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Why you sometimes have problems with Generic Drugs
  1. #1
    zippysgoddess is offline Platinum Member
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    Default Why you sometimes have problems with Generic Drugs

    Some people have disagreed with me when I explained about the 20% plus or minus difference that the FDA allows for generic drugs, some have insisted this was only for the inactive ingredients. So I have done some more research on this subject, and NO! the 20% difference IS NOTjust limited to the inactive ingredients.

    ***"[u]Are There Any Differences Between Generics and Brand-Name Drugs? </u>

    ...it should be noted that current regulations permit a variation of up to 20% either way in the bioavailability of the active ingredient. (See this Food and Drug Law Institute overview of the Hatch-Waxman Act of 1999.) In one study (Borgheini 2003), a 31% variation was found in the blood plasma levels of a particular medication after a patient switched from a branded to a generic product. (Why does this happen? It may be accounted for by differences in the manufacturing process yielding different particle sizes that are absorbed at different rates, as well as other factors.) "***

    So yes, this gives them a leeway of 40% on manufacturing these drugs, they can be significantly different than their name brand counterparts, and in some cases the effect can mean a drug doesn't work at all, or may have too much of the active ingredient, resulting in serious effects or even fatalities!


    For some of you, I know this will be a relief as you can now know for sure that if a generic seems to work different, it is not all in your head. Simply said, poor quality control and poor testing, means poorly made drugs from some companies.
    Last edited by ddcmod; 04-08-2013 at 01:34 AM.

  2. #2
    bn7
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    The majority of board members of the FDA have ties and conflicts of interests with drug companies left, right and center..... combined this with all of G.W.BUSH's appointees to the FDA that are put in place to serve the Bush families financial interests in Eli Lilly.....then add on the fact that pharmaceutical companies are that powerful they can easily sway any the government, the FDA or anyone that stands in the way of their profit margins....

    Loads of drugs passed by the FDA have horrendous side effects many lethal and these brand name drugs cure nothing and are no more effective than placebo's in treating the targeted symptoms. Drugs are all about profit, to hell with peoples health.

    Why single out generic drugs as bad? Brand name drugs are no safer.

  3. #3
    pharmd06 is offline Member
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    zippy makes a good point, but remember drugs are tested by each lot (batch). Brand companies have the same error margin. the fda does monitor random lots and any generic company that does not comply gets reprimanded heavily. There has not been a lot of problems with generics since the 1970s with digoxin.

    bn7, what did large drug companies ever do to you? have you ever been sick or taken an antibiotic? do you know how much money and time is vested in one drug to get to the market?
    remember, drug companies need to make tons of money and have political say. it is because of drug companies that new drugs are made and new drugs save lives. just because they have money and are good at making money does not make them evil. if we stopped making new drugs after penicillin in the 1940s a lot less people would be alive today. if you are so worried about them making too much money buy some stock.
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  4. #4
    zippysgoddess is offline Platinum Member
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    But what bn says about the conflicts of interest is very, very true. You can easily find all the information to prove this just by doing simple searches online.

    They do sometimes pass drugs way to fast, without proper testing.

    And while you say they are subjected to batch tests, most of these tests are carried out by the drug companies own testers or scientists, not the FDA or any other uninvolved party. The FDA freely admits, in their own press releases, that they do not have enough funding or enough employees to do rigorous testing of any manufacturing company on a regular basis.

    You are very defensive of the drug industry, and while there are some good, reliable companies, a lot of them are just as bad and corrupt as any other industry in corporate America.

    Look at what happened last year with Able Labs. They were having quality control issues for a long, long time, and this caused many of their drugs to have too much or too little of the active ingredients. No one did anything, and the FDA did no specific testing, until there were repeated complaints from many different doctors and consumers.

    When I have a bottle of Oxycodone IR 5mgs, all capsules look identical and have the same identical markings from Ethex, but yet they all vary in strength and the way the help or not when I take them, something is wrong. I can have some that do nothing at all, like they have no active ingredient, some that are fine, and other times I can take one and get sick as if I took too many, all in the same bottle.

    This is not the first drug I have had this happen with, and if you look around these boards and search on other sites, you will find many, many people with the same problems and complaints.

    It is especially easy to tell when you are a chronic pain patient, you know, after awhile of use, how much certain drugs do for your pain and where your levels are after you take them. When a drug is worthless, you can tell, and you can also tell the difference between when you have built a tolerance and just need a different drug or a higher dosage, and when they were just manufactured sloppily.

    I know you are not supposed to share drugs, but at first, I did think it was just me, or maybe all in my head. So I had my husband try the Darvocet I used to take, when I had the name brand from my old pharmacy it was always fine. Then we moved, I switched pharmacies and they had a generic, same scenario, some good ones in the bottle, some bad ones, and some that were too strong. I didn't tell him why, just one day his back was sore, and I said here try this. He did, and then he commented on the same thing after trying a couple.

    The same thing with Oxy.

    I began to do research on it, and found out that generic drugs are notorious for this.

    Oh trust me, bn has darn good reasons for feeling the way he does and he knows what he is talking about.
    Last edited by ddcmod; 04-08-2013 at 01:34 AM.

  5. #5
    zippysgoddess is offline Platinum Member
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    There you go bn, assuming stuff again. I told you, you always think the worst of me.

    Yes, I know there are problems with name brand drugs as well, I was however, trying to explain why so many people have problems with generic drugs. The problems between the two are quite different.

    There are many, many safety issues that are never addressed with name brands, you are correct on that, however, when it comes to quality control, they are much more stringent then, because they are trying to get a new drug onto the market and approved by the FDA, so it is under more scrutiny than it will be by the time it is available in generic form. Also the companies that produce name brands, that sell for top dollar, can afford to have more people on staff to do the tests and they can also afford to spend the extra time it takes to do the tests.

    The smaller guys, who later release the generics, do not have the same funding sources and income coming in, as the companies that do the name brands, so they are forced to slack in some areas. Since they are not the ones that have to get the drug approved for human use, they cut corners elsewhere.

    So they are both cutting corners and causing dangerous problems to consumers, but in different ways.
    Last edited by ddcmod; 04-08-2013 at 01:36 AM.

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