Generic antidepressant pulled from U.S. shelves after FDA finding

[JRLeft]

Administration took a highly unusual step this week: It acknowledged that a widely used generic drug -- a copycat of the antidepressant Wellbutrin XL -- was not the equivalent of the original drug produced by GlaxoSmithKline since 2003.

The move prompted the world's largest manufacturer of generic drugs, Israel-based Teva Pharmaceuticals, to stop shipping its generic extended-release bupropion -- marketed as Budeprion 300 mg XL-- and to remove it from U.S. shelves.

The FDA finding marks an about-face for the food and drug safety agency, which in 2009 responded to public concerns by flatly declaring Teva's Budeprion XL "bioequivalent and therapeutically equivalent to (interchangeable with) Wellbutrin XL 300 mg."

The agency's reversal came after a five-year kerfuffle that has called into question its unqualified assertion that all generic medications work exactly as the more costly "pioneer drugs" they are intended to mimic. With millions of American patients switched -- often without notification -- to newer, cheaper forms of the drugs they take, this week's acknowledgment by the FDA may open a small chink on the agency's so-far impenetrable armor on generic drugs.

"The FDA is not infallible," write Joe and Terry Graedon, who publish the column "The People's Pharmacy," and run an online forum by the same name. "Just because the agency says all generic drugs are identical to their brand-name counterparts does not make it so."

The Graedons, whose column long ran in The Los Angeles Times, say they have also collected "a great many other complaints" about the generic forms of the beta-blocker Toprol XL (metaprolol) and the anti-seizure drug Keppra (levetiracitam), and have urged the FDA to look into them.

Read more at the link: http://www.latimes.com/health/boostershots/la-heb-generic-antidepressant-equivilency-20121005,0,3111072.story

[still_one]

1. This is significant. I have used generics that are not as effective as brand name

[bananas]

2. The Graedons have a weekly podcast which is really good

Here's their article about this news story: http://www.peoplespharmacy.com/2012/10/03/generic-wellbutrin-budeprion-xl-300-withdrawn-vindication/

edit to add: they answer a lot of questions in the comments section

[LTR]

3. I actually take this drug!

I have been taking bupropion, the generic version of Wellbutrin. A month and a half ago, my doctor switched me to a time-release version (which we both thought would be more effective). This is the Budeprion XL referred to here. I just checked the bottle.

I haven't noticed any significant difference from the original bupropion I started taking several months prior (I also take generic Prozac), but I will certainly mention this to my doctor and pharmacist. I have noticed some symptoms returning, but I know I'll need an increase of the other drug. I do crave cigarettes less (a known effect of Wellbutrin). Thanks for the heads-up!

[undergroundpanther]

4. Fuck I take it too

and I'm on MA. They ALWAYS give generic,hmm..big pharma being MA cheaters,somehow this does not suprize me.No wonder I go back to the hospital..In the hospital I get the brand name feel better get discharged and begin to get overwhelmed.....And I bet they'll get away with it.Fuckers. Fuck the poor,is how the rich are,so give us fake wellbutrin..,so we get depressed and die,that's how they reduce ppl being on medicaid.I hope the rich suffer for the crimes they do,and they suffer forever.Hated everywhere by everyone until they kill themselves.