Label Revisions are as Simple as This
May 20, 2017 13:43:58 GMT -5
sla55, mpg54, and 5 more like this
Post by mango on May 20, 2017 13:43:58 GMT -5
The truth is, you do not have to conduct a present day clinical trial or even have relevant present day patient data for the FDA to approve label revisions. Decade old epidemiological data and review papers apparently are sufficient enough—
• The FDA recently (2016) made a huge warning label revision on all Metformin containing products by approving its use for patients with mild-moderate kidney impairment, which was previously a Metformin serious life-threatening adverse event associated with the drug. The concern was over high risks for developing severe lactic acidosis with Metoformin use in these patients. This would previously apply to patients with renal and CVDs (shock, infections, acidosis, MIs. cerebral haemorrhage, PVD, stroke, etc...). The FDA based thier decision on this in 2016 by literally reviewing 12 publications concerning Metformin which only included review papers and epidemiological studies. No modern clinical trial data relevant to the decision whatsoever. I laugh.
Pluck the feathers from the wings of death? Or just corrupt and greedy? Eh, I'll go with both.
• If acidosis is extrememly rare and hardly an issue in these patients then conduct the necessary clinical trial or provide relevant present day results and data to prove it. Not BS. Don't give me decade old publications written by paid shills when you STILL do NOT even know the damn MOA of the drug. What a joke.
• So, according to the FDA, this is within the current standards they use for label revisions. For Metformin that is. ALL Metformin containing drugs' warning labels were revised. See something wrong with this? I do.
• I will provide you with some of my favorite excerpts from just one of these review papers the FDA used to come to their decision. Enjoy.
—I believe Afrezza received the same judicious labeling and careful monitoring of adverse events because of the recent negative realities with Exubera. There's an arguement, run with it.
—The responses concerning Afrezza about how "the clinical trial data" hasn't shown/proven xyz—eat your words because this example of the FDA revising Metformin's warning label involving a life threatening adverse event was based off of ZERO relevant clinical trial data or evidence. Epidemiology studies, review articles, and rants. This alone throws that excuse out the window. Shills.
• So they even admit they have no idea what the hell Metformin actually does. That's my takeaway because it is true.
• What will the FDA do when the data becomes overwhelming that Metformin causes neurodegenerative diseases? It will become the most significant event in all of history.
• This is exactly why knowing the MOA is crucial and of utmost importance. This is elementary common sense which the FDA severely lacks. There is and always will be an alternative motive. Just look at this one. The FDA literally relied on shit like this to revise the warning labels on all Metformin containing drugs of a life-threatening adverse event associated with the medication. Literally changed the warning label on all of Metformin containing products and deemed it acceptable for patient use based off biased rants with zero substance which is evidenced in those quotes from one of them.
• The FDA also just recently withdrew the Black Box Warnings for Chantix (and the other generic forget name), but that decision was based off of an actual real life, modern day clinical trial.
—A smoking cessation PATCH that will NEVER require chronic use had to go through a CLINICAL TRIAL to revise its Black Box Warnings.
—Metformin, a drug that chronically destroys the human body, gets high fives for submitting review articles and epidemiological data and reviews to get a FDA favorable warning revision on all Metformin containing products.
I can't accept this as my reality. Everything needs to change. It is a slow process but it has already begun.
• Zero adverse events have been reported since the approval of Afrezza. Zero patients have been admitted to the ER and/or hospital from using Afrezza. Afrezza is non-toxic and does not cause amyloidosis. Afrezza is the safest diabetes medication in the world.
MannKind can succeed—Real time data. Real time results. Real time proof. Real time questions. One real time answer. Afrezza.
• The FDA recently (2016) made a huge warning label revision on all Metformin containing products by approving its use for patients with mild-moderate kidney impairment, which was previously a Metformin serious life-threatening adverse event associated with the drug. The concern was over high risks for developing severe lactic acidosis with Metoformin use in these patients. This would previously apply to patients with renal and CVDs (shock, infections, acidosis, MIs. cerebral haemorrhage, PVD, stroke, etc...). The FDA based thier decision on this in 2016 by literally reviewing 12 publications concerning Metformin which only included review papers and epidemiological studies. No modern clinical trial data relevant to the decision whatsoever. I laugh.
Pluck the feathers from the wings of death? Or just corrupt and greedy? Eh, I'll go with both.
• If acidosis is extrememly rare and hardly an issue in these patients then conduct the necessary clinical trial or provide relevant present day results and data to prove it. Not BS. Don't give me decade old publications written by paid shills when you STILL do NOT even know the damn MOA of the drug. What a joke.
• So, according to the FDA, this is within the current standards they use for label revisions. For Metformin that is. ALL Metformin containing drugs' warning labels were revised. See something wrong with this? I do.
• I will provide you with some of my favorite excerpts from just one of these review papers the FDA used to come to their decision. Enjoy.
A common clinical conundrum faces all U.S. practitioners treating patients with type 2 diabetes. Today’s U.S. Food and Drug Administration prescribing guidelines for metformin contraindicate its use in men and women with serum creatinine concentrations ≥1.5 and ≥1.4 mg/dL (≥132 and ≥123 µmol/L), respectively.
In a patient tolerating and controlled with this medication, should it automatically be discontinued as the creatinine rises beyond these cut points over time?
How many patients are unable to receive this medication on the basis of guidelines which, although well intentioned, are somewhat arbitrary and outdated based on modern assessments of renal status?
Despite these proven benefits, metformin remains contraindicated in a large segment of the type 2 diabetic population, largely because of concerns over the rare adverse effect of lactic acidosis.
Other contraindications (e.g., any significant hypoxemia, alcoholism, cirrhosis, a recent radiocontrast study) also increase the risk for or the consequences of lactic acidosis, but these are not the topic of this review.
Metformin was not approved in the U.S. until December of 1994 and was marketed in 1995. The experience with phenformin led to judicious labeling and recommendations for careful monitoring of adverse events. Its new-drug application was the subject of extensive review.
—I believe Afrezza received the same judicious labeling and careful monitoring of adverse events because of the recent negative realities with Exubera. There's an arguement, run with it.
—The responses concerning Afrezza about how "the clinical trial data" hasn't shown/proven xyz—eat your words because this example of the FDA revising Metformin's warning label involving a life threatening adverse event was based off of ZERO relevant clinical trial data or evidence. Epidemiology studies, review articles, and rants. This alone throws that excuse out the window. Shills.
Moreover, whether measurement of metformin levels actually can aid in the prediction of lactic acidosis risk remains unclear. Therefore, although these studies provide some information on the relationship between renal function and metformin concentrations, they do not clarify the issue of toxicity and lactic acidosis risk.
Although lactic acidosis remains a recognized, albeit rare, adverse event associated with metformin, the number of lactic acidosis cases continues to be very small, particularly when one considers the widespread use of this drug.
Given the current contraindications in the U.S., some might consider it a challenge to conduct a new clinical trial to evaluate the use of metformin in individuals with various degrees of impaired renal function, taking into account new criteria for assessing glomerular filtration. Yet, evidence suggests that metformin is often already used in practice outside of the current labeling contraindications, prescribed in full knowledge of the relevant cutoffs (38–41).
Thus, the long-proclaimed causal relationship between metformin and lactic acidosis remains in question.
• What will the FDA do when the data becomes overwhelming that Metformin causes neurodegenerative diseases? It will become the most significant event in all of history.
• This is exactly why knowing the MOA is crucial and of utmost importance. This is elementary common sense which the FDA severely lacks. There is and always will be an alternative motive. Just look at this one. The FDA literally relied on shit like this to revise the warning labels on all Metformin containing drugs of a life-threatening adverse event associated with the medication. Literally changed the warning label on all of Metformin containing products and deemed it acceptable for patient use based off biased rants with zero substance which is evidenced in those quotes from one of them.
• The FDA also just recently withdrew the Black Box Warnings for Chantix (and the other generic forget name), but that decision was based off of an actual real life, modern day clinical trial.
—A smoking cessation PATCH that will NEVER require chronic use had to go through a CLINICAL TRIAL to revise its Black Box Warnings.
—Metformin, a drug that chronically destroys the human body, gets high fives for submitting review articles and epidemiological data and reviews to get a FDA favorable warning revision on all Metformin containing products.
I can't accept this as my reality. Everything needs to change. It is a slow process but it has already begun.
• Zero adverse events have been reported since the approval of Afrezza. Zero patients have been admitted to the ER and/or hospital from using Afrezza. Afrezza is non-toxic and does not cause amyloidosis. Afrezza is the safest diabetes medication in the world.
MannKind can succeed—Real time data. Real time results. Real time proof. Real time questions. One real time answer. Afrezza.