Posted by jrbecker on September 1, 2004, at 15:53:33
In reply to Re: Chemist or Anyone, new Nardil not working » SLS, posted by luther on August 31, 2004, at 22:55:32
McMan's latest newsletter actually ran a story on the trouble over the new Nardil formulation....
McMan's Depression and Bipolar Weekly
Aug 24, 2004 Vol 6 No 20........
New Nardil
Elizabeth (not her real name) writes:
"On December 3, 2003, I picked up my prescription [for Nardil] at the pharmacy. When I arrived at home I noticed that the pills were different in appearance. Not knowing if I had been given the wrong prescription I went back to the pharmacy and was told by the pharmacist that Pfizer was now manufacturing Nardil and had changed the coating."
Within a week, Elizabeth began experiencing panic attacks, memory lapses, slurred speech, unsteady gait, constant crying, depression, and periods of depersonalization and disassociation.
"Somehow, I managed to get through the holidays," she went on to say. "In January of 2004 my symptoms became more intense and I just sat in my room and cried all the time. My psychiatrist was on vacation and in all honesty I never attributed what was happening to the medication. I believed that I had a brain tumor, dementia or Alzheimer's and made an appointment with a neurologist. After examining me thoroughly, he assured me that I was not suffering from any of the aforementioned and he believed it had something to do with the medication. By the time I saw my psychiatrist several days later I was suicidal and had to be hospitalized to come off the Nardil. I had to wait one week to start another MAOI, Parnate, which took close to four months to fully work. It does not work as well as the original Nardi,l but at least I am able to function and do things once again."
Elizabeth wasn’t the only Nardil patient who experienced an unpleasant surprise. Reports Sarah (not her real name): "It was like I wasn't taking an antidepressant at all. I couldn't understand why I was so very depressed when I was taking a strong antidepressant. I experienced crying jags, and felt general malaise. In addition, I had headaches and memory problems that made me think I was an Alzheimer's candidate."
Nardil is an MAOI inhibitor approved for treating depression in 1959. Because of its burdensome side effects, it is generally a medication last resort. But being relegated to the end of the queue (except for treating atypical depression) has created a ‘last shall be first" situation in the eyes of many who see this drug as their salvation. Reports Anonymous: "I was at the end of my rope and didn't care if I took arsenic if it would help me feel better. So I started taking it and after three days I felt a lot better, after that it was absolutely like a miracle. I felt human again and sooo good. I hadn't felt that good in years and years. I went around the house dancing and singing praises ... it felt so good to feel good. No words could describe it ... like going through hell on earth for years and then to feeling good, alive for the first time. I thanked God constantly for the miracle I had been praying for."
Nardil used to be produced by Warner-Lambert, and on more than one occasion the company had quality control issues with the drug, which resulted in FDA action. In 2000, Pfizer acquired Warner-Lambert, and late last year, with FDA approval, changed the inert ingredients to the drug without notifying doctors and pharmacists. Many patients experienced a worsening of their depression, and some cynically noted that they now required extra doses at additional cost to achieve the same previous benefit.
After hearing from Nardil patients, this writer contacted Pfizer with an emailed list of detailed questions. Following is Pfizer’s response in full:
According to IMS Health data from the period of July 2002 -June 2004, 183,392 total scripts were written for Nardil in the United States.
Pfizer has received a very limited number of complaints from both physicians and patients since the switch of the formulation. All are fully evaluated.
In all cases where Pfizer has received complaints relating to product, the company addresses the issue and upon closing of the case issues a letter to the individual as long as contact information is available.
We observed an increase in the number of complaints immediately after the reformulation was introduced, followed by a steady decline. This trend is consistent with other products which have undergone a formulation change. Pfizer continues to monitor and review all complaints and forward them to the FDA.
Since the approval of Nardil in 1959, the FDA has updated its regulations based on advances in manufacturing and testing technology. To ensure that the product would continue to comply with new regulations, a modification of the existing formulation was necessary. Pfizer submitted data to the FDA that show that the old and new formulation are bio-equivalent, and that the new formulation is more stable than the old. Based on these data, the FDA approved the new formulation.
Pfizer adheres to all applicable laws and regulations related to submission of adverse events.
All batches of the reformulated product are subject to stringent quality control tests during and after manufacturing. The batches in question met all of the specifications and no quality issues existed. Where complaints against specific batches were received the manufacturing records were checked to verify total compliance.
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