take once every three months. If I reacted badly to the generic brand it would mess me up for 3 months! I can't risk that as someone who is bipolar with epilepsy. I have to go to the disability support people and lobby my case because I can't afford the name brand and I take it in part because it helps greatly to control my seizures by controlling my hormones. The name brand of my epilepsy medication costs in the hundreds per months and would be WELL beyond my means.

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