Old Nardil (pre-2003)

The Issue

Old Nardil vs. New Nardil Comparison: Was The Old Version More Effective?

Please Vote Yes To Change Back To The Old Nardil.

Those who were taking the “old Nardil” (an MAOI antidepressant) formulation for depression know that it worked quite well. Many people had taken it for years, in some cases decades with relief from depressive symptoms. Although this drug didn’t work for everyone, those who found it effective usually experienced long-lasting relief from depression. As noted in 2003, the manufacturing of the drug was sold from the company Parke-Davis to Pfizer.

The original Nardil contained 15 ingredients and a slower release compared to the newer one which is a quicker release with only 9 ingredients. Currently there are no formulations in the United States that are the same as the “old” Nardil formula. Initially when complaints began to surface, Gavis Pharmaceuticals decided to manufacture Phenelzine (generic Nardil) to provide an alternative for those upset with the Pfizer variant.

The Gavis “brand” of generic Nardil is regarded by many as being the closest to the old formula in regards to ingredients and absorption. However, efficacy compared to the Pfizer version is still up for debate. Most people do still regard the old version created by Parke-Davis as being the best formula. Besides the Pfizer “name brand” version of the drug, there is only one other generic formula created by Greenstone LLC (a subsidiary of Pfizer); this contains the same inactive ingredients as the Pfizer version.

Old Nardil (Parke-Davis) vs. New Nardil (Pfizer)
Below is a comparison of the old version of the drug with the newer version. Understand that although only the inactive ingredients were modified, these modifications affected many people taking the drug.

Old Nardil (pre-2003)
In comparison to the newer version of the drug, this older version had more ingredients that contributed to a harder shell casing of the pill. You can compared the ingredients listed below to the ones associated with the new formula.

Manufacturer: Parke-Davis

Ingredients:

Acacia NF, Calcium carbonate, Carnauba wax NF, Corn starch NF, FD and C yellow No. 6, Gelatin NF, Kaolin USP, Magnesium stearate NF, Mannitol USP, Pharmaceutical glaze NF, Povidone USP, Sucrose NF, Talc USP, White wax NF, White wheat flower
Absorption: It is thought that the older version of Nardil took considerably longer to get broken down in the system. This is believed to have a lot to do with the outer-coating of the drug, which was thought to be superior in this pill design.

Efficacy: Superior. The efficacy of the old version is widely regarded by many as being superior to the new formula. Although not everyone will agree that the efficacy was superior, many found that they couldn’t tolerate the medication after the newer version was released.

Peak plasma levels: The peak plasma concentration for the old Nardil was thought to occur between 2 and 4 hours after someone took their dose. This falls in line with the absorption theory and the fact that the outer coating takes longer to dissolve than the newer version.

Pill Design: The older version of the pill had a hard, shiny candy-like coating; resembling an M&M. This has a lot to do with the inactive ingredients, which are thought to influence absorption of the drug. This older version is thought to take considerably longer to get broken down once ingested.

Long-term success: Many people who had been on the older Nardil noticed that they could keep taking the drug for years to treat depression without problems. Once they began to take the new pill, they noticed that it stopped working, never worked, and/or pooped out. There are reports of people who had taken Nardil for decades that could no longer tolerate it once the pill formula changed.

New Nardil (2003 – Present)
This newer version of Nardil was released by Pfizer in the fall of 2003. As you can see, the ingredients have changed. Several of the inactive ingredients were removed and replaced.

Manufacturer: Pfizer

Ingredients:

Mannitol USP, Croscarmellose sodium NF, Povidone USP, Edetate disodium USP, Magnesium stearate NF, Isopropyl alcohol USP, Purified water USP, Opadry orange Y30-13242A, Simethicone emulsion USP
Absorption: Some have hypothesized that the new Nardil is absorbed before actually reaching the small intestines. Even if it is not absorbed before reaching the small intestine, many believe that once the drug reaches the small intestine, the absorption may be disproportionate and unbalanced, inevitably leading to poorer responses from users.

Efficacy: Reduced. Many people began to notice a decline in tolerability and efficacy of this newer version of Nardil. Although this contained the same active ingredients at the old version, the inactive ingredients clearly played a role in influencing the way the drug was absorbed and tolerated.

Peak plasma levels: The peak plasma concentration for the new Nardil was thought to occur approximately 45 minutes after someone took their dose. This follows reports from people who say that the new version of Nardil seems as though it dissolves in the mouth if it isn’t swallowed immediately.

Pill Design: The coating of the new Nardil is considerably softer and is engraved with “PD 270.” It is noticeably less shiny and looks less like a candy M&M than the last version. Many believe it is the outer shell that played a role in contributing to the decline in efficacy. It’s very easy to tell the difference between this pill and the older version.

Side effects: Many people have noted many unwanted side effects associated with the newer version of the drug. Prior to the new drug, many agreed that the side effect profile was relatively manageable. As soon as the new drug hit the market, many people began to notice changes in how they were responding to the drug.

Theory:  Below is one theory that has been circulating around a few years following the inception of the new version.

The new Nardil is regarded by some as being problematic due to the fact that it dissolves quickly in the stomach, which allows too much of the drug to get filtered through the liver as opposed to getting absorbed by the small intestine. This would result in significantly less of the active ingredient to travel through the bloodstream and ultimately reach the brain; resulting in minimized antidepressant effects.

Additionally, the newer version of the drug could be introducing larger quantities of the active ingredient (phenelzine) to get filtered through the liver, which would result in increased levels of phenylethylamine (PEA). The level of PEA would become too high and less PEA would get destroyed as a result of MAO-B inhibition. The increase in PEA would result in increases in levels of dopamine and stimulation of dopamine receptors.

The dopamine in the brain could potentially reach high levels – perhaps too high for those dealing with depression and/or anxiety. The problem with the new Nardil is perhaps a lack of inhibition of MAO-A and MAO-B, could be raising dopamine levels at a ratio considerably greater than that of serotonin and norepinephrine, resulting in poorer responses from depression and anxiety sufferers.

 
Consumer Complaints: The newer version of the drug made by Pfizer came with a backlash of complaints from consumers. Many people on forums and message boards began to file complaints against this new version of the drug. This gained the attention of Gavis Pharmaceuticals who attempted to make a version of the drug closer to the old Nardil. Unfortunately many people did not find the Gavis version of the drug as effective as the older version as the ingredients still did not match the old formula.

Why did Pfizer change the Nardil pill in 2003?
An FDA report from Pfizer indicates that only inert buffering ingredients were changed. Despite the relatively minor changes, many people believe that it doesn’t dissolve the same as the old pill (it dissolves more quickly) and has a worse taste. Minor changes to the inactive ingredients have lead many to believe that the new version is considerably less effective.

Pfizer claimed they made these changes to Nardil to increase the drug’s shelf life. Their argument was that the newer version of Nardil still contains the same active ingredients, so these changes shouldn’t matter. As many people learned, the inactive fillers used in drugs can sometimes play an important role in influencing how the body absorbs and responds to the drug.

Upset consumers argue that Pfizer’s real motivation for changing the drug was likely to save money by utilizing cheaper manufacturing methods. Additionally many have stated that the claims made in regards to extending shelf life are completely false.

Note: A minority of individuals have considered that the ingredient change may have been due to the fact that companies were advised against using ingredients that contained gluten in medications.

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This petition had 15 supporters

The Issue

Old Nardil vs. New Nardil Comparison: Was The Old Version More Effective?

Please Vote Yes To Change Back To The Old Nardil.

Those who were taking the “old Nardil” (an MAOI antidepressant) formulation for depression know that it worked quite well. Many people had taken it for years, in some cases decades with relief from depressive symptoms. Although this drug didn’t work for everyone, those who found it effective usually experienced long-lasting relief from depression. As noted in 2003, the manufacturing of the drug was sold from the company Parke-Davis to Pfizer.

The original Nardil contained 15 ingredients and a slower release compared to the newer one which is a quicker release with only 9 ingredients. Currently there are no formulations in the United States that are the same as the “old” Nardil formula. Initially when complaints began to surface, Gavis Pharmaceuticals decided to manufacture Phenelzine (generic Nardil) to provide an alternative for those upset with the Pfizer variant.

The Gavis “brand” of generic Nardil is regarded by many as being the closest to the old formula in regards to ingredients and absorption. However, efficacy compared to the Pfizer version is still up for debate. Most people do still regard the old version created by Parke-Davis as being the best formula. Besides the Pfizer “name brand” version of the drug, there is only one other generic formula created by Greenstone LLC (a subsidiary of Pfizer); this contains the same inactive ingredients as the Pfizer version.

Old Nardil (Parke-Davis) vs. New Nardil (Pfizer)
Below is a comparison of the old version of the drug with the newer version. Understand that although only the inactive ingredients were modified, these modifications affected many people taking the drug.

Old Nardil (pre-2003)
In comparison to the newer version of the drug, this older version had more ingredients that contributed to a harder shell casing of the pill. You can compared the ingredients listed below to the ones associated with the new formula.

Manufacturer: Parke-Davis

Ingredients:

Acacia NF, Calcium carbonate, Carnauba wax NF, Corn starch NF, FD and C yellow No. 6, Gelatin NF, Kaolin USP, Magnesium stearate NF, Mannitol USP, Pharmaceutical glaze NF, Povidone USP, Sucrose NF, Talc USP, White wax NF, White wheat flower
Absorption: It is thought that the older version of Nardil took considerably longer to get broken down in the system. This is believed to have a lot to do with the outer-coating of the drug, which was thought to be superior in this pill design.

Efficacy: Superior. The efficacy of the old version is widely regarded by many as being superior to the new formula. Although not everyone will agree that the efficacy was superior, many found that they couldn’t tolerate the medication after the newer version was released.

Peak plasma levels: The peak plasma concentration for the old Nardil was thought to occur between 2 and 4 hours after someone took their dose. This falls in line with the absorption theory and the fact that the outer coating takes longer to dissolve than the newer version.

Pill Design: The older version of the pill had a hard, shiny candy-like coating; resembling an M&M. This has a lot to do with the inactive ingredients, which are thought to influence absorption of the drug. This older version is thought to take considerably longer to get broken down once ingested.

Long-term success: Many people who had been on the older Nardil noticed that they could keep taking the drug for years to treat depression without problems. Once they began to take the new pill, they noticed that it stopped working, never worked, and/or pooped out. There are reports of people who had taken Nardil for decades that could no longer tolerate it once the pill formula changed.

New Nardil (2003 – Present)
This newer version of Nardil was released by Pfizer in the fall of 2003. As you can see, the ingredients have changed. Several of the inactive ingredients were removed and replaced.

Manufacturer: Pfizer

Ingredients:

Mannitol USP, Croscarmellose sodium NF, Povidone USP, Edetate disodium USP, Magnesium stearate NF, Isopropyl alcohol USP, Purified water USP, Opadry orange Y30-13242A, Simethicone emulsion USP
Absorption: Some have hypothesized that the new Nardil is absorbed before actually reaching the small intestines. Even if it is not absorbed before reaching the small intestine, many believe that once the drug reaches the small intestine, the absorption may be disproportionate and unbalanced, inevitably leading to poorer responses from users.

Efficacy: Reduced. Many people began to notice a decline in tolerability and efficacy of this newer version of Nardil. Although this contained the same active ingredients at the old version, the inactive ingredients clearly played a role in influencing the way the drug was absorbed and tolerated.

Peak plasma levels: The peak plasma concentration for the new Nardil was thought to occur approximately 45 minutes after someone took their dose. This follows reports from people who say that the new version of Nardil seems as though it dissolves in the mouth if it isn’t swallowed immediately.

Pill Design: The coating of the new Nardil is considerably softer and is engraved with “PD 270.” It is noticeably less shiny and looks less like a candy M&M than the last version. Many believe it is the outer shell that played a role in contributing to the decline in efficacy. It’s very easy to tell the difference between this pill and the older version.

Side effects: Many people have noted many unwanted side effects associated with the newer version of the drug. Prior to the new drug, many agreed that the side effect profile was relatively manageable. As soon as the new drug hit the market, many people began to notice changes in how they were responding to the drug.

Theory:  Below is one theory that has been circulating around a few years following the inception of the new version.

The new Nardil is regarded by some as being problematic due to the fact that it dissolves quickly in the stomach, which allows too much of the drug to get filtered through the liver as opposed to getting absorbed by the small intestine. This would result in significantly less of the active ingredient to travel through the bloodstream and ultimately reach the brain; resulting in minimized antidepressant effects.

Additionally, the newer version of the drug could be introducing larger quantities of the active ingredient (phenelzine) to get filtered through the liver, which would result in increased levels of phenylethylamine (PEA). The level of PEA would become too high and less PEA would get destroyed as a result of MAO-B inhibition. The increase in PEA would result in increases in levels of dopamine and stimulation of dopamine receptors.

The dopamine in the brain could potentially reach high levels – perhaps too high for those dealing with depression and/or anxiety. The problem with the new Nardil is perhaps a lack of inhibition of MAO-A and MAO-B, could be raising dopamine levels at a ratio considerably greater than that of serotonin and norepinephrine, resulting in poorer responses from depression and anxiety sufferers.

 
Consumer Complaints: The newer version of the drug made by Pfizer came with a backlash of complaints from consumers. Many people on forums and message boards began to file complaints against this new version of the drug. This gained the attention of Gavis Pharmaceuticals who attempted to make a version of the drug closer to the old Nardil. Unfortunately many people did not find the Gavis version of the drug as effective as the older version as the ingredients still did not match the old formula.

Why did Pfizer change the Nardil pill in 2003?
An FDA report from Pfizer indicates that only inert buffering ingredients were changed. Despite the relatively minor changes, many people believe that it doesn’t dissolve the same as the old pill (it dissolves more quickly) and has a worse taste. Minor changes to the inactive ingredients have lead many to believe that the new version is considerably less effective.

Pfizer claimed they made these changes to Nardil to increase the drug’s shelf life. Their argument was that the newer version of Nardil still contains the same active ingredients, so these changes shouldn’t matter. As many people learned, the inactive fillers used in drugs can sometimes play an important role in influencing how the body absorbs and responds to the drug.

Upset consumers argue that Pfizer’s real motivation for changing the drug was likely to save money by utilizing cheaper manufacturing methods. Additionally many have stated that the claims made in regards to extending shelf life are completely false.

Note: A minority of individuals have considered that the ingredient change may have been due to the fact that companies were advised against using ingredients that contained gluten in medications.

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Petition created on August 31, 2016