Psycho-Babble Medication Thread 283363

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Nardil and Selegline

Posted by Strat on April 10, 2004, at 21:47:24

In reply to Re: Nardil from Australia = 1950's version., posted by Spotcheck on April 9, 2004, at 22:49:56

Hello, all! I do wish some of you would come over and post on the other anxiety board; Spotcheck, you sound very knowledgeable, we could all use your input. We've all filed MedWatch forms, called Pfizer and done what we can to get attention. Won't you please stop by there, as well?

http://www.anxietyhelp.org/treatment/medication/nardil.html

Thanks!
Strat

 

Re: Nardil from Australia = 1950's version.KV » Spotcheck

Posted by King Vultan on April 11, 2004, at 10:58:01

In reply to Re: Nardil from Australia = 1950's version.KV, posted by Spotcheck on April 10, 2004, at 20:25:24

Sorry if I came across as unsympathetic, as I think it's extremely unfortunate that so many people have suffered as a result of the Nardil formulation change. However, it is true that the number of people taking Nardil is tiny compared to the number taking Zoloft, for example. Having some experience with the way high and low volume compounds are differentiated and also some familiarity with the way big companies think, I think it's likely that the reformulation was done with less care than it should have been.

For the people who have been negatively affected by the formulation change, all I can suggest is to increase dosage and attempt to find a level, which hopefully actually exists, that will provide the same efficacy as did the former dosage of the old formulation. Everyone is agreed that the active ingredient, phenelzine sulfate, is unchanged and still in the pills, and my conclusion is that it's a very similar issue as the imipramine matter I referred to in my other post--the absorption rate has changed for those negatively affected by this, and not as much Nardil is actually making it into people's systems. I don't know if the old maximum dosage of 90 mg/day still holds true, but if I were someone who had successfully been on this drug for years, I think the reasonable and prudent thing to do would be to start increasing dosage and communicate with other affected users as to the results.

I do think Pfizer should be taking the complaints into account and informing doctors and pharmacies about the formulation change and its potential ramifications. I guess that's too much to expect from a big corporation, though.

Todd

 

Re: Nardil from Australia = 1950's version.KV » King Vultan

Posted by Spotcheck on April 11, 2004, at 13:50:59

In reply to Re: Nardil from Australia = 1950's version.KV » Spotcheck, posted by King Vultan on April 11, 2004, at 10:58:01

That's just the problem though Todd. These people do not respond to the new Nardil no matter what dosage level the choose. They can push the dosage as high as 120 mg and still not get enough Phenelzine Sulfate dissolved in the fats of their nervous system to help them at all.

Furthermore, it is quite true that Pfizer began having potency problems with the old Nardil. If you run a search on this problem you will find the exact dates and lots that she had to pull. So what began happening is that people would be dispensed Nardil, but their symptoms would return because the Nardil that they were taking was no longer potent enough to do them any good. In the end, I suspect the decision was made to continue producing Nardil, but to change the excipients from 15 in the old to 9 in the new only 3 of which remained the same. Hence, the new Nardil never was going to be metabolized by as many people due to the number of changes made here. That still might well have been the best Pfizer could do -- if they could not straighten out their manufacturing problem.

They will happily take your complaints, but they cannot do a bloody thing about them, so to complain is virtually worthless.

My recommendation would be then to prescribe either Parnate or Venlafaxine (EffexorRX) since Venlafaxine is the most balanced of the SNRIs out there and is a potent reuptake blocker of BOTH 5HT and NE that has a long half-life. Then, I would recommend people hang on using one of these two medications, and any other adjunct medications that worked well with them, until the FDA finally passes the Selegiline Patch called EMSAM which is manufactured by Somerset Pharmaceuticals that SuzyQ1 mentioned above. That rascal will increase brain concentrations of 5HT, NE and DA -- which is almost exactly what Nardil does, although not quite. Phenelzine Sulfate with the proper excipients or when it is also properly metabolized also increases the brain concentrations Gamma Amino Butyric Acid (GABA) which I have long suspects helps people cope with anxiety disorders.

Todd, I never did mean for you to think that I thought you were insensitive to this issue at all. I just think your explanation about this entire Nardil mess is incorrect as to why Pfizer actually did change Nardil. I think she pretty much had no other choice except to stop producing it entirely.

And of course I have gotten together was a flock of Nardil uses who are having problems with the new Nardil, and we attempt to keep each other going and figure out solutions to this problem in particular. Come visit us at the Anxiety board since this is pretty much all we do talk about.

You can find the link in Strat's post, in fact, if you wish to visit. If you can think of any thing else that can be done though kindly post something about it, will you please?

Thank you very much for replying to this post.

Dave

 

Re: Nardil from Australia = 1950's version.KV » Spotcheck

Posted by King Vultan on April 11, 2004, at 17:04:57

In reply to Re: Nardil from Australia = 1950's version.KV » King Vultan, posted by Spotcheck on April 11, 2004, at 13:50:59

I quite agree that either Parnate or Effexor would be the drugs to go to for those for whom the Nardil is unfortunately no longer effective. I'm curious as to whether you have an estimation as to what percent of Nardil users have been negatively affected by the formulation change. Are there some people who have not noticed a difference?

Thanks,
Todd

 

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

Posted by Spotcheck on April 11, 2004, at 18:45:38

In reply to Re: Nardil from Australia = 1950's version.KV » Spotcheck, posted by King Vultan on April 11, 2004, at 17:04:57

I do not have any statistic -- yet -- that would tell me what percentage of Nardil users fail to respond to the new Nardil. Pfizer might have some of course, but I don't. I have run across about 10 people, but I suspect there are more. One has been able to move to Lamictal -- an atypical antidepressant. For some Parnate does not work on them at all, while in others it helps them only somewhat. However, it definitely does not work as well as the old Nardil did by anyone's standards.

When the new Nardil does not work or begins to fade and actually fails, it's a tragic event to witness, let me tell you. My heart drops whenever I read someone's post to that effect. In SuzieQ1's post, I suspect that all she really has to do is increase the dosage and she will be just fine. She is expecting the new Nardil to work as well as the old Nardil did which is a common mistake.

"Are there some people who have not noticed a difference?"

Everyone has noticed a difference Todd, and everyone would much rather be taking the old Nardil rather the the new. Only those who have never taken the old before cannot know the difference. For the most part we have all had to increase the dosage we take of the old to achieve a similar effect.

 

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

Posted by djmmm on April 13, 2004, at 12:52:20

In reply to Re: Nardil from Australia = 1950's version.JV » King Vultan, posted by Spotcheck on April 11, 2004, at 18:45:38

> I do not have any statistic -- yet -- that would tell me what percentage of Nardil users fail to respond to the new Nardil. Pfizer might have some of course, but I don't. I have run across about 10 people, but I suspect there are more. One has been able to move to Lamictal -- an atypical antidepressant. For some Parnate does not work on them at all, while in others it helps them only somewhat. However, it definitely does not work as well as the old Nardil did by anyone's standards.
>
> When the new Nardil does not work or begins to fade and actually fails, it's a tragic event to witness, let me tell you. My heart drops whenever I read someone's post to that effect. In SuzieQ1's post, I suspect that all she really has to do is increase the dosage and she will be just fine. She is expecting the new Nardil to work as well as the old Nardil did which is a common mistake.
>
> "Are there some people who have not noticed a difference?"
>
> Everyone has noticed a difference Todd, and everyone would much rather be taking the old Nardil rather the the new. Only those who have never taken the old before cannot know the difference. For the most part we have all had to increase the dosage we take of the old to achieve a similar effect.

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 fine....so count me as, apparently, the only one that DOESN'T notice an efficacy difference....

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 coating...my GOD does the newer Nardil taste bad.

 

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

Posted by Spotcheck on April 13, 2004, at 16:14:50

In reply to Re: Nardil from Australia = 1950's version.JV, posted by djmmm on April 13, 2004, at 12:52:20

"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 fine....so 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 coating...my
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. 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.
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. 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.

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. I actually already did with my H2O example. Then, we would see for yourself if your hypothesis of hysteria above is correct or incorrect. Yes, would be in rough shape exactly as these people are. So please do not make such rash assumptions henceforth, all right?

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.

 

Re: please be civil » Spotcheck

Posted by Dr. Bob on April 13, 2004, at 20:41:15

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

> If this is what you think, then in my estimation alone, you know relatively little about medication pharmacology

> 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.

Please don't post anything that could lead others to feel accused or put down. It's possible to explain things without doing that.

If you have any questions or comments about this or about posting policies in general, or are interested in alternative ways of expressing yourself, please see the FAQ:

http://www.dr-bob.org/babble/faq.html#civil

or redirect a follow-up to Psycho-Babble Administration.

Thanks,

Bob

 

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 fine....so 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 coating...my
> 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?

 

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

Posted by Spotcheck on April 13, 2004, at 22:48:10

In reply to Re: Nardil from Australia = 1950's version.JV, posted by djmmm on April 13, 2004, at 20:56:59

djimm:

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 coating...my
GOD does the newer Nardil taste bad.

Spotcheck:

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.

djimm:

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

I never called you an idiot djimm, because I simply would not do that.

Spotcheck:

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.

djimm:

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

Well done, and I stand corrected. It does dissolve much faster in ethyl alcohol though even though this does not erase my error.

Spotcheck:

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.

djmmm:

"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)"

That's entirely possible, I must confess. However, I would like to know more since I might well need the information. Can you direct me to a source that would better inform me?

Spotcheck:

"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."

djimm:

"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??"

djimm, they really don't inform anyone. The results I am talking about are empirical and based on people's experiences. In this particular case, I have allot of experience. What makes you think that any drug company announces it is changing to a generic drug? All they do is provide a package insert. That's all they have to do, in fact. In the case of new Nardil, they did not inform anyone -- not pharmacists and not doctors, and that's why this row began in fact.

Spotcheck:

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.

djimm:

"That just isn't the entire truth...true with an ANDA, you must demonstrate bioequivalence."

Exactly! That's precisely why it so easy to create generic using an ANDA. No animal or human trials are required. I can take you to the FDA and demonstrate this, if you would like.

"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."

First, I simply disagree with you about what is required to get a drug passed the FDA using an ANDA. That much I have researched, unless Waxman is more recent, and has not yet been posted to the FDA's website. Then, I would be in error.

However, that was never my argument with respect to Nardil, djimm, because Pfizer used what is called an SNDA -- Supplemental New Drug Approval, not an NDA nor an ANDA. It only requires limited human trials.

Spotty:

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

djimm:

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

It works much better in 200 proof ethyl alcohol. However, even if I was mistaken about the water, that does not rebut what I said here, and I suspect you know it too.

Spotcheck:

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

djimm:

--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.

Well, if you are referring to a site both of have read then I agree, but the truth is that in tablet form, Phenelzine Sulfate is always used. So, I have no problem with you statement, since I agree.

djimm:

--FWIW, it is hysteria...

Spotcheck:

I wish that was true, djimm. I really do wish that was the God's honest truth, because nothing would please me more. Unfortunately, it is not the truth and I need to prove this then let us agree right here and now to get in touch via e-mail and I will prove it to you. You can reach me at Twinoppose@hotmail.com - if you wish.

djimm continued....

"drug companies change inative ingredients all the time. What manufacturer would mass produce a medication that is inferior to an older version?"

Whew, I can see that we really do need to talk somewhere else. However, at the risk of losing my neck here, they do not mean it to happen this way, djimm. It just does happen, because of the very role that excipients play in the metabolism of any complicated medication. I thought that I had made this abundantly clear in my first post in fact. If not, I am genuinely sorry that I did not better communicate my message.

djimm:

"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?"

Any company that faced this choice: either discontinue making a very old MAOI, that is rarely ever prescribed by a psychiatrist and almost never as the first medication, or produce a drug that was essentially a generic drug, which have been know to cause some people problems. Shoot it happened to me with one of the first generic Amitriptyline. I was taking Elavil, and I unknowing was prescribed a generic, and it simply did not work as well. I confirmed in myself a couple of times.

djimm:

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

Of course there is no conspiracy djimm, nor did I ever say there was about Nardil. I have never considered it a Conspiracy at all. What I did, say however, is that whenever you change the excipients of any medication, you very likely Will get some people who do not metabolize it. And that spells trouble.

Now, if you are genuinely interested in engaging ina more in depth look into this subject where we could both learn something then please e-mail me and we will discuss privately so that Dr, Bob does not have to be the Matador. Agreed?

Spotcheck:

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.

djmmm:

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

Absolutely! All I wish to do is better explain myself to you. Kindly contact me and we can do exactly that!

 

Redirect: questions and comments

Posted by Dr. Bob on April 14, 2004, at 1:12:31

In reply to Re: please be civil » Spotcheck, posted by Dr. Bob on April 13, 2004, at 20:41:15

> If you have any questions or comments about this or about posting policies in general ... redirect a follow-up to Psycho-Babble Administration.

Here's a link:

http://www.dr-bob.org/babble/admin/20040307/msgs/336193.html

Thanks,

Bob

 

Re: please be civil » djmmm

Posted by Dr. Bob on April 14, 2004, at 1:25:16

In reply to Re: Nardil from Australia = 1950's version.JV, posted by djmmm on April 13, 2004, at 20:56:59

> Then you are a poor chemist..

Please don't post anything that could lead others to feel accused or put down.

If you have any questions or comments about this or about posting policies in general, or are interested in alternative ways of expressing yourself, please see the FAQ:

http://www.dr-bob.org/babble/faq.html#civil

or redirect a follow-up to Psycho-Babble Administration.

Thanks,

Bob

 

Re: Redirect: questions and comments

Posted by Spotcheck on April 14, 2004, at 1:31:00

In reply to Redirect: questions and comments, posted by Dr. Bob on April 14, 2004, at 1:12:31

Thank your Dr. Bob.

I have asked the kind gentlemen to e-mail me, if he wishes to pursue this discussion any further, so there will be no more replies on your board from me, about this subject. If he wants to discuss this further, then he knows were we can do precisely that.

I am genuinely sorry to have caused you to have to step into the same thread twice. It will not happen again.

Spotcheck

 

Re: COMPAINTS REGARDING NEW NARDIL

Posted by SuzyQ1 on April 15, 2004, at 11:27:47

In reply to COMPAINTS REGARDING NEW NARDIL, posted by ace on November 24, 2003, at 18:59:51

I have increased my dose of Nardil from 30 mg. to 45, and after 4 days, am starting to feel a little better, but still very apprehensive. I also take Ativan with it, to calm down the dystonic side effects of Nardil. For me, it was tight throat muscles that made me feel like I had a lump in my throat. The Ativan takes care of that. I have no doubt that the new Nardil doesn't work as well as the old one, since my blood pressure suddenly shot up about 4 months ago. Nardil was apparently lowering my blood pressure, as a side effect, and that was a positive for me. My doctor couldn't understand why my pressure for the first time was elevated, and gave me water pills. I could have had a stroke on the new Nardil, since it was no longer as effective. On 3 pills/day, my pressure has started going back down. This is besides the terrible anxiety I got again, and the depression and crying that followed. I don't know how well the 3 pills/day will hold me, but I'm praying very hard. In the meantime, I called Pfizer and raised some hell about it. They seemed to take notes. I talked to a pharmacist as well as a Nardil specialist. I told them that I might just be one small voice, but this could be a warning of things to come, as I'm not the only one having such a negative reaction to the new Nardil. I also made them aware that there have already been some suicides, hospitalizations, and lives totally disrupted in the 5 short months since their "new Nardil" came out. They said it was a shelf-life problem they were having with the old Nardil that made them change the inactive products, but she also admitted that there have been a lot of calls and that they're aware of the fact that this batch of Nardil is not as effective as the previous one; and that they'd be looking into it. I told them it would be for their own good, or they might be facing a class-action suit. As for the Selegiline patch I mentioned before, I hope it comes out soon. It replaces all three major neurotransmitters in the brain: Serotonin, Norepinephrine, and DOPAMINE, the last one being very important for calm and a feeling of well being, and which no other medication alone does. You'd have to take a combination of two meds., like for example Effexor and Wellbutrin to replace all three. As for the GABA, if the Selegiline skin patch doesn't supplement the GABA, then a Benzodiazepine like Xanax, Ativan, or Klonopin can do that, when taken with the patch.
You can also go to the link listed below where I posted the same information, and also read about others who are having a negative reaction to the "new Nardil":

http://www.anxietyhelp.org/treatment/medication/nardil.html

 

Re: COMPAINTS REGARDING NEW NARDIL

Posted by Spotcheck on April 15, 2004, at 14:17:38

In reply to Re: COMPAINTS REGARDING NEW NARDIL, posted by SuzyQ1 on April 15, 2004, at 11:27:47

Hello Suzy,

"I have increased my dose of Nardil from 30 mg. to 45, and after 4 days, am starting to feel a little better, but still very apprehensive."

I really hope this helps you. I do not know too many people who are pleased by Pfizer's reformulated Nardil. She really did change it allot and she doesn't seem to care too much that it's not as good a medication as it once was. I mean one does not go from having 15 excipients to only having 9 keeping 3 the same, and then have the same medication. It has to be different and guess what? It really is different too. However, it does seem to work allot better than nothing, although some people who once thrived taking the old are in serious trouble taking the new because it does not seem to work for them at all.

The problem is we are going to have one heck of
hard time convincing Pfizer to change this back.
She started having production problems with the old Nardil last year or so. As a result, she let out sub-potent Nardil, and of course, people who took that began to relapse. Finally, she filed an SNDA with the FDA and made the new Nardil. Under an SNDA one has to conduct limited clinical trials, but that's about it. So, since she has done nothing illegal, it's going to be really hard to get her to make a medication she was having trouble making before. In fact, I cannot see what would force her to do this, since she apparently incapable of making the old Nardil properly anymore herself. I genuinely fear that we are stuck with this version of Nardil, period, and that is what really bothers me.

"I also take Ativan with it, to calm down the dystonic side effects of Nardil. For me, it was tight throat muscles that made me feel like I had a lump in my throat. The Ativan takes care of that. I have no doubt that the new Nardil doesn't work as well as the old one, since my blood pressure suddenly shot up about 4 months ago."

Yes, my BP is also up -- although not dangerously high yet, and a woman who was just beginning to try Link UK's Nardil was pulled off it because her blood pressure increased. It used to work precisely the oppositely, however. One's blood pressure actually dropped. Mine sure did.

"Nardil was apparently lowering my blood pressure, as a side effect, and that was a positive for me."

Yes, it was that way in me too, but it was not a positive. Mine was too low so I had real problems not getting light headed and having to quickly get my head lower. Still, I would trade that small problem for the old Nardil in a heartbeat!

"My doctor couldn't understand why my pressure for the first time was elevated, and gave me water pills. I could have had a stroke on the new Nardil, since it was no longer as effective. On 3 pills/day, my pressure has started going back down. This is besides the terrible anxiety I got again, and the depression and crying that followed. I don't know how well the 3 pills/day will hold me, but I'm praying very hard. In the meantime, I called Pfizer and raised some hell about it. They seemed to take notes. I talked to a pharmacist as well as a Nardil specialist."

I've done that too, but you will not really get anywhere talking to them. I called when I went through that complete urinary retention ordeal, and I really angry about that. They seem like very nice enough people, but so-far they have done nothing to change it back, if they even can, that is. I need to know exactly why manufacturing the old Nardil because such a problem for them.
That's what really needs to be figured out, I suspect.

"I told them that I might just be one small voice, but this could be a warning of things to come, as I'm not the only one having such a negative reaction to the new Nardil. I also made them aware that there have already been some suicides, hospitalizations, and lives totally disrupted in the 5 short months since their "new Nardil" came out. They said it was a shelf-life problem they were having with the old Nardil that made them change the inactive products, but she also admitted that there have been a lot of calls and that they're aware of the fact that this batch of Nardil is not as effective as the previous one; and that they'd be looking into it."

Here's what bothers me about their shelf-life claim. I have some old Nardil left still. I used to buy some extra so that I would always have it on hand. Well, I have a bottle that was dispensed to me by a small pharmacist dating from the year 2000 that works just fine still. So, 4 years seems like an adequate shelf life to me.

Unless Parke-Davis, the Division of Pfizer that makes Nardil, lost the ability to purchase one or more of the excipients for the old Nardil, then I honestly do not understand why they were having production problems with it at all. I need to know what was going wrong.

"I told them it would be for their own good, or they might be facing a class-action suit. As for the Selegiline patch I mentioned before, I hope it comes out soon. It replaces all three major neurotransmitters in the brain: Serotonin, Norepinephrine, and DOPAMINE, the last one being very important for calm and a feeling of well being, and which no other medication alone does."

That's only reason I do take Nardil. It used to work really well increasing DA monoamine levels.

"You'd have to take a combination of two meds., like for example Effexor and Wellbutrin to replace all three."

I might just have to give that combination a shot and recommend it to others -- if it works out well enough for me. Thanks for that piece of information Suzanne. I post under the name David F. H. at the anxiety forum will cite in your link.

"As for the GABA, if the Selegiline skin patch doesn't supplement the GABA, then a Benzodiazepine like Xanax, Ativan, or Klonopin can do that, when taken with the patch."

I already have to take some Valium with Nardil along with some Amitriptyline to treat my case of "atypical depression." I do not know if 30 mg/day of Valium is enough Diazepam to increase my GABA levels enough or at all.

"You can also go to the link listed below where I posted the same information, and also read about others who are having a negative reaction to the "new Nardil":"

Thanks Suzanne. I know that forum well. I am seriously considering hanging it up because of a very recent experience I had attempting to help a woman in Scotland. When her blood pressure increased while taking Link UK's Nardil, she got right off it and was really angry at me for recommending it. So now she's on the merry go round of trying other medications. I with here well. The kicker is that I bet the old Nardil would have really helped her out allot. I am just not going to fight with someone who refuses to take a medication that might help her. It's too much aggravation for me anymore.

 

Re: COMPAINTS REGARDING NEW NARDIL

Posted by SuzyQ1 on April 15, 2004, at 14:58:28

In reply to Re: COMPAINTS REGARDING NEW NARDIL, posted by Spotcheck on April 15, 2004, at 14:17:38

Dear Spotcheck,

The reason the blood pressure can rise with the new Nardil is because it's not as effective as the old one. As I said, up til now, it was controlling my high blood pressure, as a positive side effect. For some people who had normal pressure, it made it too low. I don't know what happened with that lady you mentioned. She might have had a reaction while her body was adjusting to the Nardil and it made her pressure shoot up. In my case, I had what's know as REBOUND HYPERTEN SION, which could be very dangerous. You see, the new Nardil made it as if I were a person taking a medication for high blood pressure, and suddently stopped it. My arteries could have easily contracted to the point of giving me a sudden heart attack or a stroke. That's even more serious than rebound anxiety and depression, because I might not have had the time to increase the Nardil or switch medications. This is a criminal act by Pfizer, if it can be proven. I've been feeling like hell for the past 4 months or so, with migraine headaches, and every artery in my head and under my scalp swollen to the point that I had to hold my head most of the time. This was the result of the "new Nardil." I have no doubt about it. Even my medical doctor can vouch for my pressure being stable for years, til 4 months ago when it suddenly shot up. I just talked to my therapist on the phone, and he suggested I talk to Pam Zechman here in Chicago. I believe she's on ABC news. I can refer her to the two websites that discuss the nightmares of the new Nardil. An expose from her on a network TV channel could reach a lot of people, who til now might not know about the new Nardil affecting them negatively. They might think it's something strictly different with them. I'll check into it.
Suzy

 

Re: COMPAINTS REGARDING NEW NARDIL » SuzyQ1

Posted by Spotcheck on April 15, 2004, at 15:59:51

In reply to Re: COMPAINTS REGARDING NEW NARDIL, posted by SuzyQ1 on April 15, 2004, at 14:58:28

Hello Suzanne,

There's no question in my mind that these two versions of Nardil are different due precisely to the change in excipients that Pfizer made. So one should suspect that they would be metabolized differently as well and they are.

The old Nardil lowers blood pressure. The new Nardil increases blood pressure.

"As I said, up til now, it was controlling my high blood pressure, as a positive side effect."

Yes, that certainly would be. Beats the heck out of taking high BP medications too, I suspect.

"For some people who had normal pressure, it made it too low."

That's what happened to me, but I could easily live with it. I just had to adopt some different coping strategies, and soon I felt just fine again.

"I don't know what happened with that lady you mentioned. She might have had a reaction while her body was adjusting to the Nardil and it made her pressure shoot up."

Unfortunately, I honestly do not know what happened to her either, but apparently she became dizzy, her blood pressure increased and when she went to have it taken, they decided she should discontinue using it. Me? I think she stopped too soon, but she's a very difficult person with which to deal. She already feared this medication and the potential interactions with Tyramine so much that she did not know what she could eat and what she should avoid. It was easy enough for me to explain this to her, but was always extremely reluctant to press forward and continue taking it.
You can lead a horse to water, but........

"In my case, I had what's know as REBOUND HYPERTENSION, which could be very dangerous. You see, the new Nardil made it as if I were a person taking a medication for high blood pressure, and suddently stopped it. My arteries could have easily contracted to the point of giving me a sudden heart attack or a stroke. That's even more serious than rebound anxiety and depression, because I might not have had the time to increase the Nardil or switch medications. This is a criminal act by Pfizer, if it can be proven."

Now, that would not have been a pleasant experience at all. Nobody needs to stroke out or have a heart attack. I hope you can prove it, since I would very much like to get to Pfizer myself.

"I've been feeling like hell for the past 4 months or so, with migraine headaches, and every artery in my head and under my scalp swollen to the point that I had to hold my head most of the time. This was the result of the "new Nardil."

When I took 60 mg of it I get a severe headache myself. I had never experienced that one before, but it was uncomfortable, but fortunately for me that dosage is too high. I need to be in the 45 mg range and pretty much always have even with the old Nardil. I could simply take less of it because it more effective in me.

"I have no doubt about it. Even my medical doctor can vouch for my pressure being stable for years, til 4 months ago when it suddenly shot up."

I concur. It's no coincidence that's for sure. It's the new Nardil not working the same way in your body precisely because so many excipients were changed with it was reformulated by Pfizer.

"I just talked to my therapist on the phone, and he suggested I talk to Pam Zechman here in Chicago. I believe she's on ABC news. I can refer her to the two websites that discuss the nightmares of the new Nardil. An expose from her on a network TV channel could reach a lot of people, who til now might not know about the new Nardil affecting them negatively."

Go for it Susanne! Although I seriously doubt that very many people have not noticed some changes within themselves. I sure did and so have allot of other people. I believe it's an inferior medication in fact, but so far we have gotten nowhere dealing with Pfizer of he FDA.

If I knew the formulation of the old Nardil, and could afford to buy the mixer, dryer, granulator, tablet press, and equipment required to spay that bright orange M and M shiny color coating on each pill, then I would make it myself. Unfortunately, that information is quite simply not available. One would have to get it from Pfizer (Probably Parke-Davis or the Warner Lambert Divisions) which they are not going to give away and which is not written anywhere else to the best of my knowledge. It is not on any patent either. That much I have discovered since I tracked the patent history of Nardil down. There are only two patents on it: one for the original Lakeside Pharmaceuticals which I found on the internet and then simply access the Patent number so that I cloud read the document and another for Warner Lambert, which I found in the 2003 PDR in my public library of all places. But I cannot find a thing for the old Nardil dated any later than 1967, and that document does not include the formulation information of the old Nardil. It ha some example like simpler tablets, elixirs and suppositories, but that is all.

"They might think it's something strictly different with them. I'll check into it."

Wow, I just do not believe most people would not notice the change. I think that Nardil is just a pretty old drug that Pfizer does not make a deal of money and that once she ran into those production problems with the old Nardil now, not the new Nardil, then she decided she had one of two choices:

1. Stop making Nardil completely
2. Reformulate it as best she could

It is now made in France, although the facility cold be Pfizer's since she is an International Corporation.

David F. H.

 

Re: Nardil from Australia = 1950's version.KV » King Vultan

Posted by Timidly on April 15, 2004, at 20:53:58

In reply to Re: Nardil from Australia = 1950's version.KV » Spotcheck, posted by King Vultan on April 11, 2004, at 17:04:57

Parnate gives me tachycardia so it is not an option for me. Nardil is the only AD that has every helped me. The Nardil change has had an enormous impact on me. I increased to 120 mg/day since first having problems with the new Nardil. Unfortunately that increase in dose and taking one pill at a time spread out over the day has not made any difference, I continue to regress deeper into depression. Timidly

> I quite agree that either Parnate or Effexor would be the drugs to go to for those for whom the Nardil is unfortunately no longer effective. I'm curious as to whether you have an estimation as to what percent of Nardil users have been negatively affected by the formulation change. Are there some people who have not noticed a difference?
>
> Thanks,
> Todd

 

Re: COMPAINTS REGARDING NEW NARDIL » Spotcheck

Posted by King Vultan on April 15, 2004, at 21:03:23

In reply to Re: COMPAINTS REGARDING NEW NARDIL » SuzyQ1, posted by Spotcheck on April 15, 2004, at 15:59:51

David, don't get too discouraged about the dysphoric lady in Scotland, as I think you've provided an absolutely invaluable service with all the information you've provided on this Nardil issue. I think there's no question you're correct as to Pfizer/Parke-Davis losing the ability to make the old formulation properly and being forced to reformulate it into the current version, which is unfortunately less effective for so many patients.

I'm a little surprised Suzy's doctor was not aware of the relationship between MAOIs and blood pressure, as hypotension has been recognized as a common side effect of MAOIs for decades, as well as reduced heart rate. I have essential hypertension myself (barely, at 140/90), and I'm seeing enough of a reduction in BP on the 75 mg/day of the Nardil I'm on so that I've cut my lisinopril BP med from 10 to 5 mg to observe whether I can get away with dropping it entirely. As I mentioned in another post elsewhere on the board, my heart rate has also declined significantly, from about 75 to 60 beats/minute.

I have not yet achieved the full antidepressant response I'm looking for, but the results so far give me hope that I may be one of the fortunate ones for whom the med still proves to be a blessing. Thanks again for all your efforts in clarifying what is going on.

Todd

 

Re: COMPAINTS REGARDING NEW NARDIL

Posted by Spotcheck on April 16, 2004, at 0:23:45

In reply to Re: COMPAINTS REGARDING NEW NARDIL » Spotcheck, posted by King Vultan on April 15, 2004, at 21:03:23

Todd, I am not so much discouraged as I am frustrated by what happened. I need to be able to see these people and run some simple tests on them, blood pressure being one of them. Had I known her BP was increasing, I would have yanked her off Nardil too. That is one of the problems of dealing with people via e-mail or board posting. One cannot see how they are doing much less run any tests to verify that things are all right and tell them to hand in there, when the are.

What I would truly like to know is why Parke-Davis lost her ability to make a reliable old Nardil. I can only think that the availability of certain critical excipients changed. If so, I wish she would just admit it or at least explain it terms other than shelf-life and dissolution. If not, then what's her problem?

"I'm a little surprised Suzy's doctor was not aware of the relationship between MAOIs and blood pressure, as hypotension has been recognized as a common side effect of MAOIs for decades, as well as reduced heart rate."

Agreed, but as you can see in Suzy's case her blood pressure actually increased on the new Nardil, instead of decreasing as it had on the old. That tells me that something fundamentally different is happening to her, which is not good at all. Since the only change that was made were those excipients, it has to be them.

"I have essential hypertension myself (barely, at 140/90), and I'm seeing enough of a reduction in BP on the 75 mg/day of the Nardil I'm on so that I've cut my lisinopril BP med from 10 to 5 mg to observe whether I can get away with dropping it entirely. As I mentioned in another post elsewhere on the board, my heart rate has also declined significantly, from about 75 to 60 beats/minute."

That sounds really good, Todd.

Without taking any version of Nardil my BP is normal at 120/80. When I took the old Nardil, it dropped considerably so that it was close to 100/80. I had real trouble with hypotension. When I would begin to feel faint, I would have to get my head down lower than my heart then contract all of my muscles, and wait until my BP was high enough for me to feel all right again. But it was a real inconvenience, I will admit that.

Now, get this. When I began taking the new Nardil, my blood pressure increased to 132/90. Because I only have to take 45 mg of it, I can get along just fine on it, but I would have bet allot of money that my BP would have dropped again too. So again, I think altering those excipients has truly changed the way I respond to it and this change is not nearly as welcomed.

"I have not yet achieved the full antidepressant response I'm looking for, but the results so far give me hope that I may be one of the fortunate ones for whom the med still proves to be a blessing."

Todd, I do not know what else you respond to if anything, but I do respond rather well to amitriptyline HCL which I use in combination with Nardil to achieve a complete state of the elimination of both anxiety and depression. If Nardil alone does not quite do it for you, you should consider adding something that works for you with it. It was the only way for me to go!

David

 

Change of Pace? To All!

Posted by Spotcheck on April 19, 2004, at 19:02:23

In reply to Re: COMPAINTS REGARDING NEW NARDIL, posted by Spotcheck on April 16, 2004, at 0:23:45

All right, I have finally finished my Phenelzine Elixir. It's tastes awful, but it's quite effective. I believe that I am finally done with Pfizer which is what really feels good. I have been dealing with her since 1979. That now seems to have come to an end.

I will be working on other Elixirs to replace these tablets so that I no longer need any of the Pharmaceutical companies. Nardil was the hardest medication to replace. The others should be allot easier.

You had better there are more ways than one to skin a cat! I just did it, thank God!

 

Re: Change of Pace? To All!

Posted by luther on April 21, 2004, at 2:38:05

In reply to Change of Pace? To All!, posted by Spotcheck on April 19, 2004, at 19:02:23

> All right, I have finally finished my Phenelzine Elixir. It's tastes awful, but it's quite effective. I believe that I am finally done with Pfizer which is what really feels good. I have been dealing with her since 1979. That now seems to have come to an end.
>
> I will be working on other Elixirs to replace these tablets so that I no longer need any of the Pharmaceutical companies. Nardil was the hardest medication to replace. The others should be allot easier.
>
> You had better there are more ways than one to skin a cat! I just did it, thank God!

Hi Dave,
I'm sorry to be so rude, but you spend far too much time on this site. I'm really tired of you calling Pfizer a she. It is really a company. As small amount of Nardil you take, why are you advising anyone with what they should do? Amitryptiline is one of the very worst tricyclics one can take, no wonder you're unable to urinate. I try to be positive, but all I see are your postings one day after another, please do us all a favor and find a new hobby.

 

Re: Change of Pace? To All! » luther

Posted by Spotcheck on April 21, 2004, at 3:16:24

In reply to Re: Change of Pace? To All!, posted by luther on April 21, 2004, at 2:38:05

Hello there Brian,

How in this world are you? I'll cut to the chase so that you can apprise me of how you are doing,
yourself, which I hope that you actually do.

"I'm sorry to be so rude, but you spend far too much time on this site. I'm really tired of you calling Pfizer a she. It is really a company."

I wish you would not say you are sorry to be rude, and then go right ahead and be rude, Brian, because that is rude behavior itself.

"As small amount of Nardil you take, why are you advising anyone with what they should do?"

Because Nardil became allot more important in many more people's lives than just mine. I also believe that I can be of some help to other people. Is that believe misfounded or misguided do you suppose?

"Amitryptiline is one of the very worst tricyclics one can take, no wonder you're unable to urinate."

You mean, in your opinion Amitriptyline is one of the worst tricyclics one can take, correct? It does have some powerful anticholinergic side-effects, but it's highly efficacious in me. You know what else has powerful anticholinergic properties too, Brian? Nardil! That's right! I switched to Trazadone once though, Brian, but Trazadone did not help me as much as AMI does. Since I do not take psychotropic medications that do not help me, that seemed like the wisest course of action here, and would you believe my Psychiatrist, agreed with me?

"I try to be positive, but all I see are your postings one day after another, please do us all a favor and find a new hobby."

I appreciate the vote of confidence, Brian. I will come and go as I please here, and as as Dr. Bob's rules dictate, since this is his board not mine, and not yours. I truly do wish I could have helped you out though, Brian, because I can. However, you failed to reply to my e-mail. So, I had to let matters drop. What would you have done differently -- had you been me and I you?

Warmest Regards,

Spotcheck David

 

Re: please be civil » luther

Posted by Dr. Bob on April 21, 2004, at 23:44:00

In reply to Re: Change of Pace? To All!, posted by luther on April 21, 2004, at 2:38:05

> please do us all a favor and find a new hobby.

Please don't post anything that could lead others to feel accused or put down.

If you have any questions or comments about this or about posting policies in general, or are interested in alternative ways of expressing yourself, please see the FAQ:

http://www.dr-bob.org/babble/faq.html#civil

or redirect a follow-up to Psycho-Babble Administration.

Posting something about your own issues and their possible role in your reaction might be an interesting exercise -- and might help others respond to you supportively.

Thanks,

Bob

 

Re: please be civil

Posted by luther on April 27, 2004, at 17:37:31

In reply to Re: please be civil » luther, posted by Dr. Bob on April 21, 2004, at 23:44:00

I'm sorry Dr. Bob and Dave, that is not the real me. This new Nardil really has me messed up and I know I'm not the only one. Many of us are struggling due to corporate greed. I'm very sorry Dave for only thinking about how I feel. I can relate to your predicament as well.
Sincerely,
Brian

> > please do us all a favor and find a new hobby.
>
> Please don't post anything that could lead others to feel accused or put down.
>
> If you have any questions or comments about this or about posting policies in general, or are interested in alternative ways of expressing yourself, please see the FAQ:
>
> http://www.dr-bob.org/babble/faq.html#civil
>
> or redirect a follow-up to Psycho-Babble Administration.
>
> Posting something about your own issues and their possible role in your reaction might be an interesting exercise -- and might help others respond to you supportively.
>
> Thanks,
>
> Bob


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