What Is Your View on Generic Drugs?

[mick]

What's your view on generic drugs?

Over the past week or so I have experienced an very big spike in my T volume. I suspect it may be from the new prescription I got for escitalopram. I've been taking it since my T started and have always got it from the same pharmacy until this time. The pills I got this time were made by a different manufacturer, and my body does not react the same to them as the other ones I've been taking - not only has my T increased, but these new pills make me nauseous and restless.

I work for a generic drug manufacturer, so I know the pitfalls of making generics. Despite all the stuff you read, generics drugs are not 100% the same as the non-generic or even generics from manufacturer to manufacturer. The only thing the manufacture must validate is that the active molecule is the same. All drugs have fillers and contaminants. There are specifications for the level of contaminants, and I can assure you the spec is not 0.00000%.

Where I work we make multiple drugs in the same chemical manufacturing line (one week it might be product Y, the next week product X). This is pretty typical for generic drug manufacturers, particularly if their production volume is low. The equipment is cleaned between different product campaigns, and of course we follow all FDA regulations and must document that the process is sufficiently clean (this is usually done by analyses the final rinse water). I have always asserted that while the process may be cleaned to specs there is no way that it is pristine and 100% free of drugs from the previous manufacturing campaign. There are lots of places that chemicals accumulate that are hard to clean - valve packing, crevices at pipe joints and in equipment internals, bolt threads on agitator blades, etc. So I believe trace amounts of all the drugs made in that production line end up in each of the drugs made there. It's a reality that is overlooked by doctors and those who say generics are identical.

Furthermore, there is no requirement that generic drugs be made by the same process as the original. This means that an entirely different chemical pathway can be used and as a result the side reactions can produce entirely different contaminants as the chemical pathway used by the orginal manufacturer. Again, I have little doubt that the level of contaminants made by different side reactions is within the specifications, but that doesn't mean the contaminants are zero.

Lastly, taking a non-generic does not protect you from the presence of trace amounts of other medications in the the one you buy. Generic manufacturers often make the active ingredients for brand name medications, and brand name manufactures sometimes make multiple products in the same production line. The highest volume products are the ones that are least likely to have cross-over contamination because the production line will tend to be dedicated to the one product.

Of course this issue does not just apply to prescription drugs. It applies to over-the-counter drugs, and supplements as well.

What have been your experiences with generic drugs? Have you ever taken the same drug made by different manufactures and sensed different side effects, or felt like they were not working the same?

 

[Karen]

Hi, Mick,
I would like to comment on this, as I have been taking a prescription drug for many years, Synthroid, which is very common. My body is well adjusted to it, and I don't have any real side effects from it. A couple years ago, my pharmacist happened to be out of the Synthroid at the time I needed it, and asked if I would like to try a generic. I said yes ---- and regretted my decision. The generic made me feel dizzy and lightheaded, and I felt totally off-kilter. I only took it for about 3 or 4 days, but it took a week or so for my body to get back to normal, with no vertigo, after that experience. From then on, I've made sure that I receive the name-brand drug from the pharmacist.

Also, the reason I have severe tinnitus today, I believe, is that I took a generic blood pressure drug. It caused me many bad side effects, both during the time I was taking it, and after I got off the drug. I've since read that others have had a problem with the same drug from that particular manufacturer. How I wish I had known that beforehand!

So, in response to your question: Yes, I can definitely say that the generics I've used have not been the same, and have caused different side effects. I'll be interested to hear others' comments about generics. Thanks for posting this topic!

 

[Fish]

Thank you Mick, that was an interesting read!

I am a bit shocked with what you wrote, I always thought generic drugs have to be 99.9% the same as the original and not only the active compound. I also thought in case of drug manufacturing, the equipment would always be perfectly clean, free of any contamination. I can imagine in very unfortunate circumstances, taking a generic contaminated with particles from the previous drug could probably even kill somebody.

I must say I use generic drugs very often. I've been taking betahistine for over 5 months to treat my tinnitus (I believe it really works and everyone should try it!) and the original drug, "Betaserc" is really expensive compared to it's cheaper generic, "Vestibo". I used both of them and I felt both work for me.

 

[mick]

Fish,

The odds are the drugs are 99.9% the same. It's the stuff in the 0.001% range and lower that I'm talking about. I'm not trying to scare anyone - I think it would be unlikely that there would be enough of a cross-contaminant to kill someone unless they were extremely sensitive to it, but it would not surprise me if it has happened (lots of drugs, lots of people taking them almost makes it inevitable that it has happend at least once). I suspect no one would ever pick up on it though. It would probably be a mystery death.

Note also, that the product specs usually include maximum concentrations of specific dangerous compunds that are expected to be made in the process. So if they know that compound A could be made as part of the chemistry, and compound A is a health concern, the analysis specs will call that out specifically (can not have more than X% of A). It is not just a max spec for all contaminants combined.

The other part of the story is, as you might expect, you can't test every bit of product you make. Samples are taken and analyzed, but sometimes a sample may not representative of the whole batch. You could feasibly have some product from the previous run caked up in the top of a dryer (you shouldn't; it is inspected, but people are fallible), but if the chunk of product falls on to the desired product and it looks the same, it may not be noticed and may not be captured by the sample. They usually take several samples at several parts of the process and from the finished goods, but its still not everything. It's not a perfect manufacturing process, sampling is not perfect, and mistakes are made. Fortunately, not often or we probably would hear of more problems.

Lastly, I don't want to get myself in trouble so I will avoid specifics, but we make the active ingredient for a high volume over-the-counter medication that you have probably taken. The process produces different grades of that product just because it is not a perfect process. Some days things run better than others - maybe fewer contaminants, maybe a better color, or smell. It could be any characteristic. We sell that product to brand name sellers and generic sellers. Who do you think has the tighter specifications for the the active ingredient and who to you think gets the higher grade stuff? The customer paying the highest price or who takes the highest volume gets the best stuff (gonna treat your best customers the best). That is typically the brand name seller because he can sell it for a higher price. I'm not saying there is a serious difference between the grades, but there is a difference.

mick