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Re: Nardil from Australia = 1950's version.JV

Posted by djmmm on April 13, 2004, at 20:56:59

In reply to Re: Nardil from Australia = 1950's version.JV, posted by Spotcheck on April 13, 2004, at 16:14:50

> "that's not true...I took Nardil (the "older" version) for a few years..was off it, and have been back on the "new" Nardil for a few months. Other than the HORRIBLE "plastic/glue" taste, my dosage of 60mg has been count me as, apparently, the only one that DOESN'T notice an efficacy difference...."
> All right, but you are still an exception, not the rule so far that is. I have no statistics on how many old Nardil customers respond to the new Nardil. Only that would really tell us the story. Nevertheless, I will not retract my statement that everyone would prefer the old Nardil even in you case since you find the tastes to be an irritant. I have heard if from others but it doesn't bother me at all. Nevertheless, I agree, that this can happen. I have just found it be rare.
> "I think that a select few people have created this non-effective Nardil "hysteria" and it has spread like wildfire (through that OTHER med forum) I do miss that orange candy
> GOD does the newer Nardil taste bad."
> If this is what you think, then in my estimation alone, you know relatively little about medication pharmacology especially in tablet form. You see what really determines how any active ingredient, like phenelzine sulfate, is metabolized is not the phenelzine sulfate, djimm. The excipients or inactive ingredients that accompany the active ingredient do that.

Im not an idiot. I am aware of the role of inactive ingredients.

Otherwise, I should be to take straight Phenelzine Sulfate, put it in a glass of water (guess what? It will not even dissolve uniformly in H20 in my experiments) and you could drink that down, and it work just like the old Nardil. Well, sadly that is not the case my friend.

--Then you are a poor chemist..phenelzine sulfate dissolves readily in water (Evidence for carcinogenicity to animals)IARC Monographs, 24, 175-184, 1980

> Consider this well: of the 15 original excipients in old Nardil, which I can and will enumerate if necessary, only 3 remain the same in the new Nardil, and the number of excipients dropped to 9 in the new Nardil as well. When a generic drug is made, there is no telling how well it will be metabolized.

--You may not have an accurate grasp of the role of inactive ingredients, or the role of the FDA (when a drug formulation has changed)

Did you not read KV's post to SuzyQ1 about the same problems in Tofranil, I believe, he said? Therefore, when Pfizer made this change, she was virtually guaranteeing that some small percentage of customers would not metabolize it well -- if at all and that is indeed the reality of this situation.

--I just don't believe that...It doesn't make sense..for a company to change inactive ingredients, then inform the consumer that in some people the medication will not work at all... does this make sense to you??

> If I had a laboratory that was well equipped, I could make a generic Phenelzine that was in vitro bioequvalent to the old Nardil and so would pass the FDA under the ANDA = Abbreviated New Drug Application, which requires no animal or human trials, that your body would not metabolize.

--That just isn't the entire truth...true with an ANDA, you must demonstrate bioequivalence. The easiest and most common way to do this is with a specified number of HUMAN volunteers. The FDA requires that even ANDA generic meds must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the original patent drug(Waxman-Hatch Act)...regardless of the inactive ingredients. The "new" Nardil was subject to the same strict guidelines as any other drug.

I actually already did with my H2O example. Then, we would see for yourself if your hypothesis of hysteria above is correct or incorrect.

--well since you failed to dissolve phenelzine sulfate in water...

Yes, would be in rough shape exactly as these people are. So please do not make such rash assumptions henceforth, all right?

--I have read the original threads (on a different site) and I can also recall several completely ridiculous statements, one of which claimed that the "new" nardil was Phenelzine HCL, not sulfate...and this ridiculous fallacy was repeated several times in various threads, and believed to be the truth by many.

--FWIW, it is hysteria...drug companies change inative ingredients all the time. What manufacturer would mass produce a medication that is inferior to an older version? What manufaturer would waste millions of $$ in research/development and RISK not only their reputation, but the mental health of ten's of thousands of it's consumers?

--There is NO Nardil conspiracy, and no amount of bombastic, pseudo-scientific jargon will ever convince me otherwise.

> Dr. Bob, I apologize in advance if you think the tone of this post is too antagonistic. It is my intention to explain something important to this individual in particular and also to drive home with an example that would create this effect him him/her. Chastise me if you must.

--LOL..don't worry, no offense taken here..and that's what matters, right?




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