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Is it possibe to experience withdrawal when switching generics???????


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Yes, I had the same experience as you (and others on BB). It was many years ago, so I don't recall what the new benzo was. But I switched from clonazepam to a different benzo generic. I did not think it would be a big deal, but day after day after day I felt worse & worse. It was really dreadful. Finally, I realized that this nightmare started when I switched from clonazepam to the other benzo generic. I went back to my doctor, got clonazepam again & within a few days I felt relief. I was back to whatever is "normal" for me.

 

BTW, I met a doctor who was a real a**hole & told me that people can keep switching from one benzo to another day after day w/o negative side effects. This does not relate to your question that much, but I just needed to vent  :(

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It was bound happen sooner or later guys... :(

 

I have to say I was a bit sceptical at first too, but I waited and watched before I opened my mouth and it soon became clear that all was not right with generic changes..

 

So this is from someone who doesnt have skin in the game..

It seems to me to be those that are more sensitive, by situation or in body, that are effected more..

That would be as opposed to those that never have to find sites like BB to discontinue a drug that after all only takes “4-6 weeks” to get over.. Yeah, I know, Dont we all wish.. But im sure I could find “study's” that say that.. (if I could be bothered wasting my time)

 

Im also not so sure its the actual dose of medication, but perhaps other ingredients in a less obvious way..?? But thats just kinda a guess.. -I dont have a lab or know how to use one..

But I find it interesting that I can find posts going back near 10yrs stating how that many have serious problems once adding a little alcohol and water (DLMT) too.. Though luckily most can fix that with a little time or slower/partial C/O..

-Sadly these people can also be told its in their head..

 

All I can say with any certainty is that I feel for those affected, let down in yet another aspect of this whole mess... We shouldnt even have to consider this as a potential problem..

 

:(

 

Ps, if anyone reading has attempted updosing their way back to stable on the new and offending generic, I would love a PM on your experience...

Thanks..

:)

 

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I think one factor may be that people who are going through withdrawal already due to tolerance or tapering ascribe their symptoms to changes in sources. I've switched between clonazepam manufacturers or generic valium to liquid from another company while NOT changing my dose and suspending my taper and had absolutely no issues.
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I think one factor may be that people who are going through withdrawal already due to tolerance or tapering ascribe their symptoms to changes in sources. I've switched between clonazepam manufacturers or generic valium to liquid from another company while NOT changing my dose and suspending my taper and had absolutely no issues.

Im sure that is one factor.. It was my first thought too, but it became pretty clear to me as certain “cases” presented, that there was more to it..

 

Its a bit like me saying I have come off benzos (3+months) twice before and didnt notice a problem, therefore Benzo WD doesnt exist beyond what many Drs would say..

 

But I do understand the need to be cautious and scrutinise these things.. Just because it Can happen, doesnt mean it Must be what the OP might be suspecting..  Like you say, there would be things I would rule out first depending on situation..

 

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I worked in the pharmaceutical industry as a quality control chemist and in quality assurance. It was not for a generics manufacturer. The company I worked at made extended release tablets.

 

Yes, there are rules about  bioequivalence studies for generics vs the name brand. Back when I was in the industry, a generic manufacturer only needed to show one study that showed bioequivalence. They didn't need to show the FDA any study that failed to meet that criterion. Not sure if it's still true today. This as opposed to the original brand names that have to show the FDA ALL studies run with the drug, good or not.

 

The "40%" myth probably comes from the testing requirements for tablets. The testing rules say results of any individual tablet have to be plus or minus 20% of the label claim. 20% below to 20% above makes a total of 40%, right? Yes, theoretically. But FDA (and EU) rules also say that every batch has to be formulated with enough drug so every tablet should come out theoretically at 100%. Also, when the rules say that when 20 tablets are tested all together, the results must be plus or minus 10% of label claim. The allowed differences are due to manufacturing variability and test result variability. No, test results are not absolute numbers. If you could test one tablet over and over you'd get different results. For those of you dry cutting with scales, just think how variable your weights are all the time. The same thing happens with test results from a chemical test.

 

On to the Indian (and Chinese) generics manufacturers... The FDA often finds serious problems when they inspect those plants. Process validation studies are often seriously deficient, or lacking altogether. (Process validation is showing that the process makes the same product that meets specifications time after time.) Whenever I get a generic I look up the inspection history of the manufacturer on the FDA website, especially looking for warning letters. Some Indian manufacturers are pretty good (like Dr Reddy's Laboratory and a few others whose names I can't remember). Some have horrible reputations with the FDA. Of course, US manufacturers can be the same way. I remember reading an inspection report for Schering Plough for one of their products made in the US (Illinois? Pennsylvania? I don't remember), and there was obviously some shoddy work going on at that plant.

 

Any manufacturing plant that makes drugs for the US market must be inspected by the FDA every 2 years. The extent of those inspections can really vary, especially depending on the enforcement budget allotted to the FDA for making these inspections. The trend is during republican administrations, the budget is low, and inspectors are very lenient when they inspect manufacturing plants. During democratic administrations the budget tends to go up and inspections get a little tighter. When Bill Clinton became president and he put Kessler in as commissioner of the FDA all of a sudden the FDA pressed those thumbscrews down on manufacturers!

 

So yes, one generic may be a shoddy product when compared to another generic. All pills are supposed to have 100% of the drug they say they have. But if the manufacturing process is not very good, you could get iffy pills. Mixing powders together is a very inexact science. And especially with the stronger benzos (alprazolam, lorazepam, clonazepam) where the pills my have as little as 0.5 mg drug in them, compared to the entire weight of the tablet at 150 mg or so, then you're talking about 0.3% of the tablet has drug in it. The manufacturing process needs to be really consistent. And a generic manufacturer just wants to make pills as cheaply as they can. They don't want to spend the money to make their manufacturing process as good as it can get. Of course, if some pills have a lower amount of drug in them than what they say they have, other pills in the batch will have a higher amount of drug in them. A batch of tablets for commercial distribution is at least 250 kg. If the tablets are 0.3% drug, that means the batch has 0.75 kg of drug in it. 0.75 kg drug mixed around in 250 kg. That's like half a teaspoon of sugar in a pound of flour. How well can you mix that together?

 

My own experience switching generics for my alprazolam... I went from Accord to Activis with no problem. The pills were the same color (pink) but different shapes (round vs oval). Then I was switched to a yellow football shaped tablet and all hell broke loose! It was like I had suddenly completely stopped taking the pills altogether. I had to up my dose, which was really disappointing. Now I'm back on Activis, and all is right with the world again.

 

Goodness I've droned on...

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I worked in the pharmaceutical industry as a quality control chemist and in quality assurance. It was not for a generics manufacturer. The company I worked at made extended release tablets.

 

Yes, there are rules about  bioequivalence studies for generics vs the name brand. Back when I was in the industry, a generic manufacturer only needed to show one study that showed bioequivalence. They didn't need to show the FDA any study that failed to meet that criterion. Not sure if it's still true today. This as opposed to the original brand names that have to show the FDA ALL studies run with the drug, good or not.

 

The "40%" myth probably comes from the testing requirements for tablets. The testing rules say results of any individual tablet have to be plus or minus 20% of the label claim. 20% below to 20% above makes a total of 40%, right? Yes, theoretically. But FDA (and EU) rules also say that every batch has to be formulated with enough drug so every table should come out theoretically at 100%. Also, when the rules say that when 20 tablets are tested all together, the results must be plus or minus 10% of label claim. The allowed differences are due to manufacturing variability and test result variability. No, test results are not absolute numbers. If you could test one tablet over and over you'd get different results. For those of you dry cutting with scales, just think how variable your weights are all the time. The same thing happens with test results from a chemical test.

 

On to the Indian (and Chinese) generics manufacturers... The FDA often finds serious problems when they inspect those plants. Process validation studies are often seriously deficient, or lacking altogether. (Process validation is showing that the process makes the same product that meets specifications time after time.) Whenever I get a generic I look up the inspection history of the manufacturer on the FDA website, especially looking for warning letters. Some Indian manufacturers are pretty good (like Dr Reddy's Laboratory and a few others whose names I can't remember). Some have horrible reputations with the FDA. Of course, US manufacturers can be the same way. I remember reading an inspection report for Schering Plough for one of their products made in the US (Illinois? Pennsylvania? I don't remember), and there was obviously some shoddy work going on at that plant.

 

Any manufacturing plant that makes drugs for the US market must be inspected by the FDA every 2 years. The extent of those inspections can really vary, especially depending on the enforcement budget allotted to the FDA for making these inspections. The trend is during republican administrations, the budget is low, and inspectors are very lenient when they inspect manufacturing plants. During democratic administrations the budget tends to go up and inspections get a little tighter. When Bill Clinton became president and he put Kessler in as commissioner of the FDA all of a sudden the FDA pressed those thumbscrews down on manufacturers!

 

So yes, one generic may be a shoddy product when compared to another generic. All pills are supposed to have 100% of the drug they say they have. But if the manufacturing process is not very good, you could get iffy pills. Mixing powders together is a very inexact science. And especially with the stronger benzos (alprazolam, lorazepam, clonazepam) where the pills my have as little as 0.5 mg drug in them, compared to the entire weight of the tablet at 150 mg or so, then you're talking about 0.3% of the tablet has drug in it. The manufacturing process needs to be really consistent. And a generic manufacturer just wants to make pills as cheaply as they can. They don't want to spend the money to make their manufacturing process as good as it can get. Of course, if some pills have a lower amount of drug in them than what they say they have, other pills in the batch will have a higher amount of drug in them. A batch of tablets for commercial distribution is at least 250 kg. If the tablets are 0.3% drug, that means the batch has 0.75 kg of drug in it. 0.75 kg drug mixed around in 250 kg. That's like half a teaspoon of sugar in a pound of flour. How well can you mix that together?

 

My own experience switching generics for my alprazolam... I went from Accord to Activis with no problem. The pills were the same color (pink) but different shapes (round vs oval). Then I was switched to a yellow football shaped tablet and all hell broke loose! It was like I had suddenly completely stopped taking the pills altogether. I had to up my dose, which was really disappointing. Now I'm back on Activis, and all is right with the world again.

 

Goodness I've droned on...

 

That was an excellent post, most definitely did not drone on, thank you!  Mary 💜💜💜

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I worked in the pharmaceutical industry as a quality control chemist and in quality assurance. It was not for a generics manufacturer. The company I worked at made extended release tablets.

 

Yes, there are rules about  bioequivalence studies for generics vs the name brand. Back when I was in the industry, a generic manufacturer only needed to show one study that showed bioequivalence. They didn't need to show the FDA any study that failed to meet that criterion. Not sure if it's still true today. This as opposed to the original brand names that have to show the FDA ALL studies run with the drug, good or not.

 

The "40%" myth probably comes from the testing requirements for tablets. The testing rules say results of any individual tablet have to be plus or minus 20% of the label claim. 20% below to 20% above makes a total of 40%, right? Yes, theoretically. But FDA (and EU) rules also say that every batch has to be formulated with enough drug so every tablet should come out theoretically at 100%. Also, when the rules say that when 20 tablets are tested all together, the results must be plus or minus 10% of label claim. The allowed differences are due to manufacturing variability and test result variability. No, test results are not absolute numbers. If you could test one tablet over and over you'd get different results. For those of you dry cutting with scales, just think how variable your weights are all the time. The same thing happens with test results from a chemical test.

 

On to the Indian (and Chinese) generics manufacturers... The FDA often finds serious problems when they inspect those plants. Process validation studies are often seriously deficient, or lacking altogether. (Process validation is showing that the process makes the same product that meets specifications time after time.) Whenever I get a generic I look up the inspection history of the manufacturer on the FDA website, especially looking for warning letters. Some Indian manufacturers are pretty good (like Dr Reddy's Laboratory and a few others whose names I can't remember). Some have horrible reputations with the FDA. Of course, US manufacturers can be the same way. I remember reading an inspection report for Schering Plough for one of their products made in the US (Illinois? Pennsylvania? I don't remember), and there was obviously some shoddy work going on at that plant.

 

Any manufacturing plant that makes drugs for the US market must be inspected by the FDA every 2 years. The extent of those inspections can really vary, especially depending on the enforcement budget allotted to the FDA for making these inspections. The trend is during republican administrations, the budget is low, and inspectors are very lenient when they inspect manufacturing plants. During democratic administrations the budget tends to go up and inspections get a little tighter. When Bill Clinton became president and he put Kessler in as commissioner of the FDA all of a sudden the FDA pressed those thumbscrews down on manufacturers!

 

So yes, one generic may be a shoddy product when compared to another generic. All pills are supposed to have 100% of the drug they say they have. But if the manufacturing process is not very good, you could get iffy pills. Mixing powders together is a very inexact science. And especially with the stronger benzos (alprazolam, lorazepam, clonazepam) where the pills my have as little as 0.5 mg drug in them, compared to the entire weight of the tablet at 150 mg or so, then you're talking about 0.3% of the tablet has drug in it. The manufacturing process needs to be really consistent. And a generic manufacturer just wants to make pills as cheaply as they can. They don't want to spend the money to make their manufacturing process as good as it can get. Of course, if some pills have a lower amount of drug in them than what they say they have, other pills in the batch will have a higher amount of drug in them. A batch of tablets for commercial distribution is at least 250 kg. If the tablets are 0.3% drug, that means the batch has 0.75 kg of drug in it. 0.75 kg drug mixed around in 250 kg. That's like half a teaspoon of sugar in a pound of flour. How well can you mix that together?

 

My own experience switching generics for my alprazolam... I went from Accord to Activis with no problem. The pills were the same color (pink) but different shapes (round vs oval). Then I was switched to a yellow football shaped tablet and all hell broke loose! It was like I had suddenly completely stopped taking the pills altogether. I had to up my dose, which was really disappointing. Now I'm back on Activis, and all is right with the world again.

 

Goodness I've droned on...

[/quote

 

if this is droning on, then by all means please do and do so often!  ;)  you explained this so eloquently and simply enough that anyone could understand.  :thumbsup:

i just wish people would refrain from saying those with bad experiences are wrong and that it's all in our head ...ESPECIALLY when we're right and we're sane.  touche'

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I worked in the pharmaceutical industry as a quality control chemist and in quality assurance. It was not for a generics manufacturer. The company I worked at made extended release tablets.

 

Yes, there are rules about  bioequivalence studies for generics vs the name brand. Back when I was in the industry, a generic manufacturer only needed to show one study that showed bioequivalence. They didn't need to show the FDA any study that failed to meet that criterion. Not sure if it's still true today. This as opposed to the original brand names that have to show the FDA ALL studies run with the drug, good or not.

 

The "40%" myth probably comes from the testing requirements for tablets. The testing rules say results of any individual tablet have to be plus or minus 20% of the label claim. 20% below to 20% above makes a total of 40%, right? Yes, theoretically. But FDA (and EU) rules also say that every batch has to be formulated with enough drug so every tablet should come out theoretically at 100%. Also, when the rules say that when 20 tablets are tested all together, the results must be plus or minus 10% of label claim. The allowed differences are due to manufacturing variability and test result variability. No, test results are not absolute numbers. If you could test one tablet over and over you'd get different results. For those of you dry cutting with scales, just think how variable your weights are all the time. The same thing happens with test results from a chemical test.

 

On to the Indian (and Chinese) generics manufacturers... The FDA often finds serious problems when they inspect those plants. Process validation studies are often seriously deficient, or lacking altogether. (Process validation is showing that the process makes the same product that meets specifications time after time.) Whenever I get a generic I look up the inspection history of the manufacturer on the FDA website, especially looking for warning letters. Some Indian manufacturers are pretty good (like Dr Reddy's Laboratory and a few others whose names I can't remember). Some have horrible reputations with the FDA. Of course, US manufacturers can be the same way. I remember reading an inspection report for Schering Plough for one of their products made in the US (Illinois? Pennsylvania? I don't remember), and there was obviously some shoddy work going on at that plant.

 

Any manufacturing plant that makes drugs for the US market must be inspected by the FDA every 2 years. The extent of those inspections can really vary, especially depending on the enforcement budget allotted to the FDA for making these inspections. The trend is during republican administrations, the budget is low, and inspectors are very lenient when they inspect manufacturing plants. During democratic administrations the budget tends to go up and inspections get a little tighter. When Bill Clinton became president and he put Kessler in as commissioner of the FDA all of a sudden the FDA pressed those thumbscrews down on manufacturers!

 

So yes, one generic may be a shoddy product when compared to another generic. All pills are supposed to have 100% of the drug they say they have. But if the manufacturing process is not very good, you could get iffy pills. Mixing powders together is a very inexact science. And especially with the stronger benzos (alprazolam, lorazepam, clonazepam) where the pills my have as little as 0.5 mg drug in them, compared to the entire weight of the tablet at 150 mg or so, then you're talking about 0.3% of the tablet has drug in it. The manufacturing process needs to be really consistent. And a generic manufacturer just wants to make pills as cheaply as they can. They don't want to spend the money to make their manufacturing process as good as it can get. Of course, if some pills have a lower amount of drug in them than what they say they have, other pills in the batch will have a higher amount of drug in them. A batch of tablets for commercial distribution is at least 250 kg. If the tablets are 0.3% drug, that means the batch has 0.75 kg of drug in it. 0.75 kg drug mixed around in 250 kg. That's like half a teaspoon of sugar in a pound of flour. How well can you mix that together?

 

My own experience switching generics for my alprazolam... I went from Accord to Activis with no problem. The pills were the same color (pink) but different shapes (round vs oval). Then I was switched to a yellow football shaped tablet and all hell broke loose! It was like I had suddenly completely stopped taking the pills altogether. I had to up my dose, which was really disappointing. Now I'm back on Activis, and all is right with the world again.

 

Goodness I've droned on...

[/quote

 

if this is droning on, then by all means please do and do so often!  ;)  you explained this so eloquently and simply enough that anyone could understand.  :thumbsup:

i just wish people would refrain from saying those with bad experiences are wrong and that it's all in our head ...ESPECIALLY when we're right and we're sane.  touche'

 

While I agree with many of the things you mentioned, that is it's possible that some companies do shoddy work, I respectfully disagree with your contention that mixing 0.75 kg drug into 250 kg of filler is such a huge technical issue in 2019.

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While I agree with many of the things you mentioned, that is it's possible that some companies do shoddy work, I respectfully disagree with your contention that mixing 0.75 kg drug into 250 kg of filler is such a huge technical issue in 2019.

 

Maybe it's more that they don't want to spend the money to do it right? I've ready quite a few inspection reports and warning letters for companies making tablets where the process validation results were wonky and all over the place, and companies kept testing batches until the results were what they wanted them to be while simply discounting the "wrong" results as "lab error" with no supporting proof.

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I worked in the pharmaceutical industry as a quality control chemist and in quality assurance. It was not for a generics manufacturer. The company I worked at made extended release tablets.

 

Yes, there are rules about  bioequivalence studies for generics vs the name brand. Back when I was in the industry, a generic manufacturer only needed to show one study that showed bioequivalence. They didn't need to show the FDA any study that failed to meet that criterion. Not sure if it's still true today. This as opposed to the original brand names that have to show the FDA ALL studies run with the drug, good or not.

 

The "40%" myth probably comes from the testing requirements for tablets. The testing rules say results of any individual tablet have to be plus or minus 20% of the label claim. 20% below to 20% above makes a total of 40%, right? Yes, theoretically. But FDA (and EU) rules also say that every batch has to be formulated with enough drug so every tablet should come out theoretically at 100%. Also, when the rules say that when 20 tablets are tested all together, the results must be plus or minus 10% of label claim. The allowed differences are due to manufacturing variability and test result variability. No, test results are not absolute numbers. If you could test one tablet over and over you'd get different results. For those of you dry cutting with scales, just think how variable your weights are all the time. The same thing happens with test results from a chemical test.

 

On to the Indian (and Chinese) generics manufacturers... The FDA often finds serious problems when they inspect those plants. Process validation studies are often seriously deficient, or lacking altogether. (Process validation is showing that the process makes the same product that meets specifications time after time.) Whenever I get a generic I look up the inspection history of the manufacturer on the FDA website, especially looking for warning letters. Some Indian manufacturers are pretty good (like Dr Reddy's Laboratory and a few others whose names I can't remember). Some have horrible reputations with the FDA. Of course, US manufacturers can be the same way. I remember reading an inspection report for Schering Plough for one of their products made in the US (Illinois? Pennsylvania? I don't remember), and there was obviously some shoddy work going on at that plant.

 

Any manufacturing plant that makes drugs for the US market must be inspected by the FDA every 2 years. The extent of those inspections can really vary, especially depending on the enforcement budget allotted to the FDA for making these inspections. The trend is during republican administrations, the budget is low, and inspectors are very lenient when they inspect manufacturing plants. During democratic administrations the budget tends to go up and inspections get a little tighter. When Bill Clinton became president and he put Kessler in as commissioner of the FDA all of a sudden the FDA pressed those thumbscrews down on manufacturers!

 

So yes, one generic may be a shoddy product when compared to another generic. All pills are supposed to have 100% of the drug they say they have. But if the manufacturing process is not very good, you could get iffy pills. Mixing powders together is a very inexact science. And especially with the stronger benzos (alprazolam, lorazepam, clonazepam) where the pills my have as little as 0.5 mg drug in them, compared to the entire weight of the tablet at 150 mg or so, then you're talking about 0.3% of the tablet has drug in it. The manufacturing process needs to be really consistent. And a generic manufacturer just wants to make pills as cheaply as they can. They don't want to spend the money to make their manufacturing process as good as it can get. Of course, if some pills have a lower amount of drug in them than what they say they have, other pills in the batch will have a higher amount of drug in them. A batch of tablets for commercial distribution is at least 250 kg. If the tablets are 0.3% drug, that means the batch has 0.75 kg of drug in it. 0.75 kg drug mixed around in 250 kg. That's like half a teaspoon of sugar in a pound of flour. How well can you mix that together?

 

My own experience switching generics for my alprazolam... I went from Accord to Activis with no problem. The pills were the same color (pink) but different shapes (round vs oval). Then I was switched to a yellow football shaped tablet and all hell broke loose! It was like I had suddenly completely stopped taking the pills altogether. I had to up my dose, which was really disappointing. Now I'm back on Activis, and all is right with the world again.

 

Goodness I've droned on...

 

Good info Hope!

 

I think this is a real key takeaway:  "...Mixing powders together is a very inexact science. And especially with the stronger benzos (alprazolam, lorazepam, clonazepam) where the pills my have as little as 0.5 mg drug in them, compared to the entire weight of the tablet at 150 mg or so, then you're talking about 0.3% of the tablet has drug in it. The manufacturing process needs to be really consistent. And a generic manufacturer just wants to make pills as cheaply as they can. They don't want to spend the money to make their manufacturing process as good as it can get. Of course, if some pills have a lower amount of drug in them than what they say they have, other pills in the batch will have a higher amount of drug in them..."

 

we're counting on an extremely consistent and accurate process or some pills in the batch could be off from the others (as much as 20% in a given pill!)  Definitely some producers will be better at this than others.

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For community members who want to take a deeper dive into the issue of drug quality, here are links to two recent articles and a review of “Bottle of Lies” (a book about how some generic drug makers ignored safety and committed fraud):

 

Cheap Prescription Drugs in U.S. Can Have Hidden Cost - Bloomberg

https://www.bloomberg.com/news/features/2019-01-29/america-s-love-affair-with-cheap-drugs-has-a-hidden-cost

 

How Tainted Drugs Reach Market And Make Patients Sicker - Kaiser Health News

https://khn.org/news/how-tainted-drugs-reach-market-make-patients-sicker/

 

'Bottle Of Lies' Exposes The Dark Side Of The Generic-Drug Boom - NPR

https://www.npr.org/sections/health-shots/2019/05/12/722216512/bottle-of-lies-exposes-the-dark-side-of-the-generic-drug-boom

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Thanks Guys..

 

I stand corrected, -“IT” could be the actual med component.. :)

I just wish we knew for sure, in each case, then we could suggest updosing as a solution with a degree of accuracy...  Pity people dont notice the pills that the “extra” med is in..!!

 

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Pity people dont notice the pills that the “extra” med is in..!!

 

That's an interesting point, cant. I guess we would just feel . . . good? Normal? And attribute the normal feeling to our tapers not making us feel so G**-awful that particular day?

 

But I wonder. If these sub-par generics manufacturers are actually intending to save money by shorting us on active ingredients (or doing a shoddy job of measuring) chances are they're erring on the downside and not the upside. Just a thought. Yeah, I have a nasty, suspicious mind.  :-\

 

Katz

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For community members who want to take a deeper dive into the issue of drug quality, here are links to two recent articles and a review of “Bottle of Lies” (a book about how some generic drug makers ignored safety and committed fraud):

 

Cheap Prescription Drugs in U.S. Can Have Hidden Cost - Bloomberg

https://www.bloomberg.com/news/features/2019-01-29/america-s-love-affair-with-cheap-drugs-has-a-hidden-cost

 

How Tainted Drugs Reach Market And Make Patients Sicker - Kaiser Health News

https://khn.org/news/how-tainted-drugs-reach-market-make-patients-sicker/

 

'Bottle Of Lies' Exposes The Dark Side Of The Generic-Drug Boom - NPR

https://www.npr.org/sections/health-shots/2019/05/12/722216512/bottle-of-lies-exposes-the-dark-side-of-the-generic-drug-boom

 

thx for posting all these links and especially the 3rd one.  :smitten: i love the book "Bottle of Lies" and especially this section from the review:

 

People outside the FDA began noticing problems with generic drugs too. Eban documents growing skepticism toward some generics among doctors in the U.S. and Africa. After numerous cases in which patients experienced problems after switching from brand-name drugs to generics, many medical professionals began avoiding prescribing certain generic drugs.

Some patients who switched to a generic version of Wellbutrin, an antidepressant, complained of headaches, nausea, irritability and even suicidal thoughts. There were reports of pills that literally smelled "fishy." It took the FDA five years to verify that the generic pills produced by the Israeli manufacturer Teva were not equivalent to brand-name Wellbutrin.

 

The situation was even worse in Africa, where many manufacturers shipped their lowest-quality drugs. Some were completely counterfeit, with independent lab analysis showing no active ingredients whatsoever. Those that had active ingredients often didn't have enough, and doctors would need to prescribe anywhere from double to 10 times the typical dose to achieve an effect, according to Eban.

 

Eventually, Ranbaxy, as a company, was brought to justice. But none of the individuals responsible were prosecuted. Many Ranbaxy executives simply brought their expertise to other major generic-drug manufacturing companies, where fraud allegedly continues, as Eban documents further in her book.

 

Eban emphasizes that when generics work, and many do, they serve a vital role in public health. But her work has exposed the deep challenges of regulating a globalized pharmaceutical industry. She ends the book on a maddening note, saying that after a brief stint of conducting unannounced overseas inspections from 2014 to 2016, the FDA went back to notifying plants of routine inspections well in advance. The FDA's Woodcock told NPR that the agency focuses its global inspection efforts on "higher-risk facilities" and said that "over the past several years we conducted a number of unannounced inspections."

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I've read some of this information before. It's downright terrifying. And given that I suffered significant s/x from a generic cardiac med that did not have an adequate am't of active ingredient in it, I can attest to this phenomenon firsthand.

 

I'd forgotten the titles of those books. Thanks for posting them, Libertas.

 

People who believe all generics are the same, and safe, really ought to read one of them and stop gaslighting the folks on here who state that they experience s/x from a change in generic.

 

Katz

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https://youtu.be/zbvKS7yryhg

 

this shows how many steps are involved in pill making, and how difficult it actually is to assure accuracy/consistency in API becomes more evident

 

https://youtu.be/tazn5kUDHMU a happy go lucky good feels promotional video to assure us that mylan is on our side  (  ;D ) "mylan's morgantown plant routinely produces more than 16 (or 60? couldn't hear that part well) MILLION pills per day!"  so i wonder how accurate the pill content of API is with that many being pushed out a day? wonder what the margin of error is? this vid is from 2015.

 

as far as i can tell, these processes all involve a human being scooping scraping or dumping a bunch of fine powder into a big vat with a shiny screw shaped dough mixer thing and then it further mills and grinds or moulds the mixture into the final tiny pills we're familiar with.  so yeah i like the analogy of mixing a tiny amount of powder into a big thing of flour. even with machinery in 2019, the tiny grains get stuck to each other, to machine parts, in cracks, and even whiffed up into the air as shown in one video...there's so many places for errror. how could a generics manufacturer trying to cut costs on labour and "parts" or machinery possibly come out with evenly dosed pills especially in the light of their lax FDA/regulatory  inspections? i keep seeing the image of two businessmen passsing fat envelopes of cash under the table between them and nodding their solemn "i won't tell if you dont"s to each other...lol funny not funny!

 

 

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People who believe all generics are the same, and safe, really ought to read one of them and stop gaslighting the folks on here who state that they experience s/x from a change in generic.

 

thank you!  :thumbsup:

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https://youtu.be/zbvKS7yryhg

 

this shows how many steps are involved in pill making, and how difficult it actually is to assure accuracy/consistency in API becomes more evident

 

 

 

Oh my gosh watching that brought back memories! The company I worked at always used the wet granulation process because of the type of extended release tablets they made. In fact they were just starting to look into the roller compaction process when Johnson & Johnson (who had bought the company 5 years before) decided to shut down the facility and lay everybody off.

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because of insurance they always give me the generics the insulin needles are awful they don't want to go into my skin and they make me bleed 
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because of insurance they always give me the generics the insulin needles are awful they don't want to go into my skin and they make me bleed

 

That really sucks, I am so sorry  :(

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because of insurance they always give me the generics the insulin needles are awful they don't want to go into my skin and they make me bleed

 

ouch kachina  :therethere:  was it the burrs on the metal? that sux

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https://youtu.be/zbvKS7yryhg

 

this shows how many steps are involved in pill making, and how difficult it actually is to assure accuracy/consistency in API becomes more evident

 

https://youtu.be/tazn5kUDHMU a happy go lucky good feels promotional video to assure us that mylan is on our side  (  ;D ) "mylan's morgantown plant routinely produces more than 16 (or 60? couldn't hear that part well) MILLION pills per day!"  so i wonder how accurate the pill content of API is with that many being pushed out a day? wonder what the margin of error is? this vid is from 2015.

 

as far as i can tell, these processes all involve a human being scooping scraping or dumping a bunch of fine powder into a big vat with a shiny screw shaped dough mixer thing and then it further mills and grinds or moulds the mixture into the final tiny pills we're familiar with.  so yeah i like the analogy of mixing a tiny amount of powder into a big thing of flour. even with machinery in 2019, the tiny grains get stuck to each other, to machine parts, in cracks, and even whiffed up into the air as shown in one video...there's so many places for errror. how could a generics manufacturer trying to cut costs on labour and "parts" or machinery possibly come out with evenly dosed pills especially in the light of their lax FDA/regulatory  inspections? i keep seeing the image of two businessmen passsing fat envelopes of cash under the table between them and nodding their solemn "i won't tell if you dont"s to each other...lol funny not funny!

 

And the brands do the same scooping and scraping.

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Oh my gosh! This is so comforting to read. They switched the manufacturer of my Klonopin last year and that's when my anxiety and depression got worse. I fully believed it was the switch, but nearly everything I read online said you wouldn't notice a difference. That's when things really started going downhill, and then they c/t me.
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Oh my gosh! This is so comforting to read. They switched the manufacturer of my Klonopin last year and that's when my anxiety and depression got worse. I fully believed it was the switch, but nearly everything I read online said you wouldn't notice a difference. That's when things really started going downhill, and then they c/t me.

I sorry to hear...

-Thanks for posting, it highlights the potential seriousness of this..

Small consolation though, I know...

:(

 

***

Hey katz

I think your probs right, all things considered, it would be a mistake to assume one would notice the UP as much as the DOWN, -perhaps because DOWN is the boundary we are pushing against..?? And I suppose our bodies are also designed to warn us of negative situations more efficiently than they might for more “rewarding” situations..?? (In the most basic of speculations.. lol)

 

Will try to watch those links tomorrow, as I had often wondered how things were done..

 

:)

 

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Heather,

I was on Temazapan for 25 years. DOSE-variation would be from 7.5 to 15. The last five years of taking it, I would have multiple mystery illnesses. One right after the other. No answers no resolution but I always felt horrible. April 2016 I was having stress and upped my dose to 30mg. By June 2016, I was in severe withdrawal. Temazapam is a different animal from the other Benzos . I was given false security that it was a “low potency “ benzo. It a bad bad drug. In Sept if 2016, I crossed over to 11 mg of Valium and began the taper in October. Now, 3 years later, I am at 2 mg. I had to go very slow due to life events.

 

In summary, maybe this is a sign that it is time to begin a taper from this drug.

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