Re: Re: FDA Medwatch Adverse Event Reporting System

[Guest guest]

Almost ALL of us have reported to MedWatch AND petitioned, there system moves to slow without the media involved. We've been doing this for the last decade and it took 10 years just to hold a board meeting!!!!!!!!!!!!!!!!!!!!!!!!To: miralax Sent: Wed, December 7, 2011 7:14:10 AMSubject: Re: FDA Medwatch Adverse Event Reporting System

FDA has the Medwatch reporting system for adverse events....

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049087.htm

If everyone on this yahoo group submitted in the same week, I think it would make an impact. Carol

We need to find someone who knows how to do an online petiton that each person can sign like they do with the political parties to send to the FDA and the President of the United States

To: miralax Sent: Tue, December 6, 2011 8:43:36 PMSubject: Re: Jeanie's research

How do you suggest I gather everyone's issues? Do your letters address them all or just the one's you've experienced? I could go back through all the messages, but it would take too much time. If you have them already listed, that would be great. Carol

Carol ChittendenEmpire State Consumer Project, Inc.http://empirestateconsumerproject.blogspot.com/Please consider the environment before printing this email.

Please do Carol, any help is appreciated..................You should see if your company would be interested in picking up the case...............MANY parents will come forward, we just need a voice..........I've petitioned the FDA twice with one with no response? A gentlemen at the FDA taught me how, his name is Koningstein 1-800-FDA-1088

To: miralax Sent: Tue, December 6, 2011 7:48:58 AMSubject: R e: Jeanie's research

Wow, I really want to read all this - working today, but will get to it in the next couple of nights.

I found you through a search I was doing in preparation for a colonoscopy, which I have postponed, but am also with Empire State Consumer Project (http://empirestateconsumerproject.blogspot.com/- we have been in the news lately for finding arsenic in apple juice. We sent our results to Consumer Reports who did their own testing and published it this week. We petitioned the FDA for limits on arsenic in juices and they are finally looking at setting guidelines. We also work on heavy metals in toys and children's jewelry pesticides, and many other toxics issues. Judy Braiman, ESCP president was instrumental in getting the FDA take Rely tampons off the market when women were getting TSS from them in the 80's. Would it help at all if we filed a complaint with the FDA? I am so passionate about Miralax now after hearing what so many children are going through. I'm sure most of you have already filed complaints, but thought maybe it would help to compile all the adverse events into one letter and send it from our group if it would help move the FDA forward in any way. If things are already on course and their look at Miralax is progressing, that's great. I just wanted to offer if more help is needed. Carol

thank you for sharing that! Here they are..............you have to pay for the FOIA Freedom of Information Act, AERS reports. I've been studying this medication since 2001 and submitted every 6 months to begin my own study and the numbers went from 6 to 1,966 in 10 years. The cost is $55.00 and now went up to $65.00. The FDA also held a drug oversight board meeting on the side effects of PEG in pediatrics..........see enclosed 6 files + 1 drug oversight board meeting link. There is also an article titled fatal disnatremia caused by elective colonoscopy. 2 out of 3 adult patients died from an elective colonoscopy using PEG electrolyte solution. The author writes that the death and morbidity wouldn't have happened UNLESS they had the unappreciated presence of C-diff or escheria coli............this tells me they know something about if there's bad bacteria in the colon, that something can go very wrong, yet I haven't come across ONE individual that knows a thing about it. Below and attached is a decade of research I've spend to find out the truth about this medication b/c I knew something went REALLY WRONG upon giving this medication to my dd......................

Drug oversight board meeting

Replies to Fatal dysnatraemia caused by elective colonoscopy

To: miralax Sent: Mon, December 5, 2011 8:08:28 PMSubject: Miralax Adverse Event Reporting to FDA

I was just looking up Miralax on the FDA site again and they only show adult reports. Aren't there reports from the group too?

http://www.drugcite.com/?q=miralax

Carol

[Guest guest]

I don't know how the whole system works but just as we have prosecuting attorneys in our justice system, I think they have their own attorney's that have to fight to correct any misjudgements they've approved and with the economy the way it is, I don't think anyone has the funds to correct anything at this time??????????? I would imagine it's like anything else in this world, they'll get to it when they can..............even though children have died............see

attachmentTo: miralax Sent: Thu, December 8, 2011 6:49:27 AMSubject: Re: Re: FDA Medwatch Adverse Event Reporting System

Almost ALL of us have reported to MedWatch AND petitioned, there system moves to slow without the media involved. We've been doing this for the last decade and it took 10 years just to hold a board meeting!!!!!!!!!!!!!!!!!!!!!!!!To: miralax Sent: Wed, December 7, 2011 7:14:10 AMSubject: Re: FDA Medwatch Adverse Event Reporting System

FDA has the Medwatch reporting system for adverse events....

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049087.htm

If everyone on this yahoo group submitted in the same week, I think it would make an impact. Carol

We need to find someone who knows how to do an online petiton that each person can sign like they do with the political parties to send to the FDA and the President of the United States

To: miralax Sent: Tue, December 6, 2011 8:43:36 PMSubject: Re: Jeanie's research

How do you suggest I gather everyone's issues? Do your letters address them all or just the one's you've experienced? I could go back through all the messages, but it would take too much time. If you have them already listed, that would be great. Carol

Carol ChittendenEmpire State Consumer Project, Inc.http://empirestateconsumerproject.blogspot.com/Please consider the environment before printing this email.

Please do Carol, any help is appreciated..................You should see if your company would be interested in picking up the case...............MANY parents will come forward, we just need a voice..........I've petitioned the FDA twice with one with no response? A gentlemen at the FDA taught me how, his name is Koningstein 1-800-FDA-1088

To: miralax Sent: Tue, December 6, 2011 7:48:58 AMSubject: R e: Jeanie's research

Wow, I really want to read all this - working today, but will get to it in the next couple of nights.

I found you through a search I was doing in preparation for a colonoscopy, which I have postponed, but am also with Empire State Consumer Project (http://empirestateconsumerproject.blogspot.com/- we have been in the news lately for finding arsenic in apple juice. We sent our results to Consumer Reports who did their own testing and published it this week. We petitioned the FDA for limits on arsenic in juices and they are finally looking at setting guidelines. We also work on heavy metals in toys and children's jewelry pesticides, and many other toxics issues. Judy Braiman, ESCP president was instrumental in getting the FDA take Rely tampons off the market when women were getting TSS from them in the 80's. Would it help at all if we filed a complaint with the FDA? I am so passionate about Miralax now after hearing what so many children are going through. I'm sure most of you have already filed complaints, but thought maybe it would help to compile all the adverse events into one letter and send it from our group if it would help move the FDA forward in any way. If things are already on course and their look at Miralax is progressing, that's great. I just wanted to offer if more help is needed. Carol

thank you for sharing that! Here they are..............you have to pay for the FOIA Freedom of Information Act, AERS reports. I've been studying this medication since 2001 and submitted every 6 months to begin my own study and the numbers went from 6 to 1,966 in 10 years. The cost is $55.00 and now went up to $65.00. The FDA also held a drug oversight board meeting on the side effects of PEG in pediatrics..........see enclosed 6 files + 1 drug oversight board meeting link. There is also an article titled fatal disnatremia caused by elective colonoscopy. 2 out of 3 adult patients died from an elective colonoscopy using PEG electrolyte solution. The author writes that the death and morbidity wouldn't have happened UNLESS they had the unappreciated presence of C-diff or escheria coli............this tells me they know something about if there's bad bacteria in the colon, that something can go very wrong, yet I haven't come across ONE individual that knows a thing about it. Below and attached is a decade of research I've spend to find out the truth about this medication b/c I knew something went REALLY WRONG upon giving this medication to my dd......................

Drug oversight board meeting

Replies to Fatal dysnatraemia caused by elective colonoscopy

To: miralax Sent: Mon, December 5, 2011 8:08:28 PMSubject: Miralax Adverse Event Reporting to FDA

I was just looking up Miralax on the FDA site again and they only show adult reports. Aren't there reports from the group too?

http://www.drugcite.com/?q=miralax

Carol

1 of 1 File(s)

children.pdf

[Guest guest]

Jeannie,

Oh good - I figured that had to have been happening, but came in so much later.

I'm starting to work on a letter from my consumer group. Can you tell me how many people are on this yahoo group? Carol

Almost ALL of us have reported to MedWatch AND petitioned, there system moves to slow without the media involved. We've been doing this for the last decade and it took 10 years just to hold a board meeting!!!!!!!!!!!!!!!!!!!!!!!!

To: miralax Sent: Wed, December 7, 2011 7:14:10 AMSubject: Re: FDA Medwatch Adverse Event Reporting System

FDA has the Medwatch reporting system for adverse events....

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049087.htm

If everyone on this yahoo group submitted in the same week, I think it would make an impact. Carol

We need to find someone who knows how to do an online petiton that each person can sign like they do with the political parties to send to the FDA and the President of the United States

To: miralax Sent: Tue, December 6, 2011 8:43:36 PMSubject: Re: Jeanie's research

How do you suggest I gather everyone's issues? Do your letters address them all or just the one's you've experienced? I could go back through all the messages, but it would take too much time. If you have them already listed, that would be great. Carol

Carol ChittendenEmpire State Consumer Project, Inc.http://empirestateconsumerproject.blogspot.com/Please consider the environment before printing this email.

Please do Carol, any help is appreciated..................You should see if your company would be interested in picking up the case...............MANY parents will come forward, we just need a voice..........I've petitioned the FDA twice with one with no response? A gentlemen at the FDA taught me how, his name is Koningstein 1-800-FDA-1088

To: miralax Sent: Tue, December 6, 2011 7:48:58 AMSubject: R e: Jeanie's research

Wow, I really want to read all this - working today, but will get to it in the next couple of nights.

I found you through a search I was doing in preparation for a colonoscopy, which I have postponed, but am also with Empire State Consumer Project (http://empirestateconsumerproject.blogspot.com/- we have been in the news lately for finding arsenic in apple juice. We sent our results to Consumer Reports who did their own testing and published it this week. We petitioned the FDA for limits on arsenic in juices and they are finally looking at setting guidelines. We also work on heavy metals in toys and children's jewelry pesticides, and many other toxics issues. Judy Braiman, ESCP president was instrumental in getting the FDA take Rely tampons off the market when women were getting TSS from them in the 80's. Would it help at all if we filed a complaint with the FDA? I am so passionate about Miralax now after hearing what so many children are going through. I'm sure most of you have already filed complaints, but thought maybe it would help to compile all the adverse events into one letter and send it from our group if it would help move the FDA forward in any way. If things are already on course and their look at Miralax is progressing, that's great. I just wanted to offer if more help is needed. Carol

thank you for sharing that! Here they are..............you have to pay for the FOIA Freedom of Information Act, AERS reports. I've been studying this medication since 2001 and submitted every 6 months to begin my own study and the numbers went from 6 to 1,966 in 10 years. The cost is $55.00 and now went up to $65.00. The FDA also held a drug oversight board meeting on the side effects of PEG in pediatrics..........see enclosed 6 files + 1 drug oversight board meeting link. There is also an article titled fatal disnatremia caused by elective colonoscopy. 2 out of 3 adult patients died from an elective colonoscopy using PEG electrolyte solution. The author writes that the death and morbidity wouldn't have happened UNLESS they had the unappreciated presence of C-diff or escheria coli............this tells me they know something about if there's bad bacteria in the colon, that something can go very wrong, yet I haven't come across ONE individual that knows a thing about it. Below and attached is a decade of research I've spend to find out the truth about this medication b/c I knew something went REALLY WRONG upon giving this medication to my dd......................

Drug oversight board meeting

Replies to Fatal dysnatraemia caused by elective colonoscopy

To: miralax Sent: Mon, December 5, 2011 8:08:28 PMSubject: Miralax Adverse Event Reporting to FDA

I was just looking up Miralax on the FDA site again and they only show adult reports. Aren't there reports from the group too?

http://www.drugcite.com/?q=miralax

Carol

[Guest guest]

1555 membersyou can always check by clicking on visit your group, it's in the lower left corner and changes daily, we created the group in 2004they started giving this to children in 1999upon receiving my first submission from the fda, there were only 6 other submissions before I submitted through MedWatch, so the numbers went from 6 to 1,966 in a decadeTo: miralax Sent: Thu, December 8, 2011 7:43:36 AMSubject: Re: Re: FDA Medwatch Adverse Event Reporting System

Jeannie,

Oh good - I figured that had to have been happening, but came in so much later.

I'm starting to work on a letter from my consumer group. Can you tell me how many people are on this yahoo group? Carol

Almost ALL of us have reported to MedWatch AND petitioned, there system moves to slow without the media involved. We've been doing this for the last decade and it took 10 years just to hold a board meeting!!!!!!!!!!!!!!!!!!!!!!!!

To: miralax Sent: Wed, December 7, 2011 7:14:10 AMSubject: Re: FDA Medwatch Adverse Event Reporting System

FDA has the Medwatch reporting system for adverse events....

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049087.htm

If everyone on this yahoo group submitted in the same week, I think it would make an impact. Carol

We need to find someone who knows how to do an online petiton that each person can sign like they do with the political parties to send to the FDA and the President of the United States

To: miralax Sent: Tue, December 6, 2011 8:43:36 PMSubject: Re: Jeanie's research

How do you suggest I gather everyone's issues? Do your letters address them all or just the one's you've experienced? I could go back through all the messages, but it would take too much time. If you have them already listed, that would be great. Carol

Carol ChittendenEmpire State Consumer Project, Inc.http://empirestateconsumerproject.blogspot.com/Please consider the environment before printing this email.

Please do Carol, any help is appreciated..................You should see if your company would be interested in picking up the case...............MANY parents will come forward, we just need a voice..........I've petitioned the FDA twice with one with no response? A gentlemen at the FDA taught me how, his name is Koningstein 1-800-FDA-1088

To: miralax Sent: Tue, December 6, 2011 7:48:58 AMSubject: R e: Jeanie's research

Wow, I really want to read all this - working today, but will get to it in the next couple of nights.

I found you through a search I was doing in preparation for a colonoscopy, which I have postponed, but am also with Empire State Consumer Project (http://empirestateconsumerproject.blogspot.com/- we have been in the news lately for finding arsenic in apple juice. We sent our results to Consumer Reports who did their own testing and published it this week. We petitioned the FDA for limits on arsenic in juices and they are finally looking at setting guidelines. We also work on heavy metals in toys and children's jewelry pesticides, and many other toxics issues. Judy Braiman, ESCP president was instrumental in getting the FDA take Rely tampons off the market when women were getting TSS from them in the 80's. Would it help at all if we filed a complaint with the FDA? I am so passionate about Miralax now after hearing what so many children are going through. I'm sure most of you have already filed complaints, but thought maybe it would help to compile all the adverse events into one letter and send it from our group if it would help move the FDA forward in any way. If things are already on course and their look at Miralax is progressing, that's great. I just wanted to offer if more help is needed. Carol

thank you for sharing that! Here they are..............you have to pay for the FOIA Freedom of Information Act, AERS reports. I've been studying this medication since 2001 and submitted every 6 months to begin my own study and the numbers went from 6 to 1,966 in 10 years. The cost is $55.00 and now went up to $65.00. The FDA also held a drug oversight board meeting on the side effects of PEG in pediatrics..........see enclosed 6 files + 1 drug oversight board meeting link. There is also an article titled fatal disnatremia caused by elective colonoscopy. 2 out of 3 adult patients died from an elective colonoscopy using PEG electrolyte solution. The author writes that the death and morbidity wouldn't have happened UNLESS they had the unappreciated presence of C-diff or escheria coli............this tells me they know something about if there's bad bacteria in the colon, that something can go very wrong, yet I haven't come across ONE individual that knows a thing about it. Below and attached is a decade of research I've spend to find out the truth about this medication b/c I knew something went REALLY WRONG upon giving this medication to my dd......................

Drug oversight board meeting

Replies to Fatal dysnatraemia caused by elective colonoscopy

To: miralax Sent: Mon, December 5, 2011 8:08:28 PMSubject: Miralax Adverse Event Reporting to FDA

I was just looking up Miralax on the FDA site again and they only show adult reports. Aren't there reports from the group too?

http://www.drugcite.com/?q=miralax

Carol