I am much, much, better than I was six months ago but I am certainly far from being the person I was.  I can drive farther now and driving is easier but I don't like to be too far from home by myself.  Whatever they did to this formula; they certainly changed the way it works in most of our bodies.  I fear I will never be who I was before this as Nardil gave me a fulfilling life and I could do anything.
I think it might take several more months to get to that point.  I am so angry today; because they took my life away and after six months I am better and not so sick that I have to sit on the couch all day from the side effects but the progress is so slow and so gradual.     (Fri Feb 27 15:20 2004)

Say Judy,

I realize that having my last name on here means that lots of people have already seen it, and will continue to see it. I'll tell you what. Go ahead and send this  website then. I doubt that it matters very much if my last name is on here or not. Just please do not make it an excuse for leaving, since that is not my intention at all.

Yes, we would too band together for a law suit -- especially if we had a good case. I would and so would others.

"Also, I have taken Lithium for 20 years, it does a nice job of potentiating the effects of Nardil."

That's interesting to know, and it's also why I told Helen not to dismiss Lithium so quickly. It might well replace her Zyprexa and save her some serious problems now, and in the future.

"As far as Zyprexa goes, they just had a lawyer's ad on tv, asking if anyone had a relative, etc. that had been injured/died from the drug. Seems it would have been withdrawn from the market by now."

Yes, there have been some problems with this medication.

"I think this web site is wonderful for swapping info, but it appears unlikely that you guys are going to band together for a law suit, etc."

Wrong, at least on my part. I'd be happy to join up in a class action lawsuit.

"So, sayonara, guys, and good luck with Nardil, depressions, etc.(Thu Feb 26 22:52 2004)"

Please do not go, if my post is the reason. You seem to be genuinely interested in getting something done. That's extremely useful here, Judy.   (Fri Feb 27 17:07 2004)

Hello Catherine,

The max. dosage has not been changed, Kate, and I take 45 mg of the "new" Nardil. So, 90 mg is it, although I will wager you could push that higher without too much trouble, to say 120 mg., since this form does not appear to be as effective as the "old" form was. Acacia seems to me to be the most likely missing ingredient responsible for this. It's an MAOI in it's own right when it's mixed with another MAOI -- like Phenelzine Sulfate.

"My memory is still not right - no more lapses or disacciative episodes but forgetfullness - sometimes have trouble remembering what someone told me only ten minutes ago but my long term memory is still sharp."

I have had exactly the same memory problems since I first began taking Nardil in 1979. When I found it, and it actually worked, I thought I had finally hit the mother lode! Then, I realized that my short-term memory, which used to be excellent, was garbage. That was a huge disappointment too, and it remains one to this very day.

"I am going to see my grandchildren on Saturday - it's been six weeks - and I am both excited and anxious.  When I spoke to my grandson tonight he just kept telling me how much he missed me, how he loved me in the millions and was so excited that I was better and he was going to see me on Saturday."

It's great to hear that you are beginning to feel better, Kate. I'm glad that Parnate is finally starting to work for you. I see in your other post that you are using Xanax. I tried that for a while, but I finally had to go back to Valium, because it works much better for me.

"I had to fight back the tears when he told me that even when he becomes a big boy he will still come and see me every weekend. My granddaughter is and always has been very aloof. It's funny because I have two children - they are twins - my daughter was never a cuddly type baby and rarely shows compassion and is somewhat cold (like her father) while my son, who suffers from anxiety, panic attacks and depression was always affectionate."

Like mother, like son; like father, like daughter. Yes, that could certainly happen all right. And it could also flip flop in the next generation, since your daughter would likely marry someone who is more emotional than she is.

"Anyway Dave I hope you continue to improve and we both get our sense of reality back real soon."

Me too, but I need to help allot of other people, Kate. To that end, I am going to begin conducting some experiments on me!   (Fri Feb 27 18:02 2004)

Hello Cathy,

"I am much, much, better than I was six months ago but I am certainly far from being the person I was. I can drive farther now and driving is easier but I don't like to be too far from home by myself. Whatever they did to this formula; they certainly changed the way it works in most of our bodies."

Yes, they most certainly did. I still suspect acacia in particular. You see acacia, acts as MAOI when it is used in conjunction with another MAOI -- like Phenelzine Sulfate for example -- the active ingredient in Nardil. Notice how this Nardil seems weaker then the "old" Nardil was? Well, that might just explain it!

"I fear I will never be who I was before this as Nardil gave me a fulfilling life and I could do anything."

Well, don't give up just yet, because I still have some ideas cooking. I simply cannot promise anything yet, until I get the stuff and do the experimentation -- which will just happen to be upon me. It's not as though I have allot of volunteers for this exactly.

"I think it might take several more months to get to that point."

If you ever get there again on this Nardil, that will be just incredible, Cathy. I might just hold off in that case, since I am not especially fond of suffering needlessly. I will suffer for a good cause, but needlessly? Whoa!

"I am so angry today; because they took my life away and after six months I am better and not so sick that I have to sit on the couch all day from the side effects but the progress is so slow and so gradual. (Fri Feb 27 15:20 2004)"

Cathy, you have every right to be angry. All of us do, because our lives were suddenly changed for the worse. However, if you continue to improve, that is a very good sign indeed so keep it up and keep a journal of this so that you can refer to it later when you need to.   (Fri Feb 27 18:22 2004)

Hi Dave - Question:  If acacia is the missing link in metabolizing Nardil, can we
buy the stuff somehow and take it separately? Where would one buy acacia?
Thanks,
Helen    (Sat Feb 28 8:03 2004)

Helen...I am the one who originally brought acacia to Dave's attention.  There is one article I found on the web that talks about the bioactivity of acacia bark in a couple species of acacia.  However, after an exhaustive research on acacia as an excipient in drugs, I am unable to find any pharmacological literature that discusses acacia other than as a common excipient.  I'm beginning to feel that I might have overestimated its relevance.  You can order acacia gum (in huge amounts) from drug excipient companies, but I wouldn't advise you to do that until there is more evidence that it might actually do something.  I think it might actually be in chewing gum, but I'm not sure.    (Sat Feb 28 16:37 2004)

Paula -
Thanks for the info.
Helen
   (Sat Feb 28 17:02 2004)

Hello Helen,

Yes, Paula was indeed the person who uncovered the potential MAOI properties of Acacia. In the first post in which I discussed acacia, I indicated that Paula had discovered this for us. I have just gone back and attempted to find it, because I know it exists, but I did not see it. Still, it is there, and it has to have been posted by me within the last three days or so.

Given what Judy said about Lithium, before she left, and given what I read about Lithium before I answered your question, it seems as though you might want to substitute Lithium for Zyprexa. If it worked it would enhance Nardil's effects within you, and you would very likely not put on as such weight. Furthermore, you would avoid the potential diabetic problems that Zyprexa use bring with it. This, of course, is something you should discuss with your doctor, since he is supposed to be quite experienced in this field. I really wanted to tell this to you the other day, because I believe it might be very important to your well-being, Helen.

As for the medicinal properties of acacia, its effects actually depend upon which genus one is discussing. For example, Acacia berlandieri and Acacia rigidula are both West Texas species. Among the 40 or so alkaloids of these two plants, fully 5 are   natural amphetamines -- heretofore thought to be man-made chemicals only. I suppose my point is this: I would be very careful about selecting the genus of Acacia I was going to use in any medication.   (Sat Feb 28 20:09 2004)

I did a search today under lawsuits against walgreens, etc and I FOUND OUT THAT ATTORNEY GENERAL BLUMENTHAL MIGHT BE THE ONE PERSON THAT WILL LISTEN TO US.  HE IS THE ATTORNEY GENERAL FOR CONNECTICUT; HE HAS FILED A RULING AGAINST THE DRUG COMPANIES, PFIZER IS INCLUDED, WHO SAY THEY ARE NOT GOING TO SEE DRUGS TO CANADAIAN PHARMACIES WHO SELL TO CONSUEMRS IN THE U.S. HE SAYS THIS IS A HUGE VIOLATOIN OF CONSUMER PROTECTION LAWS...AND THE DRUG COMPANIES ARE NOT GOING TO GET AWAY WITHT HIS. I EMAILED HIM ABOUT GETTING THE SUBPOTENT BOTTLE OF NARDIL AND THAT PFIZER CHANGED THE FORMULA BUT TOLD THE FDA THEY ONLY REMOVED CORNSTARCH BUT WE HAVE PROOF THEY REMOVED 9 INGREDENTS..  PLEASE PLEASE TAKE 10 MINUTES AND SEND HIM AN EMAIL AND TELL HIM IF THE NEW FORMULA IS NOT WORKING FOR YOU AND THAT IT DID FOR ALL THE SO MANY YEARS YOU WERE ON THE FIRST NARDIL..  IT LOOKS LIKE HE MIGHT HELP US BASED ON CONSUMER PROTECTION LAWS. PLEASE YOU GUYS SEARCH UNDER ATTORNEY GENERAL BLUMENTHAL AND YOU WILL GET HIS EMAIL.!!!!   (Sat Feb 28 22:23 2004)

I have had no memory problems whatsoever with Nardil; having been on it 17 years now.  THE MAIN PROBLEM I HAVE IS GETTING THRU THE GD SIDE EFFECTS; IT LIKE I HAVE CANCER AND HAVE TO TAKE CHEMO AND LIVE THRU THE HELL; BUT SINCE MOST OF SIDE EFFECTS ARE GONE NOW; THANK GOD; I MIGHT GET MY LIFE BACK; OR 3/4 OF IT.  I DON'T KNOW WHAT ACACAIA HAS TO DO WITH THIS; BUT I DID READ IT ALL; PLEASE, PLEASE, PLEASE EMAIL ATTONEY GENERAL BLUMENTHAL AND PUT YOUR NAME AND PHONE; HE MIGHT BE JUST THE MAN WHO WILL LISTEN TO US AND LOOK INTO THIS.   (Sat Feb 28 22:30 2004)

Here is the email address for Attorney General Richard Blumenthal; PLEASE TAKE TIME TO EMAIL HIM; HE MIGHT LISTEN TO US; BE SURE TO STATE HOW THE NEW FORMULA HAS NOT WORKED FOR YOU AND THAT YOU KNOW THEY REMOVED 9 INGREDIENTS BUT SAY THEY ONLY REMOVED CORNSTARCH.  THIS COULD BE A VIOLATION OF CONSUMER PROTECTION LAWS BASED ON SOME OF THE LAWSUITS I HAVE SEEN THAT HE HAS FILED; PLUS THE FACT HE STATES IT IS A VIOLATION OF CONSUMER RIGHTS FOR PFIZER TO TRY TO STOP SELLING THEIR DRUGS TO CANADIAN PHARMACIES WHO SELL TO THE U.S. CITIZENS; WELL WHAT PFIZER HAS DONE TO US IS CERTAINLY A VIOLATION OF OUR RIGHTS PLUS THEY LIED TO THE FDA AND I CAN TELL YOU THAT THE BUCK DOES STOP WITH THE FDA; THE FDA AND PFZIER ARE NEVER GOING TO DO ANYTHING ABOUT THIS.   (Sat Feb 28 22:45 2004)

WEll shoot, I did paste it but now it is not there. For goodness sake...   (Sat Feb 28 22:46 2004)

   attorney.general@ po.state.ct.us  

there ya go; richard blumenthal...   (Sat Feb 28 22:48 2004)

Cathy and all,  The new prescription drug bill passed by Congress and supported by Pres. Bush makes it illegal for US citizens to buy drugs from Canada or any other country.  I don't know when the law takes effect.  I'm sure this isn't good news for AG Blumenthal's law suit.     (Sun Feb 29 9:44 2004)

Another interesting development.  Yesterday I received another letter from Pfizer.  This one asks for my "prescribing physician's" name, address and tel. so that they can speak with him about the Nardil problem. They say the letter is a result of my having contacted the FDA.  Why me?  My doc retired before the new Nardil appeared and knows nothing of the problem.  My internist now prescribes my Nardil but also knows almost nothing about the problem since I only see him once a year.  I wish they would have sent this letter to one of you who has a doctor to plead your case, so to speak.  This is just a form letter, but was signed by a Dr. of Pharmacology who is the Director of the Worldwide Safety Department at Pfizer.  Maybe you guys who contacted the FDA will get letters soon.  Once they start getting letters from doctors "supporting" us, assuming the doctors do support us, maybe we'll get somewhere.   (Sun Feb 29 10:05 2004)

Paula, of course it is against the law, but thousands of people in the US buy drugs from canada on line and continue to do so and no one has gone to jail yet.  Many people on this site get their Nardil from such places.  Also, someone from Pfizer did call me in December and asked me questions about the new Nardil and said she was sending my M.D. some paperwork to fill out. I assume he got it and he sent it back to Pfizer.  Another dead end as far as I know.  I have several letters from Pfizer and three from FDA; my file just keeps on growing.  Basically they say the same thing...if you make a report to the FDA that info goes to Pfizer and then Pfizer sends a letter that states...out products are blah blah blah and this is bioequivalent and FDA tested it.  Same garbabge over and over.   (Sun Feb 29 21:23 2004)

Cathy...No, currently buying drugs in Canada or from other countries is not illegal.  But, it will be illegal in the near future, whenever the new law takes effect. I don't know how they plan to monitor the internet but I used to order cigarettes from North Carolina over the net, then NY passed a law saying that you couldn't do that.  So now the company won't send them to me.  I have to have them sent to my sister in Ohio, where it's permitted, and then she sends them on to me.  But the new drug law will be a federal law, not a state law, so that sort of "getting around it" won't be possible.
Some senators and congressmen, particularly from the northern tier states, where senior citizens just drive over the border to fill their prescriptions, are quite upset about this part of the bill.  Whether they will have enough clout to change the bill I don't know.  I thought that Pres. Bush had already signed it, it which case it's a "done deal."   (Mon Mar 1 8:28 2004)

One more thing:  Although the bill's advocates use the "safety" issue as their reason for not allowing reimportation of drugs, the real reason, of course, is to protect the big drug company's bottom line.
This is one reason I've never been very optimistic about getting any real help from anyone in the government with our problem.  There are, of course, many honest and concerned Senators and Congressmen, they just don't have the power to do much.   (Mon Mar 1 8:45 2004)

I just found this web site and cannot believe what I am reading.  I have been taking Nardil for the past 4 years.  I started feeling bad in Nov.-Dec. 2003.  I just did not feel the same and could not figure it out.  I thought with Christmas and everything I  over worked myself, but in Jan.2004, I really was feeling bad.  I just had an appointment on Feb. 18, 2004 and the Dr. asked how I was feeling?  I told him I felt terrible, not the way I use to feel  He never said anything about the Nardil changing.  He just told me I could up the dose to 90mg..  Now after reading what you have said on this site, I understand why I am feeling the way I do, and NOT THE WAY THAT I USE TO FEEL.  I am upset with my Dr. that he never told me about the Pfizer Manufacturing Co. changing Nardil - I am sure he knew.

I understand now why I was having trouble-getting Nardil last year.  At the time, my Dr. told me Pfizer Manufacturing Co. was just having trouble manufacturing Nardil.

Glad I know the truth.  I will keep in touch.


I just called my Dr. about 1/2 hour ago and he just called me as I was getting ready to submit this note.  I cannot believe that he called me back so quick.  I am impressed.  I explained a little what you said in your responses and he said he knew nothing about the change.  He said they ( Pfizer) are always supposed to let the Physicians know about any changes.  He wants me to fax him the information so he can call Pfizer.
Hope something good comes out of this.  

I believe in God!!!!!!

   (Mon Mar 1 12:35 2004)

Dorothy...I'm glad you found your way here!  And I'm very happy that your doctor is going to call Pfizer!  That's what I've been waiting for!  Welcome!   (Mon Mar 1 19:13 2004)

Hello Paula,

It's not just you. I've gotten two such letters so far, but I truly do not feel obligated to cooperate with Pfizer any more.
They dropped my complaints so I just dropped their records, and as far as I am concerned, their records deserve to be goofed up the duration. It's time for some hardball, everyone.

Note: I fully realize this is petty.   (Mon Mar 1 22:46 2004)

Hello Dorothy,

Yes, Pfizer created a generic on us which -- guess what -- works differently that "old" Nardil did - and is not as effective. In fact, in some people it does not work at all.
Think about that one.

"He said they ( Pfizer) are always supposed to let the Physicians know about any changes. He wants me to fax him the information so he can call Pfizer.
Hope something good comes out of this."

Pfizer did not tell doctors or pharmacists for a very good reason. They didn't want to.
It would not suprise me if Pfizer aslo got special permission from the FDA -- something she can grant them. This so-called lable change is a complete overhaul of the medication.   (Mon Mar 1 22:54 2004)

Just found this on internet.


PRODUCT
Nardil Tablets (Phenelzine Sulfate Tablets, USP), 15 mg,
100 count bottles, Rx Only. Recall # D-082-4.
CODE
Lot number/Exp. Date: 90113L (11/2003), 91913L (11/2003), 92513L (12/2003), 92613L (12/2003), 24113L (12/2003), and 24213L (1/2004).
RECALLING FIRM/MANUFACTURER
Pfizer Inc., New York, NY, by letter on November 18, 2003 and November 20, 2003. Firm initiated recall is ongoing.
REASON
Subpotent: (stability).
VOLUME OF PRODUCT IN COMMERCE
95,933 bottles.
DISTRIBUTION
Nationwide, Canada, Spain, and South Africa.   (Tue Mar 2 0:41 2004)

This is a different recall than last time.  The last one was October 17, 2002.
Hope this is good news.
   (Tue Mar 2 0:44 2004)

Dorothy,  Since I'm still up late, I'll respond to your recall info.  We've seen those recall numbers.  If you notice the year of the dates, all expire 11&12 (2003) and 1 (2004).  These are bottles of the "old" Nardil.  Since I think their shelf life was 9 months, then these were manufactured in May & June, 2003.  Don't feel bad, though.  Everyone that comes here ends up finding that information. It's par for the course.   (Tue Mar 2 1:43 2004)

Well, actually earlier than May and June.  April and May, 2003.  The problem we think with the "new" Nardil is that except for the phenylzine, almost everything has been changed.  We don't know why this should make a difference in how we feel, but that's the only thing we can come up with.  You can find the new labeling for Nardil at the top of this page.  The old labeling has been written on this forum many times.  It also can be found on the FDA website if you search under Nardil.  There's a very big difference between the two.   (Tue Mar 2 1:52 2004)

Hello Dorothy, Welcome to our group; NO THE PHYSICIANS WERE NOT NOTIFIED OF A NEW NARDIL FORMULA; THERE IS NO LAW THAT SAYS ANYONE HAS TO BE NOTIFIED.  PFZIER MAKES A DRUG OR CHANGED IT THE FDA APPROVES IT AND THAT I LIFE.  I WAS TOLD IN DEC 2002 THERE MIGHT BE A SHORTAGE OF NARDIL DUE TO A MANUFACTURING PROBLEM; FIRST I WAS TOLD BY WALGREENS AND THEN MY M.D. TOLD ME; TOO BAD FOR ME THAT I DID NOT BUY IT AHEAD OF TIME AND STOCK PILE IT AS I GOT A SUBPOTENT BOTTLE THAT HAD BEEN RECALLED ON 8/31/03 BECAUSE WALGREENS DID NOT CHECK THE RECALLED LOT#, THEN I HAD TO START NARDIL ALL OVER AGAIN, AFTER TWO WEEKS OF CONSTANT PANIC ATTACKS AND SUICIDAL IDEATION WHEN MY M.D. AND I FIGURED OUT I GOT A BAD BOTTLE; WHEN I TOOK THE BAD BOTTLE BACK, AFTER ARGUING WITH THE PHARMACIST AS SHE SAID THE DATE WAS STILL GOOD, ETC ETC, I GOT A BOTTLE OF THE NEW FORMULA THAT HAD JUST COME OUT ON 9/15. ALL THE PEOPLE HERE KNOW THAT I HAVE BEEN VERY ILL FOR OVER SIX MONTHS DUE TO HAVING TO GO THOROUGHT THE NARDIL SIDE EFFECTS AGAIN AFTER BIENG ON THIS DRUG 16 YEARS.  LAST TIME I WAS ILL FOR 3 MONTHS FROM THE SIDE EFFECTS THIS TIME IT IS TAKING MORE THAN TWICE AS LONG AND THEY HAVE BEEN UNBEARABLE. SINCE NARDIL IS THE ONLY DRUG THAT WORKS FOR ME; I HAVE HAD NO CHOICE BUT TO LIVE WITH THIS.  I AM BETTER BUT I DON'T KNOW IF I WILL EVER BEE THE FULL FUNCTIONING PERSON I WAS ON THE OLD NARDIL.  AFTER SIX MONTHS OF MOST OF US MAKING REPEATED REPORTS TO PFIZER AND THE FDA WE SEEM TO HAVE ACCEPTED THAT PFIZER RUNS THE WORLD.  I WILL BE FILING A LAWSUIT DUE TO THE SUBPOTENT BOTTLE; BUT SO FAR PFIZER SEEMS TO BE ABLE TO DO ANYTHING THEY WANT TO DO; AND NO THE M.D.'S HAVE NOT BEEN TOLD IT WAS CHANGED.
ALSO SINCE PFIER STATES IT IS BIOEQUIVALENT AND APPROVED BY THE FDA, BOY IF I HAD $10.00 FOR EVERY TIME I HAVE HEARD THAT OR SEEN IT WRITTEN IN A LETTER TO ME; I COULD PROBABLY BUY A NEW CAR.   (Tue Mar 2 17:46 2004)

Hi, friends!
I've still been busy fighting Pfizer -- andt wanted to stop in and send a quick hug to all. I also wanted to encourage you folks, again, to continue being pro-active.

I just got off of the phone with Pfizer again. For me, the nausea/vomiting has gotten worse. I've also been low, and anxious. Started the new stuff in mid- November.)

SO - RECOMMENDING THE FOLLOWING - 1.)FILL OUT ANOTHER ONLINE MEDWATCH FORM, ALL OF YOU! I did so today... by going here:

http://www.fda.gov/medwatch/

and following online instructions -

ALSO - CALL PFIZER AND ASK FOR AN UPDATE! They DO keep your records. Let them know how you're doing!!!!!

BTW, I spoke to a Pfizer hotline pharmacist at THIS number
1-800-438-1985

at 7:30 PM Michigan time tonight -

- and, although I may sound suspicious -- he was pleasant up until the moment I mentioned MEDWATCH, he couldn't wait to get me off the phone... maybe because he had calls coming in, but the moment I mentioned it, he put me on hold to see if he had my MedWatch form, came back online to tell me he did, and then said "Thanks for calling" and was about ready to hang up. I must tell you I did NOT find that comforting. Until that point, he seemed willing to take down my new symptoms.

I also let him know I'd contacted anxiety organizations, Al Gore's wife, and anyone else I could find online that would respond to my emails.  That didn't seem to sit well with him either.

I was totally pleasant and kind - but insisted I wanted to hear from someone via telephone who was UPPER ECHELON PFIZER.

ADDENDUM - I got the original bottle from my pharmacist. Don't know if anyone here KNOWS this - but this drug is not even being PRODUCED in the U.S. It's being PRODUCED in France by Parke-Davis, and distributed by Pfizer/Parke-Davis US. This bottle is lot number 313051 which expires 1 Nov 04.

He also said that one only need send ONE pill to France, when I mentioned I can hardly afford to send my pills off for free -- AND had no response when I said "But you only produced 2 lots -- why can't you grab some of them and test them yourself?"

I also said "I am NOT disputing the Quality of the manufacture or ingredients - I am simply disputing the effectiveness of this 'NEW' Nardil.

So, PLEASE - call Pfizer back, all of you. Go fill out a new Medwatch form, even if you think none of this will do any good.

PLEASE!!!

Thanks and hugs,
Strat   (Tue Mar 2 20:07 2004)

To all, - HI ::big grin::

TO DAVE:
Since you are the epitomal inquiring mind, I wanted you (and the others) to know that my pharmacist actually handed me the empty bottle of Nardil with which he had filled my prescription yesterday. (Lot 3130501),  Just wanted to note that I have the accompanying  literature which is in most respects similar to the hyperlinked .pdf, with the following exceptions:

To begin with - here is the list of ingredients on the literature, which is the same as the hyperlink above with the omission of the crossed-out 'corn starch':
"NARDIL film-coated tablet for oral administration containes phenelzine sulfate equivalent to 15 mg of phenelzine base and the following inactive ingredients: mannitol, USP; croscarmellose sodium, NF; povidone, USP; edetate disodium, UPS; magnesium stearate, NF; isopropyl alcohol, UPS; purified water, USP, opadry orange Y30-13242A; simethicone emulsion, UPS."

Other than that, the only difference between what I have and the online .pdf is the number right below "Distributed by", which online is cited as
69-5895-00-1.1

and is on my insert as follows:

8805232
69-5985-00-3

Which I trust is the Revision

and the actual date of 'Revised May 2003'

Not much help, I'm sure, but just sharing.

ON THE BOTTLE:
is the number 1534, in a square blue box. Directly underneath that is "MADE IN FRANCE."

then the lot
LOT 3130501
EXP 1 NOV 04

The label, unlike the insert, has the identifier
05-5985-33-2
6705370

and

Store at 25 degrees C (77 degrees F); excursions permitted by 14-30 degrees C (59-86 degrees F)(see USP Controlled Room Temperature.)

Whatever any of that means, just reporting in. ::smile::

Warmly -
Strat   (Tue Mar 2 20:26 2004)

Me, third post. Has anyone seen this? This is a recall posting from January 21, 2004 on older lots of Nardil:
http://www.fda.gov/bbs/topics/enforce/2004/ENF0083

Now, in a friendly manner - I KNOW some of you are just plain FED UP with the FDA and with Pfizer.

But don't QUIT.  What Pfizer would be happy to think is that we're all going away. I told them tonight that I'm not going away until they fix this. :D

::the proverbial dog with bone::

PLEASE, just keep pestering, even if you feel it will do nothing.

hugs to all from Ms. Squeaky Wheel -

Strat (a/k/a Vicki)   (Tue Mar 2 20:48 2004)

My letter of this evening to the Ombudsman at the FDA, sharing for informational reasons. Will advise of his reply. (He DOES answer all of his email, if any of you choose to write.)
****************************
ombudsman@cder.fda.gov

Dear Mr. Rumble;

I am contacting you again with a further question about Nardil (phenelzine sulfate) for which Pfizer/Parke Davis applied for and received a 'labeling change' approval from the FDA.

Since I have had additional issues with this 'new' revision - and  have filled out 2 MedWatch reports on this drug (as have many others I've spoken with online who are suffering from the changes Pfizer made to this drug in late 2003.

I have 2 NEW sets of questions, please.

QUESTION SET ONE:
I have just discovered that this 'new' version of the drug, which has replaced the old, is being manufactured by Parke Davis in FRANCE, not in the U.S. How can the FDA can regulate such a drug, which is being distributed for use here in the U.S. by Pfizer/Parke-Davis? Is the FDA aware that the drug is being made overseas, and if so, why is that permissable?

QUESTION SET TWO:
2. Do the MedWatch forms become instantly accessible to the drug company? Isn't that a bit counterproductive? If I'm reporting what I consider inappropriate actions to YOU, then how is it that Pfizer told me they have my MedWatch reports? Did I indicate somewhere that you had my permission to share them with the drug company?

QUESTION SET THREE:
3. If by changing their inert ingredients, Pfizer has essentially replaced their original drug with a 'generic' of their own, without having the original one available any longer, and this drug is NOT WORKING for so many people, then WHAT recourse do any of us have, even if this creates a potentially life-threatening alteration of same? What recourse does the public have? There are many of us suffering, and each one feels so completely helpless. Since this drug is an anti-depressant that also addresses anxiety attacks, isn't it rather a dangerous situation not to escalate any reports on same?

So, really, to whom are we supposed to speak?
********************
strat   (Tue Mar 2 22:40 2004)

Fellow activists - go HERE to log a complaint to Consumer Affairs - no registration required...

http://www.consumeraffairs.com/php/a_report.php

Please help!
Strat   (Tue Mar 2 23:29 2004)

Strat,  Thanks for your, as usual, excellent work.  If you check the posts below you'll find what I consider to be two things to be optimistic about.  One is that Dorothy's doctor was upset when he discovered Nardil had been changed.  He said that doctors were supposed to be notified of those changes.  So he's contacting Pfizer.  The other was a post from Judy in which during one of her calls to Pfizer was told that the Nardil problem is being talked about there.  That's a good sign.  I most recently wrote a letter to Pfizer's Rocky Mountain Drug Center after being sent a letter asking for prescribing physician information.  Since my doctor knows nothing about the Nardil problem (my internist who I see once/year), I unfortunately couldn't give the letter to a doctor.  The letter said that it was in response to my having notified the FDA.  I hope others here get the same letter and can get their doctors to respond.  Anyway, just filling you in.   (Wed Mar 3 0:01 2004)

Strat, Yes, we did know that Nardil was made in France.  In fact, that's where I sent my sample.   (Wed Mar 3 0:02 2004)

Hi to Everyone,

It's been a few days since I've written and I hope that everyone is starting to feel somewhat like their old selves.  On Sunday I graduated to 20 mg of Parnate - still have extremely dry mouth and after the afternoon doseage I become very lethargic - hopefully these side effects will subside.  I am still experiencing perodically the symptoms of the NEW NARDIL and I wonder if I always have them.  So far I've contacted the consumer affairs website; the FDA, Pfizer again, my senators and congressmen.  Now let's see if they respond!  I am so angry that I've lost so much time, my holidays were ruined and most of all the time I lost with my grandchildren.  I did see them on Saturday and it was strained between my daughter and son in law.  I stayed for two hours and when I got ready to leave Scott and Emily were clinging to me and saying that they didn't want me to leave because they were afraid that I would get sick again and they wouldn't see me again.  It took me quite sometime to calm them down and assured them that I was getting better and we would be seeing each other all the time like before soon.  Of course, the drive home was filled with crying and sadness.  To add to my stress my father suffered a vascular stroke and he is totally out of it as far as trying to articulate words, is having outbursts and is frustrated.  My sister lives 100 miles away and my brother is no use so everything is on my shoulders when it comes to him.  

My doctor was outraged when I showed him what Pfizer had done to NARDIL and had not been NOTIFIED!  I have one of the most caring and compassionate doctor who truly cares about his patients.  I have been seeing him for 23 years and he has always been there for me and had helped me through some tough times, especially the NARDIL problem.  I am sure that he will write a letter if it is needed.  Nothing can ever give me back the suffering emotionally and physically I went through and for this I feel that Pfizer should compensate all of us for their shady practices.  They should spend less money advertising and more on improving their medications and communication procedures.  Pfizer shoulbe be held accountable for what they have done to all of us and who knows how many others.  If we continue our fight and don't give up (since that what they want us to do) possibly something good will come out of this.

Well, goodnight to everyone and hang in there - have faith and continue to fight.

Hello Strat (Vicki),

Both Paula and I were wondering how you were doing. I am truly sorry to hear that the nausea and vomiting have increased in frequency for you, rather than decreasing --something that side-effects usually but not always do after one has been taking a psychoactive drug for some time. Now, that would be enough to send me right on over the edge, I suspect.

I must confess that I have lucked out, and that my body has finally adjusted to the "new" Nardil very well. All I have to do is take a bit more -- an increase from 37.5 mg/day to 45 mg/day "new." I never have suffered through this so-called "wash-out" phase that others here have described, thank God. It is for that reason I questioned it some time ago, in fact.

So you were saying:

'To begin with - here is the list of ingredients on the literature, which is the same as the hyperlink above with the omission of the crossed-out 'corn starch':
"NARDIL film-coated tablet for oral administration containes phenelzine sulfate equivalent to 15 mg of phenelzine base and the following inactive ingredients: mannitol, USP; croscarmellose sodium, NF; povidone, USP; edetate disodium, UPS; magnesium stearate, NF; isopropyl alcohol, UPS; purified water, USP, opadry orange Y30-13242A; simethicone emulsion, UPS.'

Yes, this is a list of the excipients and active ingredient (Phenelzine Sulfate) of the "new" and generic Nardil, that is made in France for Parke Davis. Now remember that Pfizer is an international corporation so she very probably has a plant in France that is making this product for Parke-Davis -- a division of Pfizer. I have no idea how the manufacture of this drug is overseen, but there very likely is a way to do it.   (Wed Mar 3 13:27 2004)

Hello Paula,

I am still trying to come up with a substitute for the "new" Nardil, even though it works well enough in me. It's a tough nut to crack, but I have two ideas in mind that I will try. One might pan out: the other I am less optimistic about. Experimentation only will answer these questions.

I filled out Pfizer's form, but all they want to know is the name, rank and serial number of your doctor, which I dutifully supplied. I should send in two of them just to be ornery. Pfizer must get in touch with these doctors, unless the entire thing is a scam -- something which would not surprise me at all. This almost seems like a case of making certain all of the her records are in order.

"If you check the posts below you'll find what I consider to be two things to be optimistic about. One is that Dorothy's doctor was upset when he discovered Nardil had been changed. He said that doctors were supposed to be notified of those changes.  So he's contacting Pfizer."

I wish Dr. Nagel would do the same, but he is a veteran, and I suspect he knows what we are going up against. When I explained to him what had happened he simply attributed it to an inevitable corporation change. Dr. Feighner, a really big gun of the past, told me to keep on working with the "new" Nardil, which I have done and finally got right.

Please notice that Catherine's doctor is also angered by the degree to which this label change become a complete reformulation of the drug. In fact, however, the FDA can and does grant companies special permission to make some changes without any other information being required. Fast track!

"The other was a post from Judy in which during one of her calls to Pfizer was told that the Nardil problem is being talked about there. That's a good sign.  I most recently wrote a letter to Pfizer's Rocky Mountain Drug Center."

Pfizer's Rocky Mountain Drug Center should be close to me -- since I live right next door to those very mountains.

Strat, thanks again for listing Pfizer's hotline: 1-800-438-1985. I have called this one several times already, but a steady stream of phone calls might either result in some positive action, or they will change the number.   (Wed Mar 3 14:14 2004)

Part II

"I have one of the most caring and compassionate doctor who truly cares about his patients. I have been seeing him for 23 years and he has always been there for me and had helped me through some tough times, especially the NARDIL problem. I am sure that he will write a letter if it is needed."

It cannot hurt, although I do not believe Pfizer is ever going back to making their "old" formula. Many of those excipients are almost ancient they have been around so long. "Old" Nardil would not pass FDA approval today. One of these newer MAO-epinephrine drugs would, but not "old" Nardil. Which reminds me, that you might want to try one of these newer ones if Parnate and any other adjuncts do not work well enough for you.

"Nothing can ever give me back the suffering emotionally and physically I went through and for this I feel that Pfizer should compensate all of us for their shady practices. They should spend less money advertising and more on improving their medications and communication procedures. Pfizer shoul be held accountable for what they have done to all of us and who knows how many others. If we continue our fight and don't give up (since that what they want us to do) possibly something good will come out of this."

I must confess that it is giving me a crash course in how the FDA and large drug companies work. I do hope that you continue to improve and that the side-effects of Parnate, particularly that fatigue leaves you as soon as possible.   (Wed Mar 3 14:48 2004)

Part I

Hello Catherine,

"I am still experiencing perodically the symptoms of the NEW NARDIL and I wonder if I always have them."

I do not understand why exactly. You are no longer taking it, so it cannot be increasing in concentration in your vascular system and then your CNS. Perhaps it's just a residual reaction that will eventually disappear.

" So far I've contacted the consumer affairs website; the FDA, Pfizer again, my senators and congressmen. Now let's see if they respond!"

Indeed -- I wish someone would act for a change. That would be quite the surprise.

"I am so angry that I've lost so much time, my holidays were ruined and most of all the time I lost with my grandchildren. I did see them on Saturday and it was strained between my daughter and son in law. I stayed for two hours and when I got ready to leave Scott and Emily were clinging to me and saying that they didn't want me to leave because they were afraid that I would get sick again and they wouldn't see me again. It took me quite sometime to calm them down and assured them that I was getting better and we would be seeing each other all the time like before soon. Of course, the drive home was filled with crying and sadness."

As you feel better, you should forget some of your anger at Pfizer. I will not say it will go away entirely, for it has been a bitter experience for many of us.

"To add to my stress my father suffered a vascular stroke and he is totally out of it as far as trying to articulate words, is having outbursts and is frustrated"

This is unwelcomed news, Kate. I am terribly sorry to hear about it. I remember when my grandfather, who also had this illness, suffered a stroke, and he was never close to being the same man again. He became extremely surly to my Grandmother, which I did not understand as a child.

"My sister lives 100 miles away and my brother is no use so everything is on my shoulders when it comes to him."

Do the best that you can for him, but do not kill yourself in the effort. You cannot undo the damage this had done to his brain. Sorry about your sister and brother in particular.

"My doctor was outraged when I showed him what Pfizer had done to NARDIL and had not been NOTIFIED!"

Nobody was notified. This generic Nardil simply appeared one day when I went to have my prescriptions filled. Had I not been searching for better prices on Nardil, I never would have stumbled into this forum.   (Wed Mar 3 14:56 2004)

I am glad to see that someone's M.D. was upset; my M.D. said, in August, there is nothing I can do.  He had reported a drug interaction death to the FDA and nothing ever came of it.  I have three letters from three different people from the FDA; maybe that ombudsman can help; I have trashed the idea that Pfizer and the FDA give a shit about any of us.  It is all about money.
If the FDA approved it Pfizer can make the drug anywhere; it does not have to be made in the US; but had to be approved by the FDA to be sold here.  ALSO REMEMBER, PFIER LIED TO THE FDA, WITH THE WORD CORNSTRACH LINED OUT BUT REMOVED 9 INGRDEINTS.  I AM DOING MUCH BETTER BUT I DON'T LIKE TO DRIVE TOO FAR FROM HOME ALONE; I THINK THIS IS MORE THE FACT THAT I HAVE BEEN SO ILL FOR SO LONG AND FEAR NOT BEING ABLE TO GET BACK HOME.  IN TIME THIS WILL PASS, PRAY; I FEEL LIKE A 90 YO WOMAN.
DAMN PFIZER AND THE FDA IS STILL WHAT I SAY.   (Wed Mar 3 21:07 2004)

As far as any of us losing time here, I have lost six months of my life and sufferred more than I ever have from the side effects. They were so bad for so long I would not have cared if I had died; since they changed the formula and took out so many of the ingredients it really slammed me to the floor.  I have lost one year of college and would have received my Associate Degree in Human Services. Right now I don't even know if I will go back to school my life has been so torn up; I just thank God that I am not sick 24 hours  a day now and I can get out some and enjoy this fraction of what my life used to be.  I still don't know how Pfizer can get away with this but so far they have.   (Wed Mar 3 21:11 2004)

Hello Cathy,

"I am glad to see that someone's M.D. was upset; my M.D. said, in August, there is nothing I can do. He had reported a drug interaction death to the FDA and nothing ever came of it."

Both of the psychiatrists I have consulted are veterans of the mental illness wars. The oldest and best convinced me to continue working with "new" Nardil, and he turned out to be correct -- for me only. This is just plain luck or ineptness on my part though, since I failed to feel anywhere nearly this good in my first two trials. My present Psychiatrist would have been willing to switch me to Parnate after the urinary retention at 60 mg showed up. Fortunately, by the time I last saw him last, I had finally figured out how to get this Pfizer generic to work.

"I have three letters from three different people from the FDA; maybe that ombudsman can help; I have trashed the idea that Pfizer and the FDA give a shit about any of us. It is all about money."

I must grudgingly agree with this assessment. Pfizer only got hopping when those sub-potent bottles of the "old" formula turned up, and she finally realized that this medication is simply not prescribed as much as it once was by physicians.

"If the FDA approved it Pfizer can make the drug anywhere; it does not have to be made in the US; but had to be approved by the FDA to be sold here."

Agreed! As I said, Pfizer very likely has a plant in France that makes "new" Nardil for the Parke-Davis division - among other things.

"ALSO REMEMBER, PFIER LIED TO THE FDA, WITH THE WORD CORNSTRACH LINED OUT BUT REMOVED 9 INGRDEINTS."

Yes, she did, unless the FDA granted her a special favor which the FDA can and has done before to drug companies. This was no label change. It was a drug reformulation, and should have been handled like one.

"I AM DOING MUCH BETTER BUT I DON'T LIKE TO DRIVE TOO FAR FROM HOME ALONE; I THINK THIS IS MORE THE FACT THAT I HAVE BEEN SO ILL FOR SO LONG AND FEAR NOT BEING ABLE TO GET BACK HOME."

Here, I must regrettably disagree. It does not appear to me as though you are getting enough Norephinephrine (NE), or you would fairly easily resume your life. You would just be able to do it. I do not know exactly why you are not getting enough monoamine inhibition of NE enough, but I would wager everything that formulation change is the answer. Except for coming back here to check everyone out, I have. I am working with two other people who do not respond at all to the "new" Nardil.   (Wed Mar 3 22:52 2004)

Hello again Cathy,

"As far as any of us losing time here, I have lost six months of my life and sufferred more than I ever have from the side effects. They were so bad for so long I would not have cared if I had died; since they changed the formula and took out so many of the ingredients it really slammed me to the floor."

What I am about to say is an observation only. I mean this in no other way. Cathy, your body is just incredibly sensitive to this change in Nardil formulas. I have been taking the "new" stuff for a little bit less than a month, and while I have had to increase the dose by 0.5 tablets compared to "old" Nardil, I cannot tell any difference between the two -- anymore. Clearly, this was not I have always thought!

I still believe that your CNS is not just getting enough Norephinephrine (NE) to function with the same drive and desire again, which is what NE brings to the plate, along with it's anti-depressive properties, for some people.

"I have lost one year of college and would have received my Associate Degree in Human Services. Right now I don't even know if I will go back to school my life has been so torn up; I just thank God that I am not sick 24 hours a day now and I can get out some and enjoy this fraction of what my life used to be."

I do not know why you have not increased your dosages -- other than those dreaded side effects. Because if you did and you got over the side-effects you would be doing one heck of allot better.

"I still don't know how Pfizer can get away with this but so far they have.(Wed Mar 3 21:11 2004)"

Considering the age of this drug, and too few people who require it, Pfizer can do whatever she wants it seems. There is no sense kidding yourself into believing that she would not sacrifices all of us, if this problem went away.   (Wed Mar 3 23:07 2004)

Hello everyone,

I want to thank everyone for being so supportive and for the emails to send complaints.

  Sorry I have not been replying, but I have 4children 1 husband and do not have the time to always write.  I am trying to keep up with reading everyone’s emails and sending complaints in.  I am going to try to contact my Dr. to see if he has done anything about calling Pfizer yet.  Hope to have good news.

  
   (Thu Mar 4 6:45 2004)

So how is everyone doing? Can we be of further assistance?   (Fri Mar 5 0:53 2004)

Hi Everyone,

Something very interesting happened today.  The new health care insurance plan I have requires that I use their mail order program for maintenance prescriptions - you must order a 3 month supply and it usually takes the, 3 to 4 weeks to send it to you.

With all that has been going on with me I forgot that just before I realized it was the NEW NARDIL that was making crazy I mailed off my prescription.  Today it came and it qas 540 pills of the ORIGINAL NARDIL!
I actually became hysterical laughing when I opened it - what gives - for three months you take the original - then when they run out you take the new one - talk about ending up in a rubber room.  Also, as far as shelf life is concerned I was under the impression that all prescriptions had a shelf life of one year - if you look on any prescription bottle it tells you not to use it a year from the date it was filled - this I find confusing since how long was it laying in the pharmacy?

As far as the Parnate goes the morning pill 10mg is ok but the afternoon 10mg makes me extremely lethargic and I still have the dry mouth but my doctor says these side effects should pass. At least I am able to function and drive on the highway again, went out to dinner with some friends for my birthday, am cleaning and throwing out things in preparat ion for for selling the house but something is still not right.  I cannot feel any joy or happiness, I used to laugh a lot now it's an effort to smile.  I feel angry, bitter and want Pfizer to be held accountable for all pain and suffering we have endured and it frustrates me since I don't know how to make that happen soon enough.  I also worry about whether some other drug company will do the same thing with the Parnate - I just couldn't go through it again.

Hope everyone is feeling as best as they can.

Hello Catherine,

What do think that means that you received the ORIGINAL NARDIL?  What was the exp. date or wasn't there a exp. date?  Maybe there making the ORIGINAL NARDIL again.  I know that's to good to be true, just wishful thinking.
I am starting to feel a little better but I have increased my new nardil to 6 - 7 pills a day.  I know 7 is over the limit but if it makes me feel better I'm going to take it.  

As for not feeling happy and laughing that is my problem with this new nardil too.  I use to feel so good.  Get up every morning at 5:45 and get the kids up for school and make them a nice breckfast.  Since the new Nardil I can't get up and I feel like I could sleep all the time.  If I sit down in a chair I fall asleep.  Hope this gets better because my kids always don't understand.  (Sometimes my husband doesn't either - (most of the time).

Tried to reach my Dr. yesterday to see if he has done anything yet about calling Pfizer, (but he was't in) so maybe today I can reach him today.

HOPE FOR THE BEST !   (Fri Mar 5 9:06 2004)

Hello Catherine,

"Today it came and it qas 540 pills of the ORIGINAL NARDIL!"

Hey, we might be the only two people alive that have any of the "old Nardil. I always overbought on this medication though, so my some of mine is ancient. However, I have taken some of it, and it remains potent 4 years after being dispensed! What shelf-life problems was Pfizer having? I don't necessarily believe them.

"as far as shelf life is concerned I was under the impression that all prescriptions had a shelf life of one year - if you look on any prescription bottle it tells you not to use it a year from the date it was filled - this I find confusing since how long was it laying in the pharmacy?"

I can now say that the "old" Nardil has a shelf-life of at least 4 years. Moreover, I never got any sub-potent Nardil, although I know this problem existed since Cathy was nailed by it and lots were pulled. It would not surprise me to find that Pfizer changed formulations more to modernize the medication.

"As far as the Parnate goes the morning pill 10mg is ok but the afternoon 10mg makes me extremely lethargic and I still have the dry mouth but my doctor says these side effects should pass."

They will, Kate; they will. It takes at least one month to sort out the changes any single medication will bring and maybe longer.

"At least I am able to function and drive on the highway again, went out to dinner with some friends for my birthday, am cleaning and throwing out things in preparation for for selling the house but something is still not right. I cannot feel any joy or happiness, I used to laugh a lot now it's an effort to smile. I feel angry, bitter and want Pfizer to be held accountable for all pain and suffering we have endured and it frustrates me since I don't know how to make that happen soon enough."

You might well have a case against Pfizer, Kate, but most of us do not. The sad fact is that we simply have to bend over and take the new "worse" formula.

"I also worry about whether some other drug company will do the same thing with the Parnate - I just couldn't go through it again."

I would advise you to start building up a cache of Parnate in your freezer. Buy more than you need and rat-hole some of away. Also, if it will be exposed to oxygen over this period of time, use nitrogen to prevent oxidation instead. This is the second medication that has been radically changed on me. I am not taking any chances!   (Fri Mar 5 23:33 2004)

Hello Dorothy,

"Maybe there making the ORIGINAL NARDIL again. I know that's to good to be true, just wishful thinking."

No such luck or I would be all over that stuff, and so would about 50 people I know. Like Catherine, I do have some old Nardil rat-holed away, though. I suppose it's going to finally become subpotent -- one day. But it's not now that much I do know since I have been taking it until the last three months. Fortunately, I did make the transition over the new, which was really rough (took me three tries, with the second ending in failure and completely urinary retention), but now I do believe I have it down, even though this medication is a worse one by far. It's just not as potent.

"I am starting to feel a little better but I have increased my new nardil to 6 - 7 pills a day. I know 7 is over the limit but if it makes me feel better I'm going to take it."

By all means, do. Do not force yourself to suffer -- unless the cost of not doing so is great enough.

"As for not feeling happy and laughing that is my problem with this new nardil too. I use to feel so good. Get up every morning at 5:45 and get the kids up for school and make them a nice breckfast. Since the new Nardil I can't get up and I feel like I could sleep all the time. If I sit down in a chair I fall asleep. Hope this gets better because my kids always don't understand. (Sometimes my husband doesn't either - (most of the time)."

1. There is no question this formulation is not has good as the "old" One was.
2. Do not expect normal people to understand your illness. They really do not understand it -- including many doctors I have met.
3. Dorothy, I truly do hope you do start to feel more "pop" on the "new" formula. You might want to drink some coffee in the morning if you do not already do so. It saved me for years.

"Tried to reach my Dr. yesterday to see if he has done anything yet about calling Pfizer, (but he was't in) so maybe today I can reach him today."

I hope so, but unless we get some incredibly publicity we are never going to change Pfizer's mind. Moreover, I am now certain that the "old" Warner-Lambert, Lakeside Pharmaceutical formulation would pass FDA approval today. This is one of the biggest reasons why Pfizer changed Nardil, really.

"HOPE FOR THE BEST !"

Always!

However, prepare for the worst! It never hurts a bit to be prepared for emergencies, like drug company chemical changes. Had I known.........   (Fri Mar 5 23:59 2004)

Does anyone else need any help? Or are well all in good shape now?
   (Sun Mar 7 0:00 2004)