Posted on 09/16/2019 11:37:47 AM PDT by CondoleezzaProtege
If you’re a layperson, this is the way you probably think of generics: They’re the exact same products in different packaging...
In October the Food and Drug Administration took a highly unusual step: It declared that a generic drug it had previously approved — a version of the popular antidepressant Wellbutrin — was not in fact “bioequivalent” to the name-brand version. The FDA withdrew its approval.
...Generic drugs diverge from the originals far more than most of us believe. For starters, it’s not as if the maker of the original pharmaceutical hands over its manufacturing blueprint when its patent runs out or is challenged. The patent reveals the components, but it doesn’t explain how to make the drug. In reality, manufacturing a generic requires reverse engineering, and the result is an approximation rather than a duplicate of the original.
The FDA’s rules effectively acknowledge that. The agency’s definition of bioequivalence is surprisingly broad: A generic’s maximum concentration of active ingredient in the blood must not fall more than 20% below or 25% above that of the brand name. This means a potential range of 45%, by that measure, among generics labeled as being the same.
There are other differences. The generic must contain the same active ingredient as the original. But the additional ingredients, known as excipients, can be different and are often of lower quality. Those differences can affect what’s called bioavailability — the amount of drug that could potentially be absorbed into the bloodstream. As the American Heart Association recently noted, “Some additives traditionally thought to be inert, such as alcohol sugars, cyclodextrans, and polysorbate-80, may alter a drug’s dissolution, thereby impacting its bioavailability.”
That can result in drugs that release active ingredients into the blood far more quickly, leaving patients feeling dizzy or nauseated.
(Excerpt) Read more at fortune.com ...
Not sure where in the states you are located, but international supermarkets are likely to carry it, both pre-made (and without additives) or the necessary ingredients. Asian markets...as well as Latin, etc...
“And it wouldn’t be a surprise. Judging even from the few responses here though, for now it does seem to be safer to err on the side of a brand-name version when it comes to prescription drugs.”
I’d disagree. The regulation is such that the equivalence will be great.
“But over the counter items...or even supermarket-brand food items, there is more room for flexibility and may even be preferable to brand-name.”
Yes. Not the same regulations at all. Ice cream, for example, doesn’t have to be equivalent. I like store brands as much or more than the more costly big names.
Regarding generic drugs, I’ll point out what I think is the bottom line. I don’t know if this article addressed it.
If a generic is different than a brand name, then the regulatory process failed.
Asian markets where I live (as many if not more than Anerican) sell bones specifically for it.
I’ve seen the packaged bone broth at Vons which is Safeway.
Aspirin = acetylsalicylic acid
Bayer Aspirin = acetylsalicylic acid
Rite Aid Aspirin = acetylsalicylic acid
CVS Aspirin = acetylsalicylic acid
Walgreen’s Aspirin = acetylsalicylic acid
You’re Scottish?
Bayer Aspirin = acetylsalicylic acid
Rite Aid Aspirin = acetylsalicylic acid
CVS Aspirin = acetylsalicylic acid
Walgreen’s Aspirin = acetylsalicylic acid
OKAY. So if you really want to get into it...I trust GERMAN-made products more than most, and BAYER is a German brand.
I recently found out that Bayer's Alka Seltzer antacid tablets sold in most U.S. stores is now made in Mexico! SO...I've chosen a drug-store alternative that to my knowledge is U.S. sourced.
These kinds of things make a placebo difference to be sure, but sometimes it's a genuinely valid distinction!
Bone broth == GOOD STUFF, regardless of the source animal.
The Soviet Lada was a generic Fiat 124. If forced to drive one or the other, which would you choose?
I can’t take ibuprofen or any other NSAIDs. I’m stuck with Tylenol which is not kind to my digestive system.
Doc won’t prescribe tramadol any more and actually suggested I try medical mairjuana, even though he wouldn’t prescribe it. I don’t think it would help my pain, but I don’t know. I do believe it would help stimulate my appetite and alleviate my nausea, and I actually made an appointment with a doctor for Friday who will. Just have to prove I have arthritis. Strange, because recreational cannabis is legal in Michigan, but not available yet. It won’t be until sometime in 2020. I’ve lost a lot of weight in the last few months. I’m 5’ 11” and down to about 150 lb. Most of my adult life I carried 180-185 lb.
Fair question. He does have red hair.
All over his body.
I said in an earlier post that over the counter considerations are different from prescription. But other things need to be taken into account.
Someone just pointed out that all aspirin is the same regardless of the brand...but once I found out Bayer Alka Seltzer (a German brand) was not made in Germany, but Mexico...I switched to a generic version made in USA.
RRe:”generics have from 80% to 120% of the active ingredient in their offering.
be aware.”
Not to mention different inactive ingredients to which you can react badly or which can change how your body absorbs the medication.
Then there are narrow window medicines where +20% could cause very serious reaction, including death.
And the Fiat 124 has the same basic design as the Lada 1200.
Both will usually get you where you’re going, I bet the Fiat is a little more comfortable, and the Lada more robust.
It’s just a question of whether you prefer the assembly being done by someone drunk on Italian wine, or Russian vodka...
Oh my! I am SO sorry that the mainstream NSAIDs won't work. Regarding Tylenol, have you tried different incantations? Like, instead of the white-coated pills (which I can't handle either) but trying the quick-release gelcaps or liquid gelcaps instead?
I've never heard of Tramadol, but I'm assuming your doctor's reluctance is a good sign and has to do with the opioid madness that's descended upon the country.
Re: marijuana. I'm selfishly skeptical of as it's 'medical' usage has provided the gateway for recreational use that I am often the secondhand or thirdhand smoke recipient of here in cannabis-crazy Los Angeles. :(
I am sending prayers your way, but I honestly believe that CHRONIC pain necessitates treatment that addresses UNDERLYING causes and not just symptoms. It also needs to address things like the impact of mental stress on the body. A holistic approach that also includes dietary and exercise changes.
And this is where I hope you can find access to (affordable) professionals in the Chiropractic field for example. Or Acupuncture, Physio, and Massage therapy. Also nutritionists.
The problem is when the brand-name sticks even when the product quality has gone down. (Like Boeing, which has outsourced much of its manufacturing.)
Vodka fueled assembly...
You bet there’s a difference! I’ve been on Synthroid since 1992.
The generic Levythyroxin absolutely kills me.
10 years ago my then Doc INSISTED I go on generic for 6 months and I ended up losing the best job I ever had because I couldn’t think clearly and was unable to handle stress as usual. I was also unable to sleep and tired all the time.
My pharmacy has filled the generic instead of name brand a few times and I’ve tried taking it with the same results. Walking death.
My condition is Secondary Hypothyroidism after having a pituitary tumor so maybe that makes some difference, but I am not alone in my assessment of the generic being crap.
And you - Generic Defender Guy on this thread - don’t even bother.
And for you other Synthroiders, here’s an article:
WHAT ARE THE IMPLICATIONS OF THIS STUDY?
This study demonstrates that Synthroid and generic levothyroxine are not equal in children with congenital hypothyroidism, even though the FDA states they are interchangeable.
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