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Author: Admin | 2025-04-28
Do brand-name psychoactive drugs work better? "The medication seemed to stop working. Michael has been crying a lot again, and having major meltdowns...he even ran into the street one day and nearly got hit by a car. He can't get his homework done. It feels like we're back to square one. But it dawned on me that his Wellbutrin looked different when I picked it up last month. I checked the bottle and it said 'budeprion.' " (Generic for Wellbutrin XL.) After hearing similar complaints about this same drug, I called the FDA and spoke with a physician in the generic drugs division. She was not impressed, and stated that the number of complaints about generic Wellbutrin was too low to justify concern. When I told her there were entire message boards dedicated to people who'd had adverse reactions to the generic Wellbutrin, including suicidality, she informed me all I could do was make an adverse event report. This was about five years ago, and the number of complaints for generic Wellbutrin was 80. After one report took me two hours to complete, I gave up and tried to make the rest of the reports by phone. However, because most of the cases were children who were being prescribed Wellbutrin for ADHD, they would not take the reports. (Wellbutrin is approved for major depression and ADHD in adults, but only for major depression in children. It's a good non-stimulant treatment for ADHD but does not have an FDA indication: it is an "off label" use.)Generic drugs are supposed to be deemed "bioequivalent" by the FDA, which means they should have the same amount of active ingredient as their brand counterparts as demonstrated on healthy volunteers. They do not test whether they actually work or not (ie efficacy/effectiveness). A review of studies comparing bioequivalence and therapeutic effectiveness of generic vs. brand psychoactive drugs concluded that bioequivalence and effectiveness are not necessarily the same, and recommended more rigorous testing for toleratibility and efficacy in actual patients--not just healthy volunteers (Borgheini, 2003).Furthermore, these are psychoactive substances we are concerned with here. How do we know they are crossing the blood-brain barrier? Crossing it at rates equivalent to the brand name? Or that they are not modified when and if they do? Plasma level does not necessarily equal bioavailability in the brain. And, if a generic is manufactured overseas, how do we know that subsequent batches after receiving approval are of the same quality and quanitity? I recently met a rep from a well-known chemical company (whose name I won't mention) who had traveled to India to visit their generic drugs plant. "Let me tell you something," she said. "Anyone that says that generic drugs are the same as brand name is lying." She went on to tell me how appalling the plant conditions were, and that there were major safety and contamination concerns. This reminded me of a weight-loss drug study that was conducted at three centers, one of which was in India.
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