http://www.peoplespharmacy.com/2012/09/03/generic-wellbutrin-budeprion-xl-300-withdrawn-vindication/
Patients Vindicated! Generic Wellbutrin Withdrawn
Terry Graedon September 3, 2012 Default 72 Comments
We are reposting our People’s Pharmacy Alert from October 3, 2012 because of The New York Times article about “An Increase in Scrutiny for Generics.”
On October 3, 2012, the Food and Drug Administration announced that it was asking Teva Pharmaceuticals USA, Inc., to remove its generic version of Wellbutrin XL 300 from the market. The generic formulation, Budeprion XL 300, was deemed “not therapeutically equivalent to the reference listed drug (RLD), Wellbutrin XL 300 mg.”
This is a huge victory for patients! Their heartbreaking stories about side effects and therapeutic failures linked to Budeprion XL 300 were finally heard. They should feel vindicated. We have never given up advocating for people who contacted us over the last five years complaining about problems with the Teva generic antidepressant. Here is what the FDA announced:
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What lessons are we to draw from this incredible boondoggle?
First, the FDA is not infallible. Just because the agency says all generic drugs are “identical” to their brand name counterparts does NOT make it so. The Budeprion XL 300 story proves that. The FDA deserves kudos for recognizing that this problem needed to be addressed and for carrying out its own tests of bioequivalence. Here is how the FDA explains its study.
Second, what other drugs might be problematic? The People’s Pharmacy has received a great many other complaints about generic formulations. Two that come to mind instantly are generic forms of the beta blocker Toprol XL (metoprolol) and the anti-seizure medicine Keppra (levetiracetam). If the FDA conducted its own tests on these generics the way it did for Budeprion XL 300, we wonder what the agency would find.
Third, just because your pharmacist or insurance company says that all generic drugs are fine and dandy does NOT make it so! If you are experiencing problems just cite the Budeprion XL 300 example and ask them to reconsider their dogmatic stance.
If you would like to learn the entire inside story behind this incredible saga you may want to read our chapter titled “Generic Drug Screwups” in our book, Top Screwups Doctors Make and How to Avoid Them. You will learn much more about the FDA’s ability to approve and monitor generic drugs and how to protect yourself from generic drug problems.
Thanks for taking time to consider what we think is an important health news story.
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