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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 6 of 6. This is the beginning of the thread.
Posted by halcyondaze on January 21, 2007, at 15:30:11
<< http://www.consumeraffairs.com/rx/pfizer_nardil.html >>
Judy of Fairfax Station VA (3/4/04):
This complaint is regarding a medication, Nardil, that Pfizer reformulated and then called it a labeling change. Last Oct.-Nov., I and many other patients went to their pharmacies to pick up their Nardil medication, only to find out that the medicine had been adjusted in some way. It smelled different, looked different, and none of the pharmacists, or physicians had been notified of the change.Many patients started to get depressed on the new Nardil, and had no clue why it was happening, the physicians were not certain what they were dealing with either. I, myself, went into a severe depression for a month, as did many, many other patients. Finally, my psychiatrist suggested increasing the dosage because he had no other ideas what to do. The dosage was raised from 75 mg., to 135 mg., which is a high dosage. The maximum recommended dosage is 90 mg.
I had all kinds of side effects, tremors, legs shaking, bad nightmares, etc. So, the dosage was decreased to 120 mg., and that is the dose I am on today.
Many patients are having horrible problems with this new Nardil. As far as I know, there were no clinical trials, they just changed the medication, called it a labeling change, and then sent it out to all these unsuspecting patients.
Some are severely depressed, suicidal, panicky, etc. because these patients have been through many other anti-depressants (which were not effective) and Nardil is the only drug that really works for them. And then Pfizer decides to change the excipients in the medication, and send the Nardil over to France to be manufactured, where I am assuming the FDA cannot monitor the manufacture of the drug, etc.
I am not a professional in the medical field, but I have taken this medicine for 22 year, and I know how it works, the side effects, how quickly it works when it's doing what it's supposed to, etc. And this new Nardil is working no more than 60-70% as well as the old Nardil. That is why I am having to double the dose, which also exposes me to more severe side effects, and of course, it is more expensive, because I have to take more for it to work.
I am speaking for myself, but I am also speaking for others who are too sick or too discouraged to write. One more thing, when the new Nardil was put into the pharmacies last fall, patients were calling pharmacies, calling Pfizer, calling anyone they could think of to try and buy the old Nardil. Calls were made to Australia, Canada, England, Mexico, because that is how frantic these patients were, at having to take an unfamiliar drug, that their doctor knew nothing about, etc.
Patients are writing their Congressmen, Senators, Pfizer, FDA, contacting lawyers, to see if there could be a lawsuit that would force Pfizer to make the old Nardil. There are patients now, openly talking about suicide.
Catherine of Goldens Bridge NY (3/3/04):
I have been taking the medication NARDIL since 1988 for severe panic disorder and depression. When I picked up my prescription in November 2003 I noticed that the pill looked different (coating was different, color a different shade) so I, wanting to make sure that I had the right medication, asked the pharmacist why the pill was different. He informed me that NARDIL was now being manufactured by Pfizer in France.Within one week after starting this new prescription I began experiencing panic attacks, depression, crying continually, memory lapses, disassociation and depersonalization episodes. I was convinced that I was in the beginning stages of Alzheimer's or some form of dementia and went to my neurologist. After examining me he told me that I was fine and he felt that the symptoms I was experiencing were medication-related.
My psychiatrist who prescribes the NARDIL was out of town and I had another week before my appointment. So I went on the internet and found all of these other people were going through the same as me. I found out that Pfizer had changed the formulation of the medication and had not advised pharmacies or physicians nor had they updated the literature.
When I brought all of the literature to my doctor the following week he was outraged and by this time I was in such bad shape that I had to be hospitalized. I am off the NARDIL and have started a different medication but I still have episodes from time to time. Pfizer put me and so many others through emotional and physical hell but why should they care since NARDIL is not a big seller like Prozac, Zoloft, Paxil, etc. I lost four months of my life, my holidays were ruined since I had no motivation and was continually crying and Pfizer should be held accountable for what it has done to all of the people whose lives have been affected.
Victoria of Wyoming MI (3/2/04):
Pfizer has altered the supposed 'inert' ingredients for their anti-depressant NARDIL (phenelzine sulfate) which treats generalized anxiety/depression, BUT only applied to the FDA for a 'labeling change' without doing any further testing on the new version. Apparently, the FDA says this is okay, because they allow it for the production of 'generics.' HOWEVER - with generics, the original drug is always still available, and in this case, it is NOT. The NEW VERSION is not working for many.While Pfizer may have the legal right to do this, I believe they have acted in an irresponsible manner towards their consumer base who depends on the original (now non-existent) drug for a comfortable existence. They have, in essence, replaced their original drug with a 'generic,' without informing the consumer, the physician or the pharmacist, while misleading the FDA by simply applying for a 'labeling change.' (which was approved.
This drug is not working in the efficent manner it had prior to the alterations; it is metabolizing differently and is causing many NARDIL users to suffer the results of the ingredient alterations; new side effects for which there was no clinical trial, and an overall lessening of the effectiveness of the drug. Further, while Pfizer is busy fighting Canadian Drug companies who attempt to see to US citizens, complaining that the FDA cannot regulate same, they are manufacturing THIS drug (Nardil) in FRANCE, over which country the FDA has no control!
It is entirely inappropriate for a company to offer a drug to the public for many years (since 1959, I believe) that addresses symptoms effectively, only to alter it in a way that has proven to be inadequate. The sticking point is that ONCE OFFERED, it is irresponsible to the point of disregard for human life and quality of life to REMOVE SAID MEDICATION from the market by altering it without running adequate tests. Their ONLY REASON for said alterations, according to Pfizer, is 'to prolong shelf life.'
Physical damage ranges from physical and emotional discomfort to a complete return of the symptoms that the drug is supposed to address. The consequences for many are potentially life-threatening - if an anti-depressant does not perform to capacity, those who experience a return of symptoms may well resort to self-damaging behaviour. Since anxiety is a part of what this medication addresses, and it has been caused to recur in many consumers, one might forsee that possible death could result from such alterations and lack of effectiveness.
As it stands, many have had to increase their dosages beyond adviseable limits in order for the drug to work; this can also result in incapacity up to and including death. New side effects including the horrific taste of the new coating (which dissolves instantly, while the original was hard-shell coating) and accompanying nausea, increased urinary retention, vomiting, general malaise, increased appetite beyond the original drug, flatulance, fetid diarrhoea and recurrence of both anxiety and depression are some personal and reported issues (online communications with others suffering from the 'new' formulation.)
Nardil Problems Activism:
<< http://www.stratguitar.com/nmember/nardil.php >>
Comments?
Posted by stargazer on January 21, 2007, at 17:05:56
In reply to Consumer complaints about 'new' Nardil:, posted by halcyondaze on January 21, 2007, at 15:30:11
Reminds me of what happened to me in 1992 when Roche discontinued making Marplan for financial reasons. There was no reformulation, just a letter to pdoc to wean their patients off Marplan, followed by my subsequent crash. I had been stable for about 2 years on it and it was thought that switching over to a new drug would be no big deal. Well it messed me up BIG Time and I have not forgotten it. Recently, Marplan was released after many years. I told my pdoc I wanted to try it since I thought it could work again. Of course it was totally useless since the formula had been changed.
Now hearing this about Nardil has me very upset since I have been thinking the next drug I should try might be Nardil since it worked once and might be worth trying again.
All of these decisions are made for the drug companies benefit, never with patient care in mind! I would continue to fight for the old formula to be reinstituted if there's any chance of that happening again.
Posted by blueberry1 on January 21, 2007, at 18:09:38
In reply to Consumer complaints about 'new' Nardil:, posted by halcyondaze on January 21, 2007, at 15:30:11
Wow. Heavy duty. I mean, real heavy duty. Scary stuff.
While the experts at the FDA walk around with their arrogant beauracratic superiority, this brings their true idiocy into the spotlight for all to witness.
People can, and may have, died from this. Suicide. Overdose. Side effects. While the FDA supposedly protects people from harm, they have ignorantly allowed a very dangerous thing to happen.
While most of the fingers seem to be pointing at Pfizer, I think an equal amount need to be pointed at the FDA as the governing body of all that goes on in the medication industry, especially when it comes to issues of efficacy and safety.
This also highlights why I do not trust generic medicines.
Posted by Phillipa on January 21, 2007, at 21:19:44
In reply to Re: Consumer complaints about 'new' Nardil:, posted by blueberry1 on January 21, 2007, at 18:09:38
No generics for me either they vary one way or the other by 20%. A huge amount. Various fillers. Love Phillipa
Posted by UgottaHaveHope on January 21, 2007, at 23:45:23
In reply to Re: Consumer complaints about 'new' Nardil: » blueberry1, posted by Phillipa on January 21, 2007, at 21:19:44
I thought this was done a long time ago. Seems from talking to some on Nardil on this board, it is working just fine for them.
Posted by polarbear206 on January 22, 2007, at 10:24:15
In reply to Re: Consumer complaints about 'new' Nardil:, posted by stargazer on January 21, 2007, at 17:05:56
It's no suprise to me. How many things has the FDA kept from the public?? I hear about this all the time being a psychiatric nurse.
This is the end of the thread.
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