WASHINGTON — Teva Pharmaceuticals has stopped shipping its generic version of a popular antidepressant after a federal analysis showed the pill does not work properly.
The Food and Drug Administration on Wednesday said it asked Teva to withdraw Budeprion XL 300 after new testing showed the drug releases its key ingredient faster than the original drug Wellbutrin XL 300, made by GlaxoSmithKline.
Budeprion releases its ingredient faster? This sounds so......familiar. Of course it was from a long time ago I'm thinking of...let me see if I can remember....
I will say however, that when I dispense and you take a generic drug, we both expect it to be the same as its brand name equivalent, and that dumping 49% of a 24 hour dose over the course of four hours as opposed to 25% is not the same. It's almost twice as much. Which makes me wonder if maybe there's not a reason at least a few of my customers are so damn psycho .
It's also why I've started ordering Watson's version of Wellbutrin XL.
Wow. That was way back in January of 2011. Whoever wrote those words must be some sort of prophet or something. I mean.....
Wait! That was me! I remember now! I'm the prophet!! You should probably praise me and ask me to do miracles now or something.
The action contradicts the FDA's previous update on the issue in 2008, when regulators said the drugs are essentially the same.
Actually, that's being kind. According to the prophet, what happened was the FDA extrapolated results from a test of 150mg tablets to the 300mg ones. They tested one thing and assumed the results would apply to something else. As we all know, assumption is the cornerstone of science.
And by the way, even the test of the 150mg tablets didn't go so well.
"Oh prophet" some of you are no doubt saying. "Might you have any other words of wisdom for us poor lost souls who trust that authority figures are wise and just?"
Yes. Never trust anyone who calls himself a prophet. It was actually The People's Pharmacy that broke this back in 2006. Good on them.
Still, I ran the story a year and a half before the paper, which I think earns me a little praise. Is there some level between a human and a prophet? A prophan?
Maybe the paper will be faster when it's the daily data upload. I'm not hopeful.
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PS- By the way, the guy who left this comment on that original post back in 2011?
Irrelevant! So much for pharmacists being drug experts.
All y'all need to go back to your pharmacokinetics textbooks and brush up on steady-state.
tsk tsk Drug Monkey.
He can suck it. Totally suck it.
7 comments:
Muhammad Drug Monkey.
Maybe the homeostatic level of neurotransmitters doesn't work like electrolytes? i.e. ordinary drug dissolution tests in water or simulated digestive juice isn't truly or totally indicative? Anyway, it is a shame for FDA scientists that it took so long for disparity between pharmacokinetics vs. pharmacodynamic consensus to result.
How does one reproduce the effects of spreading out a newspaper over one's breakfast (or holding it in front of one's spouse's diatribe, or clean the windows, or playing fetch with a pooch, or refraining from the newsprint allergy effect?) We'll miss these aspects of newspapers and have to come up with something else that replaces this 'cherished' tradition?
I am peddling pharmaceuticals that are being cooked up all over the world. In addition the actual generic is changing for some people from fill to fill to "save money". I would bet that the FDA has lost control of not only the OTC's...Herbals...but also a lot of these "obscure" generics houses. A little baksheesh to your Congressman/Senator can go a looong way.
Peter Tietjens
Nice catch, DrugMonkey!
I actually printed out the graphs from your 2011 post and brought them to my doc after I had experienced some serious bruxism after being on the generic for about two months. My teeth hurt for like a week straight. Changed to 'Do Not Substitute' and everything's been fine since...
What I need to know is: who do I sue?
This is one of the reasons drugs cost so much. Your teeth hurt for a week so you deserve a big settlement. Sue everyone. Make it harder and more expensive for all of us to get medicine.
All hail Drug Monkey! Hosanna in the highest!
Now, for the miracle, would you see that Big Retail Pharmacy gets their come-uppance? You have a near-perfect platform, and with the smallest amount of urging, I think you could get any suggestion of participation from pharmacists (as long as the employed don't have to risk their jobs too badly) to go viral. I think the time is nigh.
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