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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 4 of 4. This is the beginning of the thread.
Posted by qbsbrown on June 19, 2006, at 8:21:10
Real quick. I'm living in china, my PDOC is from Spain. I am returning to US soon. I'm taking Celexa.
She says, "I am not sure how
it works in US but our generics in Spain are allowed to content 10 or 20 %
less amount of chemical component... so you think you take 20 mg and you are
actually taking 18 or 16!! and that makes a difference!).So is it same in the states, or are they more strict, and have to have 100 percent same?
Regards,
Brian
Posted by bassman on June 19, 2006, at 13:28:18
In reply to What are FDA laws on Generics? Same %content?, posted by qbsbrown on June 19, 2006, at 8:21:10
Background: I've worked 25 years in the pharmaceutical industry and I HATE generics. Now I've got that out of the way. :>} The specs for generic drug content are the same as brand name in the US. Perhaps the confusion is that for bioavailability (often, just the concentration of the drug in the serum after dosing), the generic spec is +/-20% of the brand name. That's not as bad as it sounds, because a lot of that 20% is experimental error- it's not a given that two brand name lots would be within 20% of each other in biofluids. But the spec on the tablet, capsule, etc. actual drug content is exactly the same, generic vs. brand.
Posted by qbsbrown on June 19, 2006, at 18:20:51
In reply to Re: What are FDA laws on Generics? Same %content?, posted by bassman on June 19, 2006, at 13:28:18
I've worked 25 years in the pharmaceutical industry and I HATE generics.
You didn't say why you hate them.
Posted by bassman on June 20, 2006, at 6:24:03
In reply to Re: What are FDA laws on Generics? Same %content?, posted by qbsbrown on June 19, 2006, at 18:20:51
"Hate" is too strong a word, sorry. “Concern” is more accurate. It's a long story, and the merits of generics have been debated at least a few times on this board. As I mentioned in my last post, it would appear from outward appearances that generics should be equivalent to the brand name, more expensive drug. The biggest advocates of generics, are, unfortunately, pharmacists, who make a great deal of profit on generics, but not on brand names-and so it is hard for them to be unbiased; and we tend to trust what a pharmacist says over what a big, greedy pharmaceutical company says.
I could write several, tiresome pages on the subject, but what it boils down to for me is that generics are made by the cheapest process possible that will allow them to pass testing-and on a formulation that may or may not be equivalent to the brand name. Throughout the years, generic house have been caught doing a lot of slimmy things. Generic houses make very large lots of “pills” and don’t really have any primary interest as to the quality, impurities, or effectiveness of the medication they are producing. One of my fears is that people initially take a generic; find out it doesn't work for them and move on to another drug-when in fact the first drug would have helped them, had it been the brand name. So my advice is to try the brand name drug first, see if it works for you and then switch to the generic if finances dictate. Then if the generic doesn't work, be suspicious that it is the generic formulation, not the drug, which is not working. If after the generic drug has been working well for a period of time and then it abruptly stops working, I think it is worth trying the brand name (or some of the generic which was working and you have saved for just such an occasion) before deciding to change meds.
This is the end of the thread.
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