Thanks for the information and advice on MVP. I never heard of this condition getting worse to the point of surgery.

I had a nuclear stress test 2 years ago, and it was normal.
I will definitely keep a watch on this.
Thanks again,
Helen K.   (Thu May 8 20:27 2008)

The surgery left me with NO more Heart murmur!!!It is gone!   (Thu May 8 14:03 2008)

My Mitral valve prolapse was also inconsequential most of my life...or so I was told...so I was really suprised when My heart became enlarged and I was told that the leaking had worsened to the extent that surgery was necessary. I never would have known except I had bronchitis that seemed to hang on for two months. A subsequent x-ray showed the enlarged heart--then an echocardoagram showed the prolapse had become worse. I mention it to you so you keep an eye on it ...I didn't realize that it coud get worse and have met two people who had the same thing happen. So important to keep the heart monitored for that...if you notice shortness of breath too.......Anyway , it can deteriorate over time BUT also excessive hi blood pressure can also worsen it. That's where I think either parnate or the new Nardil was the culprit in my case....Take care!   (Thu May 8 14:01 2008)

Hi Dan:
No, I haven't heard back from Validus.

I am taking 90mg Nardil (twice as much as the old Nardil).
I also take 275mg of Lamictal. (This took over 6 weeks to kick in).
I take 7.5 mg of Dexedrine for energy.
I take B complex vitamins, multi vitamin,
and Omega 3.
I am not hurting or in pain with this formula, but I still cannot get my full energy; can't work or do many things I did before.

It seems the potency and efficacy of this Nardil changes by lot to lot, or even pill to pill. There is never any consistency.

I plan on trying Parnate, but weaning off Nardil is the most God-awful experience ever imagined! I don't know how others do it.
I've taken Nardil for 20 years, so maybe that's the reason.
Thanks for writing.
Helen K.   (Thu May 8 12:35 2008)

May 8 2008 For whatever it's worth, I was on old Nardil for many years but it quit working early 2004. I started back on the Pfizer Nardil at 45 Mg/da on Jan 1 this year. So far it is doing a better job than the 15 or so others plus ECT. Maybe their quality control is better. This is for people that have been reluctant to try again. I have my fingers crossed but so far so good. I have some postings in Nov and Dec of 2007 if your interested. AHR   (Thu May 8 10:15 2008)

Hi Helen, just wondering if you have heard anything more from anyone at Validus? I was also wondering if you currently take Nardil, and if so, how much? Thanks for your posts and thanks for your input, I appreciate it. Been having a rough time here lately and am having to figure out what to try and take or add in order to get back to functional. Anything you can think of would be helpful. I have talked to Dr. Harris at Validus and they have passed it up the chain to the business people and management regarding what they wish to do regarding an attempt at acquiring Nardil from Pfizer. I need to find out who to track it with now without being "pushy" -- sorry for rambling. Thanks. Dan
   (Wed May 7 18:33 2008)

So glad to hear you got thru the surgery OK, and are doing well.

I also have Mitral Valve Prolapse. I've been told it's minor, and not to worry.

I recently read that MVP causes instability of the autonomic nervous system. This can cause problems with blood pressure, heart rate, sweating, body temps., anxiety, gastrointestinal activity etc.

It can also cause exaggerated stress responses, causing excess stress hormones called catecholamines. This leaves you with a washed-out feeling.

I read with great interest that MVP depletes magnesium. Check out some of the websites on this mineral, and see just how important it is.

Helen K.   (Wed May 7 17:46 2008)

I should add when I first had panic,anxiety,depression problems many, many years ago(30) I suspected that the heart murmur might be a factor.I even visited various heart drs at the time before going on medication. There is a school of thought that believes it causes an effect. Now, I no longer have a heart murmur since my surgery repaired my mitral valve which may be another reason why my depression did not worsen after surgery. That could be a contributing factor...   (Tue May 6 20:51 2008)

Hi helen,
I was able to have my surgery without stopping the Nardil....Years ago I had surgery with original Nardil and also was able to continue without stopping the drug. They did say I experienced some blood pressure problems during surgery which they were able to handle . All in all the surgery went well...and although I have read that many who have heart surgery have depression afterwards I did not which I feared would be a problem. I think it helped that I never stopped the medication.   (Tue May 6 20:27 2008)

"The truth is, I had my comp. pharmacist create liquid Nardil IAW Dave's formula."

No, you did not, because the concentration of the LN you got was just crazy, and incredibly low IIRC, and I do too.

Otherwise, I agree with your statement entirely. The truth is none of us knows why LN works in some people and not in others. Your hypothesis is as good as any. Howevever, if I make it myself, I can indeed replace "old" Nardil exactly for me and for Horst.

I hereby swear that this is the God's honest truth.

DFH -- Spotcheck.

My guess is that if you stopped taking that Benzedrine suddenly, you would feel the effects almost exactly as you describe them.
However, I do not know if you stopped taking it or not. However, if you did, then that could be one explanation of this problem as well as that low Phenelzine Sulfate concentration.

Note: I knew I should not have said a word here, but I just hate being censored and so I did, since I believe that Dan is asking for very real answers to his problem.

I have nothing against you however, Helen. I would like your mental health to improve of course, but that's point of this board.   (Tue May 6 16:18 2008)

Dave has misinformed the members here.

The truth is, I had my comp. pharmacist create liquid Nardil IAW Dave's formula.
It did not work one iota. I sunk very fast into the depths of depression. It was like taking zero Nardil. I could go no further than 3 days in this state of suffering.

Dave then sent me a shocking e-mail telling me in no uncertain terms that if I did not try liquid Nardil again at a higher strength, then I did NOT want to get well (among other insults).

I believe the liquid Nardil did not work in me because it lacked excipients which transport the Phenelzine past the blood-brain barrier. It drains out of my stomach like water.

I thought Dave and I since mended fences, but now I'm not so sure.
Helen K




   (Tue May 6 13:30 2008)

I am curious: Did you have to go off Nardil before your surgery?
Thanks,
Helen K.
   (Tue May 6 13:05 2008)

I still have hope that maybe Validus will pick up this drug, Pfizer will let go of it... and we can feel really good again!

Thank you for relating your story. Stay well.

Dan

Note:
ValidusPharma.com
Dr. Herbert Harris
973-265-2777 ext 111
866-9VALIDUS   (Tue May 6 0:51 2008)

Hi Dan, The first year of the change was terrible for me. I had numerous test thinking my brain was damaged by alzheimers or something else.Also had battled the weight gain for years only to have the new formula add even more weight plus the swelling in my legs that has been with me since 2003. I later tried Parnate to no avail but found the stretch being away from the new Nardil made the reintroduction a little better. I also augment my drugs with a liquid vitamin complex "Liquimax" which has Omega 3 in it.They sell it at Costco. I also try to exercise which I think helps. It does not work as well as the original formula but it has improved from when it was first changed. I think they also improved the coating a little which may have helped. I will add that 3 months ago I had to have open heart surgery for a repair of my mitral valve.Although that can be needed due to heart murmur worsening I think mine got worse due to Parnates raising of my blood pressure and Nardil now also raises it when it used to lower it! I wouldn't be suprised to find out the drug caused the need for that surgery. I had a great heart Dr so am recovering well and back to work. I do admit it does NOT work as well as the original formula unfortunately. It is still better than anything else out there. I got my brother to take it after he also tried numerous other meds to no avail. He says it works beter than any of the others he has tried. I only wish he had been able to try it in the original formula. I've told him it would be much better if it was the original.   (Mon May 5 19:25 2008)

"Dave, what meds have you found to be helpful to people who are not getting any relief from this "New" Nardil? I would really appreciate your input. The "New" stuff just doesn't work for me..."

I understand that, Dan. I cannot tell you now sorry I am that this generic crap does not cut it, but it's been so radically changed from the original, that it should come as no surprise to anyone who understands how this medication used to work.

1. Have you tried Parnate?
2. Have you added Lamictal?
3. Have you considered trying to add a bit of dexedrine?
4. Do you respond positively to any other medications?
5. If you find that Parnate helps you some you could augment that with a high dosage of Neurontion -- which would affect your GABA concentrations.

Note: I created an elixir that saved one man's life. His name is Horst Gatz and when I first started working with him, he was bedridden. The problem here is that this is an experimental medication that has worked in two males only:

1. Me.
2. Horst.

It's failed in two females, and so I withdrew it since I am not at all interested in being sued to death, if you understand my drift. Oh, I understand, but it's just not a satisfactory position in which I would be placing my family.

With Horst everything went as planned. With me it was a simple substitution. Not so with the two females who tried it. One I never worked with. The other, Helen K., was so pissed off at me after she tried it for 3 days, that I thought I would be sued by her.
Nothing personal, but I do not consider 3 days to be a therapeutic test. Helen will likely kick in me in the rear end for saying this, but it's true.

This stuff is expensive though, because it's made from nothing but the purest Phenelzine Sulfate one can find. And that's it's drawback, too. Nobody knows how it works, including me! It just did in me and it saved Hort's life. That's all the data I have to go on. If you wish to discuss this further send me your e-mail address. I will not post mine here anymore. That's because I let it expire intentionally.

"Please understand, I have tried so hard to get someone to look at making Nardil because IT WORKED for me. If the only version left is Pfizer's, then I have to find a way to boost its effects or find another med or
combination of meds."

I know it, but there are darned few options here, Dan. That's the God's honest truth. Don't you think that I would cure everyone if I could? Of course I would, but it just does not work this way.

Note: This is what pisses me off so badly. Pfizer decided to simply toy with thousands of people's lives, all to cut her bottom line expenditures. I cannot in good consious promise anyone anything, however. One simply must try other medications that could work with this Nardil.

Note: I know one fellow who's a PA who used to post here and was part of NPAC. He and I tore Pfizer's work up for the FDA. There is no single combination of medications that works for him now. He has to rotate around until his Nervous system reaches tolerance. Once that occurs, he then starts feeling terribly and so he must then changeis medication regimen again. Not that sucks, because he's never comfortable any more. None of you are in this alone. It just feels that way because you no longer feel good in life.   (Sun May 4 22:18 2008)

Mary, how much of the "New" Nardil do you have to take? Does it help? Has anything else that you've tried since the reformulation worked? Thanks. Dan   (Sun May 4 19:59 2008)

Look, Pfizer may be stupid enough to abandon Nardil...I don't doubt it. BUT , It is a remarkable medicine. If you have followed the revelations on the SSRI's then you know that the supposed studies that were done on those were fabricated and worthless. As this information becomes more available there will be those manufacturers interested in making a drug that WORKS! Unfortunately many of the Dr's that know about MAO's have retired . I wish there was even one responsible psychiatrist who would write about the successes of this drug. I know it saved my life over 25 years ago and even in it's inferior form is better than any other drug on the market for me and many,many others. As the bad effects of SSRI's become more well known --suicides and school and workplace violence are one effect...you will see more searches for better drugs.Someone will realize the older drug is better..Nardil.    (Sun May 4 19:05 2008)

Nardil does cause urinary retention, but I have had no infections ..BUT I drink cranberry/grape drink every morning. Cranberry really does help!!!   (Sun May 4 18:55 2008)

I have taken Nardil for many years, but for the last several years I have terrible side effects of urinary retention causing very bad urinary tract infections needing Antibiotics, I don't know if this is a cause of the new Nardil or didn't have as bad as previously, I don't know what to do, I have tried eveything else on the market for Panic disorder and this drug is the only one that has actually worked, does anyone else have this problem???, please HELP!   (Sun May 4 18:45 2008)

Dave, what meds have you found to be helpful to people who are not getting any relief from this "New" Nardil? I would really appreciate your input. The "New" stuff just doesn't work for me...

You have been here since the beginning of this fight for our health. I have read most of your posts. Any suggestions you may have regarding what works when Nardil doesn't, would be welcome.

Please understand, I have tried so hard to get someone to look at making Nardil because IT WORKED for me. If the only version left is Pfizer's, then I have to find a way to boost its effects or find another med or combination of meds.

We are ALL here for the same reason. That medication helped with both anxiety and depression and did it very effectively. We want to feel good again. We want our lives back.   (Sun May 4 18:21 2008)

I hope you're correct, Dan. Please excuse me
if I do "not" hold my breath for this to develop, however.

Note: Nothing personal intended at all.   (Sun May 4 11:10 2008)

Validus Pharma has expressed an interest in seeing if Nardil could be added to their product line. I believe that I will let them look at the numbers and make their own decision. Don't give up on this yet...

Validus has a different view of things than Pfizer!

My contact is Dr. Harris at 973-265-2777 ext 111
866-9VALIDUS is the main number.
The website is ValidusPharma.com    (Sun May 4 1:05 2008)

is correct. All of you need to know this fact: the truth is that there is not very much money to be gotten by making Nardil at all. At most we had say about 200 complaints. Well, that's just not enough to get anyone to seriously look at making this medication in the older formulation. Capiche?

I wish things were otherwise, but they are not! Hence, Pfizer's unwillingness to wiggle on this medication, and her price increases for a worse medication.   (Sat May 3 2:22 2008)

Dave..you should tell these people what seems to be the bottom line. you have cresability. yes i have been to pfiser corporate hdq three times. they will not yield and are tough as hell. dave with ln and all in the name of our blessed lord jesus whatelse could be forreal. there is no money in nardil. pfiser made it clear to me they were still making it as a humanitarium gestture. that was about 2 years ago. with the stock down another 40% they could drop nardil in a heartbeat   (Fri May 2 21:08 2008)

One of the biggest problems with complaints is many people never even realized Nardil was changed. I know it was over a year before I stumbled across Vickis site and finally knew why I was suffering...despite having one of my Drs contact Pfizer who then denied that any changes had been made. What bothers me is there are so many people out there who would have greatly benefitted from the original Nardil instead of the SSRI's which I don't think work that well for anyone. I have family memebers who take them and their recovery is incomplete compared to my own even with the newer Nardil!! That is something JAZZ should consider....that recent information shows that the studies on those SSRI drugs were not very good and hidden by the drug companies.Someone who marketed Nardil correctly would do very well in light of that revelation.   (Fri May 2 18:56 2008)

1. Numbers? No, I'm terribly sorry about that, but the only number I've seen bandied about here is 80,000 to 85,000. However, I believe that's the total of Nardil users.

2. I've seen this written about at Dr. Bob's.
Otherwise, nowhere else.

Note: I know this has not be especially information and I almost did not post it because of that, but I dicided to anyway in cause you could use it.

Where'e Bob in all of this mess?   (Fri May 2 9:42 2008)

I have written something that I'll be sending to Validus...Do we know how many people are on this (Anxiety) site, a sort of general number about the number of complaints? And apart from this site, I have another two. I'd appreciate your input if you know of other sites with Nardil complaints. Thanks.   (Thu May 1 18:54 2008)

Ah, it was Judy McC. Forgetful... I finally remembered her name. I've just not heard from her nor seen her post in months now.
   (Thu May 1 14:28 2008)

Hi Mary , I'm glade to see you're still hanging in there too. Sorry to hear about your brother, I hope he's ok now.Yes, the FDA
is as they say the Best endorsement money can buy.It's sad what this country is comming to.How long can it last when corruption starts at the top.I too remember
awhile back of someone having leg swelling .
I would say keep them elevated when you can,
but I'm not a Dr. - Keep hanging in there!!   (Thu May 1 13:44 2008)

There was one female, who for a very brief time was an NPAC member Mary, and because she had to take high dosage of "new" Nardil (120mg / day), she too suffered swelling of her legs. I wish I could give you here name, but I cannot remember it to save myself.

Note: I know that she lived close to Washington DC.

No comment on the FDA: anyone who has dealt with her knows they suck.   (Thu May 1 11:49 2008)

I don't know if any of you saw the hearings yesterday on Heparin. My brother nearly died last month from heparin...but 81 people DID DIE! And now they are saying they think the additive in Heparin was put there deliberately. The globalization and outsourcing of manufacturing is screwing us all in many,many ways. From loss of jobs, quality and standard of living. BUY AMERICAN when you can and support American companies. There is a book out now called "BUY American". Support your own countrymen before we lose our country!
PS-anyone else have swelling from the new NARDIL? I have swelling below my knees from it and my orthopedic surgeon says he never saw anything like it! Thanks PFIZER!!! Keep counting your money you low life scum sucking greedy PIGGISH Snakes...(sorry snakes-didn't mean to lump you in with a lower form ). AAAHHHH that feels better already!! Hey Joe how the heck are ya? Glad to see you are Still hanging in !!!   (Wed Apr 30 17:59 2008)

Come on people there is only so much that the
FDA can do , I'm sure all five people that work for that agency are maxed out.Someone has to collect those million dollar checks
that come in the mail each day. then someone has to run to the bank, another keeps the books up to date,one answers the phones and one plans the lunch menu and keeps the coffee
pot full.So it's great that the pharmaceutical companies do all the testing for us.Get your money for nothing and test for free . Thats the way ya do it at the FDA, those guys ain't dumb...   (Wed Apr 30 3:57 2008)

That was my experience working with NPAC -- after two of us just tore the methodology of the way in which Pharmaceutical Company's get to test their own medications.

The answer we got to 40 questions we posted was essentially this:

"Well, we do things that way, because we've always done things this way."

Yet there is flaw in allowing any company to run the clinical trials of these medications. Someone who is non-biased should be doing that, but of course this is not the case.   (Mon Apr 28 19:59 2008)

That was my experience working with NPAC -- after two of us just tore the methodology of the way in which Pharmaceutical Company's get to test their own medications.

The answer we got to 40 questions we posted was essentially this:

"Well, we do things that way, because we've always done things this way."

Yet there is flaw in allowing any company to run the clinical trials of these medications. Someone who is non-biased should be doing that, but of course this is not the case.   (Mon Apr 28 19:59 2008)

If you saw any on the hearings on the FDA you should know that the FDA is about as worthless as a three dollar bill.....They don't even have any oversight over the imports we are ingesting in medicine,food , toys etc. No, It will take a new admministartion and purging of most of the represenatives to get anything done worthwhile. Look at the heparin situation, Vioxx etc. This organization ain't worth a damn   (Mon Apr 28 19:37 2008)

CAN ANY ONE OF YOU REACH: JOSEPH LAZARICH>:
CHIEF MARKETING OFFICER AND EXPLAIN OUR PROBLRM WITH THE NEW NARDIL ????
at: jlarich@validuspharma.com
Thank you   (Sat Apr 26 15:32 2008)

I am not dead yet. I am still ALIVE
All of you take care
Your friend Luigi (Canada)   (Fri Apr 25 18:15 2008)

Hi Loula:
Many numbers of us have filed the FDA MEDWATCH form -- repeatedly. They do not answer or even acknowledge our pleas.

I wrote a 3-page letter to Pfizer Complaint Dept. last month, and have heard nothing. I enclosed 3 tablets of inert Nardil I received. The tablets were empty, and they promised to investigate. Have not yet heard a word.

Maybe I'll forward the letter to this Fezcko, but don't expect much.

Still, I say: GO DAN. Don't give up on this Validus thing. Anything is worth a try...
HelenK   (Fri Apr 25 17:48 2008)

I have been asking my brother, who works at a pharmaceutical company about measures to be taken, further steps to help in this endeavour. First he suggestes strongly filling out the FDA MEDWATCH FORM (I found it online easily-1 page to be filled out) Secondly, he says to write to the Chief Medical officer at Pfizer (Dr. Joe Feczko, just looked it up)who, probably won't do anything, but the company will then have on record the complaint forwarded to the right person. This is apparently useful should litigation go fwd at any time in the future.   (Fri Apr 25 13:32 2008)

DAVE email if you can. same email. yours has changed   (Fri Apr 25 7:01 2008)

Agreed. Thanks. As always, I appreciate your input. Dan   (Thu Apr 24 23:11 2008)

You're absolutely right!

Thank you for the input. Can't imagine big greedy Pfizer NOT having a way to reconstruct our old friend Nardil when someone offers them the bucks to do it.

I think we should know here shortly how much they want -- or even if(?)they are willing to sell rights to Validus to produce "Real" Nardil...

Thanks!

Dan
   (Thu Apr 24 23:01 2008)

I don't think anyone would destroy the original. They would probably keep it somewhere. And if they did someone can reinvent it...after all that was half a century ago...surely we have evolved . (Except if China is working on it..then we are screwed! It is worth a shot and that's all anyone can hope for ...right?   (Thu Apr 24 19:57 2008)

Dan, I was hoping you would understand what I was trying to do there:

1. Not make NY Marine feel as though he was out of bounds with his statement.

2. Not get false hopes up either.

Let's find out if Pfizer has this information in her Computer databases, all right? That would be where I would store such information. You?

Warmest Regards,

Spotcheck Dave

PS

{Sheesh!}   (Thu Apr 24 13:59 2008)

Who said anything about fools??? HUH?

Dave, you simply have a wide variety of people all trying to get better who had the props knocked out from under them when Nardil was "reformulated." We would all like to see the "Old" stuff back just as it was... and just as soon as possible. No fools. No false hopes. (Really Dave.)

Don't put words in my mouth.

I simply asked the man if he thought Pfizer still has the original formula.

I also asked him what he was currently taking.

Dan
   (Wed Apr 23 22:06 2008)

We cannot know now what Pfizer has and what she does not have, but why would she not keep this information in her computers, and not rely upon paper at all?

PS New York Marine and I go way back. He's no fool so it's a mistake to think that he might be.   (Wed Apr 23 19:51 2008)

I know it seems unlikely after all this time. I wonder if Pfizer wouldn't still have the original formula? What are you taking that helps you... are you on this new stuff, or did you have to switch to something else entirely?   (Wed Apr 23 12:12 2008)

i am sorry you guys. it is evident the original recipe for nardil was shtedded 5 years ago. it is impossible to imagine a company spending so much $$ at a time with the drug companies are hurting so bad. if this plays out what will you pay 75 dollars per 1 15 mg nardil pill   (Wed Apr 23 0:29 2008)

Alarm Bells-
Some critics say the FDA, in effect, was saying, "it's all in their heads." But they were more alarmed to read in the report that the FDA relied on tests comparing a lower dose of Wellbutrin and Budeprion -- 150 mg -- when it first approved the 300 mg version in 2006, and didn't have specific bioequivalence data on the 300 mg dose that had generated the complaints.

"Everybody involved in this whole chain -- pharmacists, physicians, insurance companies, drug-store buyers -- assumes the FDA approves every single generic formulation to prove that it isn't harmful," says Mr. Graedon. "We learned last week that that's not the case."

The FDA explained that it didn't want to expose test subjects to the risk of seizures with the 300 mg dose. Bioequivalence tests are conducted on healthy people, not those who need the medication, and each gets just a single dose, so there is no chance to work up to 300 mg slowly, as actual patients are advised to do. Sandy Walsh, an FDA spokeswoman, says this is common procedure for testing antidepressants and antipsychotics.

"If we see scientific evidence that a product is not performing as expected, we will take action," Ms. Walsh says. "The FDA cannot offer examples where generics have not performed as expected because there have been none for the agency to report."

Bioequivalent

Deborah Jaskot, vice president for regulatory affairs at Teva Pharmaceuticals USA, which distributes Budeprion, says the ConsumerLab dissolution test was an invalid comparison, and that on all the accepted tests, Budeprion performed within the range of bioequivalence with Wellbutrin. Teva itself has received 101 reports of problems with Budeprion -- out of 4.5 million prescriptions written -- and hasn't heard reports of unusual smells, a spokeswoman says.

Ms. Jaskot also says Web sites that collect complaints about drugs "are doing the public a disservice." If consumers have problems with their medications they should "tell their physician, tell the manufacturer, tell the pharmacists, tell the FDA -- that's the only way these can get acted on and evaluated for veracity," she says.

But what if you complain to the FDA and are told, in effect, that your concerns are insignificant? As with so many other areas in health care, consumers have to be their own regulator and their own chief advocate.

"Consumers need to know that there are variations between generic drugs and brand-name drugs, and from one generic drug to another," says Wayne Pines, a former FDA spokesman who now consults for drug companies. "This is an area in which the patient has to be really self-protective, to be sure that they are getting the therapeutic effect that is best for them."

If you are taking a medication for a long-term condition, Mr. Pines advises staying with the version you are stabilized on. Some pharmacies sell generic versions interchangeably; tell your pharmacist you want to stay with the same one.

Monitor Symptoms

If you need to switch to a generic from a brand name for cost reasons, monitor your symptoms and review them with your doctor. Assess whether it's worth it to you to pay more. (There are some medications, particularly for thyroid and blood conditions, in which substitutions are never advised.)

The Graedons also recommend asking for copies of your lab reports, so you can help your doctor monitor any changes in your condition.

Be alert to changes in smell or appearance of your medications. Tell your doctor, pharmacist and the manufacturer if you notice anything odd.

Dr. Zealberg, however, is still waiting to hear back from the pharmacy that sold his patient blank pills.

Write to Melinda Beck at HealthJournal@wsj.com5

URL for this article:
http://online.wsj.com/article/SB120882069010332969.html
++++++++++++++++++++++++++++++++++++++++

It seems that Nardil isn't the only drug to which a change was made that has altered the drugs efficasy for some yet the change was considered within the 'tolerances' allowable by the FDA regs.

To bad those analyzing the change ('old' versus 'new' nardil) weren't depressants on nardil whose future was determined by nardil's efficasy as opposed to chemists with nothing on the line but a paycheck and supervisors whose opinions may be influenced by drug lobbyists or politicians.
   (Tue Apr 22 12:13 2008)

Inexact Copies: How Generics Differ From Brand Names April 22, 2008; WSJ Page D1

Joe Zealberg, a psychiatrist in Charleston, S.C., prescribed generic drugs to patients for years and rarely had problems -- until last year. A number of patients who had done very well on brand-name medications "crashed and burned" when they switched to generics, he says.
One woman "went from being perfectly fine to crying inconsolably 24 hours a day" after she switched from one generic antidepressant to another, Dr. Zealberg says. Another patient was sold a generic version of his attention-deficit drug that contained no identifying markings whatsoever -- a violation of federal rules.
Ten of his patients switched to a new generic version of the antidepressant Wellbutrin, but eight of them changed back, saying they felt anxious or shaky or their depression had returned. Several complained that the generic drug had a bad smell, he says.
Generic medications have been a boon to consumers around the world, allowing millions to buy lifesaving drugs for pennies a day. Some 65% of all prescriptions dispensed in the U.S. are for generics, though they account for only 20% of the dollars spent, according to the Generic Pharmaceutical Association.
While there is no hard evidence of growing problems from generics, consumers and physicians are increasingly concerned as cost pressures push more patients away from brand-name drugs. At the same time, the globalization of pharmaceutical manufacturing has revealed regulatory lapses.
By law, generics must have the same active ingredient and the same action as the brand-name version, which allows them to piggyback on the original safety and efficacy trials. But generics do have different inactive ingredients, which can affect how they are absorbed into the body. Generics can produce blood levels as much as 20% below or 25% above that of the original drug and still be considered "bioequivalent," according to Food and Drug Administration guidelines.
Some patients are more sensitive to those differences than others, and people who experience problems with medications are advised to contact their doctors, the drug manufacturer and the FDA's MedWatch. But as an FDA report last week on generic Wellbutrin revealed, consumers who complain may not get much satisfaction.
Wellbutrin, made by Biovail Corp. of Canada and marketed by GlaxoSmithKline PLC, is one of the best-selling antidepressants in the U.S., with sales of $1.8 billion in 2006. The FDA approved a generic version of Wellbutrin XL 300, a long-acting once-daily version, in December 2006. The generic, named Budeprion XL 300, soon accounted for roughly 40% of the one million monthly prescriptions for the antidepressant.
But patients soon started logging complaints about Budeprion at PeoplesPharmacy.com, a Web site that has become a clearinghouse for medication gripes. "We've received hundreds of complaints about generic drugs in general. But with this one drug, all of a sudden -- kaboom -- right after it was approved," says Joe Graedon, a pharmacologist who runs People's Pharmacy with his wife. Readers' postings cite side effects such as tremors, headaches, anxiety and sleep disturbances. Some consumers said their depression had returned, in some cases bringing thoughts of suicide. Many reported that their adverse effects stopped when they returned to the brand-name drug.
Mr. Graedon alerted the FDA. He also asked ConsumerLab.com, which normally runs tests for dietary supplement manufacturers, to compare Budeprion and Wellbutrin. Using a test-tube test that some industry experts question, ConsumerLab found that Budeprion dissolves faster, releasing 34% of the drug within the first two hours, compared with 8% for Wellbutrin.
"If you get four times the drug in the first two hours, that's too much drug in the beginning and not enough for the rest of the day," says Mr. Graedon, who worries that what he calls "dose dumping" could cause seizures, a concern with the brand-name drug as well.
Complaints about Budeprion also were coming into the FDA -- at least 130 from December 2006 to January 2008, according to Andy Georgiades of Dow Jones News Service, who filed a Freedom of Information Act request. Only four complaints were filed about two rival generic versions of Wellbutrin XL 300 that went on the market in June 2007.
FDA Investigates-
The FDA conducted an investigation and reported last week that although there were "small differences" between the two formulations, "they are not outside the established boundaries for equivalence." The generic did reach its maximum blood concentration in two to three hours, compared to five to six hours for Wellbutrin, but the FDA said those differences "were not considered clinically significant."
What accounted for the consumer complaints? The FDA cited "the natural history of depression," in which some patients have a recurrence of symptoms even while on medication.

Con't on next message....   (Tue Apr 22 12:03 2008)