Re: Fwd: FDA petition on peg 3350

[Guest guest]

Well, Thank you Yvette, wait till you see all the attachments, we'll post them soon. To: miralax Sent: Sun, May 20, 2012 9:11:52 PMSubject: Re: Fwd: FDA petition on peg 3350



Congratulations to Jeanie & Carol & all that woked so very hard to make this happen!!

Yvette

Petition is sent! Please circulate freely> > FOR IMMEDIATE RELEASE:> > Polyethylene Glycol Laxatives May Prove Harmful to Children> > > Rochester, New York, May 15, 2012 - After an eight month review of research collected by a parent support group, http://health.groups.yahoo.com/group/miralax/, Empire State Consumer Project has submitted an FDA Citizen Petition on behalf of the group asking the FDA to investigate laxatives containing Polyethylene Glycol 3350 (PEG 3350) being prescribed to children.> > The support group’s co-founder, Jeanie Ward, has filed two FDA petitions over the last 10 years and has seen an FDA Drug Safety Oversight Board convened to discuss potential dangers to children without issuing warnings to doctors or parents, http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm171059.htm.> > The number of adverse events related (in any way) to Polyethylene Glycol 3350 filed with the FDA has risen from 7 in 2001 to 2,257 in 2012. Adverse events reported include kidney, digestive, and neurological events, including tics, extreme behaviors, aggression, violence, and death.> > Jeanie Ward started collecting adverse events and studies on PEG 3350 when she noticed changes in her daughter while taking a best-selling PEG laxative, Miralax. Doctors told her there was no connection. “I started doing my own research and ordering adverse events reports from the FDA, as often as every 6 months – and the numbers started soaring. After hundreds of adverse events, FDA’s response was “there is insufficient evidence to require an amendment of the product label at this time.â€> > Today the parent support group is host more than 1,600 members, mostly parents looking for information on the laxatives and guidance on natural protocols for treating their children’s constipation. Polyethylene Glycol laxatives are not approved by the FDA for use in children, but are being prescribed off-label to children as young as 2 months old.> > Polyethylene glycol is a petroleum based product and a relative of ethylene glycol, the key ingredient in antifreeze. Although some medical professionals deny a connection, parents are reporting symptoms similar to those seen with ethylene glycol poisoning. > > For more information on the petition contact Carol Chittenden, Empire State Consumer Project at cachitter@....> To reach Jeanie Ward, contact http://health.groups.yahoo.com/group/miralax/.> > > > > > > > > > >

[Guest guest]

HURRAY!!!!!!!!! Way to go, Jeanie and Carol! FOR IMMEDIATE RELEASE:Polyethylene Glycol Laxatives May Prove Harmful to ChildrenRochester, New York, May 15, 2012 - After an eight month review of research collected by a parent support group,http://health.groups.yahoo.com/group/miralax/, Empire State Consumer Project has submitted an FDA Citizen Petition on behalf of the group asking the FDA to investigate laxatives containing Polyethylene Glycol 3350 (PEG 3350) being prescribed to children.The support group’s co-founder, Jeanie Ward, has filed two FDA petitions over the last 10 years and has seen an FDA Drug Safety Oversight Board convened to discuss potential dangers to children without issuing warnings to doctors or parents,http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm171059.htm.The number of adverse events related (in any way) to Polyethylene Glycol 3350 filed with the FDA has risen from 7 in 2001 to 2,257 in 2012. Adverse events reported include kidney, digestive, and neurological events, including tics, extreme behaviors, aggression, violence, and death.Jeanie Ward started collecting adverse events and studies on PEG 3350 when she noticed changes in her daughter while taking a best-selling PEG laxative, Miralax. Doctors told her there was no connection. “I started doing my own research and ordering adverse events reports from the FDA, as often as every 6 months – and the numbers started soaring. After hundreds of adverse events, FDA’s response was “there is insufficient evidence to require an amendment of the product label at this time.”Today the parent support group is host more than 1,600 members, mostly parents looking for information on the laxatives and guidance on natural protocols for treating their children’s constipation. Polyethylene Glycol laxatives are not approved by the FDA for use in children, but are being prescribed off-label to children as young as 2 months old.Polyethylene glycol is a petroleum based product and a relative of ethylene glycol, the key ingredient in antifreeze. Although some medical professionals deny a connection, parents are reporting symptoms similar to those seen with ethylene glycol poisoning. For more information on the petition contact Carol Chittenden, Empire State Consumer Project at cachitter@....To reach Jeanie Ward, contact http://health.groups.yahoo.com/group/miralax/.Carol ChittendenBegin forwarded message:> Date: May 16, 2012 9:46:11 AM EDT> To: miralax > Subject: Petition is sent! Please circulate freely> > FOR IMMEDIATE RELEASE:> > Polyethylene Glycol Laxatives May Prove Harmful to Children> > > Rochester, New York, May 15, 2012 - After an eight month review of research collected by a parent support group,http://health.groups.yahoo.com/group/miralax/, Empire State Consumer Project has submitted an FDA Citizen Petition on behalf of the group asking the FDA to investigate laxatives containing Polyethylene Glycol 3350 (PEG 3350) being prescribed to children.> > The support group’s co-founder, Jeanie Ward, has filed two FDA petitions over the last 10 years and has seen an FDA Drug Safety Oversight Board convened to discuss potential dangers to children without issuing warnings to doctors or parents,http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm171059.htm.> > The number of adverse events related (in any way) to Polyethylene Glycol 3350 filed with the FDA has risen from 7 in 2001 to 2,257 in 2012. Adverse events reported include kidney, digestive, and neurological events, including tics, extreme behaviors, aggression, violence, and death.> > Jeanie Ward started collecting adverse events and studies on PEG 3350 when she noticed changes in her daughter while taking a best-selling PEG laxative, Miralax. Doctors told her there was no connection. “I started doing my own research and ordering adverse events reports from the FDA, as often as every 6 months – and the numbers started soaring. After hundreds of adverse events, FDA’s response was “there is insufficient evidence to require an amendment of the product label at this time.”> > Today the parent support group is host more than 1,600 members, mostly parents looking for information on the laxatives and guidance on natural protocols for treating their children’s constipation. Polyethylene Glycol laxatives are not approved by the FDA for use in children, but are being prescribed off-label to children as young as 2 months old.> > Polyethylene glycol is a petroleum based product and a relative of ethylene glycol, the key ingredient in antifreeze. Although some medical professionals deny a connection, parents are reporting symptoms similar to those seen with ethylene glycol poisoning. > > For more information on the petition contact Carol Chittenden, Empire State Consumer Project at cachitter@....> To reach Jeanie Ward, contact http://health.groups.yahoo.com/group/miralax/.> > > > > > > > > > >

[Guest guest]

Awesome work!!!

>

> > FOR IMMEDIATE RELEASE:

> >

> >

> > Polyethylene Glycol Laxatives May Prove Harmful to Children

> >

> >

> >

> > Rochester, New York, May 15, 2012 - After an eight month review of research

collected by a parent support

group,http://health.groups.yahoo.com/group/miralax/, Empire State Consumer

Project has submitted an FDA Citizen Petition on behalf of the group asking the

FDA to investigate laxatives containing Polyethylene Glycol 3350 (PEG 3350)

being prescribed to children.

> >

> >

> > The support group's co-founder, Jeanie Ward, has filed two FDA petitions

over the last 10 years and has seen an FDA Drug Safety Oversight Board convened

to discuss potential dangers to children without issuing warnings to doctors or

parents,http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTob\

acco/CDER/ucm171059.htm.

> >

> >

> > The number of adverse events related (in any way) to Polyethylene Glycol

3350 filed with the FDA has risen from 7 in 2001 to 2,257 in 2012. Adverse

events reported include kidney, digestive, and neurological events, including

tics, extreme behaviors, aggression, violence, and death.

> >

> >

> > Jeanie Ward started collecting adverse events and studies on PEG 3350 when

she noticed changes in her daughter while taking a best-selling PEG laxative,

Miralax. Doctors told her there was no connection. " I started doing my own

research and ordering adverse events reports from the FDA, as often as every 6

months – and the numbers started soaring. After hundreds of adverse events,

FDA's response was " there is insufficient evidence to require an amendment of

the product label at this time. "

> >

> >

> > Today the parent support group is host more than 1,600 members, mostly

parents looking for information on the laxatives and guidance on natural

protocols for treating their children's constipation. Polyethylene Glycol

laxatives are not approved by the FDA for use in children, but are being

prescribed off-label to children as young as 2 months old.

> >

> >

> > Polyethylene glycol is a petroleum based product and a relative of ethylene

glycol, the key ingredient in antifreeze. Although some medical professionals

deny a connection, parents are reporting symptoms similar to those seen with

ethylene glycol poisoning.

> >

> >

> > For more information on the petition contact Carol Chittenden, Empire State

Consumer Project at cachitter@...

> >

> > To reach Jeanie Ward, contact http://health.groups.yahoo.com/group/miralax/.

> >

> >

> >

> >

> >

> >

> >

> >

> >

> >

> >

>

>

>

>

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>

> Carol Chittenden

>

>

> Begin forwarded message:

>

> > From: CAChitter@...

> > Date: May 16, 2012 9:46:11 AM EDT

> > To: miralax

> > Subject: Petition is sent! Please circulate freely

> >

>

> > FOR IMMEDIATE RELEASE:

> >

> > Polyethylene Glycol Laxatives May Prove Harmful to Children

> >

> >

> > Rochester, New York, May 15, 2012 - After an eight month review of research

collected by a parent support

group,http://health.groups.yahoo.com/group/miralax/, Empire State Consumer

Project has submitted an FDA Citizen Petition on behalf of the group asking the

FDA to investigate laxatives containing Polyethylene Glycol 3350 (PEG 3350)

being prescribed to children.

> >

> > The support group's co-founder, Jeanie Ward, has filed two FDA petitions

over the last 10 years and has seen an FDA Drug Safety Oversight Board convened

to discuss potential dangers to children without issuing warnings to doctors or

parents,http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTob\

acco/CDER/ucm171059.htm.

> >

> > The number of adverse events related (in any way) to Polyethylene Glycol

3350 filed with the FDA has risen from 7 in 2001 to 2,257 in 2012. Adverse

events reported include kidney, digestive, and neurological events, including

tics, extreme behaviors, aggression, violence, and death.

> >

> > Jeanie Ward started collecting adverse events and studies on PEG 3350 when

she noticed changes in her daughter while taking a best-selling PEG laxative,

Miralax. Doctors told her there was no connection. " I started doing my own

research and ordering adverse events reports from the FDA, as often as every 6

months – and the numbers started soaring. After hundreds of adverse events,

FDA's response was " there is insufficient evidence to require an amendment of

the product label at this time. "

> >

> > Today the parent support group is host more than 1,600 members, mostly

parents looking for information on the laxatives and guidance on natural

protocols for treating their children's constipation. Polyethylene Glycol

laxatives are not approved by the FDA for use in children, but are being

prescribed off-label to children as young as 2 months old.

> >

> > Polyethylene glycol is a petroleum based product and a relative of ethylene

glycol, the key ingredient in antifreeze. Although some medical professionals

deny a connection, parents are reporting symptoms similar to those seen with

ethylene glycol poisoning.

> >

> > For more information on the petition contact Carol Chittenden, Empire State

Consumer Project at cachitter@...

> > To reach Jeanie Ward, contact http://health.groups.yahoo.com/group/miralax/.

> >

> >

> >

> >

> >

> >

> >

> >

> >

> >

> >

>

[Guest guest]

You did it. You never gave up. Jeannie I am so proud of you!!!!!Sent from my iPhone

Awesome work!!!

>

> > FOR IMMEDIATE RELEASE:

> >

> >

> > Polyethylene Glycol Laxatives May Prove Harmful to Children

> >

> >

> >

> > Rochester, New York, May 15, 2012 - After an eight month review of research collected by a parent support group,http://health.groups.yahoo.com/group/miralax/, Empire State Consumer Project has submitted an FDA Citizen Petition on behalf of the group asking the FDA to investigate laxatives containing Polyethylene Glycol 3350 (PEG 3350) being prescribed to children.

> >

> >

> > The support group's co-founder, Jeanie Ward, has filed two FDA petitions over the last 10 years and has seen an FDA Drug Safety Oversight Board convened to discuss potential dangers to children without issuing warnings to doctors or parents,http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm171059.htm.

> >

> >

> > The number of adverse events related (in any way) to Polyethylene Glycol 3350 filed with the FDA has risen from 7 in 2001 to 2,257 in 2012. Adverse events reported include kidney, digestive, and neurological events, including tics, extreme behaviors, aggression, violence, and death.

> >

> >

> > Jeanie Ward started collecting adverse events and studies on PEG 3350 when she noticed changes in her daughter while taking a best-selling PEG laxative, Miralax. Doctors told her there was no connection. "I started doing my own research and ordering adverse events reports from the FDA, as often as every 6 months – and the numbers started soaring. After hundreds of adverse events, FDA's response was "there is insufficient evidence to require an amendment of the product label at this time."

> >

> >

> > Today the parent support group is host more than 1,600 members, mostly parents looking for information on the laxatives and guidance on natural protocols for treating their children's constipation. Polyethylene Glycol laxatives are not approved by the FDA for use in children, but are being prescribed off-label to children as young as 2 months old.

> >

> >

> > Polyethylene glycol is a petroleum based product and a relative of ethylene glycol, the key ingredient in antifreeze. Although some medical professionals deny a connection, parents are reporting symptoms similar to those seen with ethylene glycol poisoning.

> >

> >

> > For more information on the petition contact Carol Chittenden, Empire State Consumer Project at cachitter@...

> >

> > To reach Jeanie Ward, contact http://health.groups.yahoo.com/group/miralax/.

> >

> >

> >

> >

> >

> >

> >

> >

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> >

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> Carol Chittenden

>

>

> Begin forwarded message:

>

> > From: CAChitter@...

> > Date: May 16, 2012 9:46:11 AM EDT

> > To: miralax

> > Subject: Petition is sent! Please circulate freely

> >

>

> > FOR IMMEDIATE RELEASE:

> >

> > Polyethylene Glycol Laxatives May Prove Harmful to Children

> >

> >

> > Rochester, New York, May 15, 2012 - After an eight month review of research collected by a parent support group,http://health.groups.yahoo.com/group/miralax/, Empire State Consumer Project has submitted an FDA Citizen Petition on behalf of the group asking the FDA to investigate laxatives containing Polyethylene Glycol 3350 (PEG 3350) being prescribed to children.

> >

> > The support group's co-founder, Jeanie Ward, has filed two FDA petitions over the last 10 years and has seen an FDA Drug Safety Oversight Board convened to discuss potential dangers to children without issuing warnings to doctors or parents,http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm171059.htm.

> >

> > The number of adverse events related (in any way) to Polyethylene Glycol 3350 filed with the FDA has risen from 7 in 2001 to 2,257 in 2012. Adverse events reported include kidney, digestive, and neurological events, including tics, extreme behaviors, aggression, violence, and death.

> >

> > Jeanie Ward started collecting adverse events and studies on PEG 3350 when she noticed changes in her daughter while taking a best-selling PEG laxative, Miralax. Doctors told her there was no connection. "I started doing my own research and ordering adverse events reports from the FDA, as often as every 6 months – and the numbers started soaring. After hundreds of adverse events, FDA's response was "there is insufficient evidence to require an amendment of the product label at this time."

> >

> > Today the parent support group is host more than 1,600 members, mostly parents looking for information on the laxatives and guidance on natural protocols for treating their children's constipation. Polyethylene Glycol laxatives are not approved by the FDA for use in children, but are being prescribed off-label to children as young as 2 months old.

> >

> > Polyethylene glycol is a petroleum based product and a relative of ethylene glycol, the key ingredient in antifreeze. Although some medical professionals deny a connection, parents are reporting symptoms similar to those seen with ethylene glycol poisoning.

> >

> > For more information on the petition contact Carol Chittenden, Empire State Consumer Project at cachitter@...

> > To reach Jeanie Ward, contact http://health.groups.yahoo.com/group/miralax/.

> >

> >

> >

> >

> >

> >

> >

> >

> >

> >

> >

>

[Guest guest]

Couldn't have done it without ALL of you! Thanks Deanna...............To: "miralax " <miralax >Cc: "miralax " <miralax >Sent: Mon, May 21, 2012 7:48:46 PMSubject: Re:

Re: Fwd: FDA petition on peg 3350

You did it. You never gave up. Jeannie I am so proud of you!!!!!Sent from my iPhone

Awesome work!!!

>

> > FOR IMMEDIATE RELEASE:

> >

> >

> > Polyethylene Glycol Laxatives May Prove Harmful to Children

> >

> >

> >

> > Rochester, New York, May 15, 2012 - After an eight month review of research collected by a parent support group,http://health.groups.yahoo.com/group/miralax/, Empire State Consumer Project has submitted an FDA Citizen Petition on behalf of the group asking the FDA to investigate laxatives containing Polyethylene Glycol 3350 (PEG 3350) being prescribed to children.

> >

> >

> > The support group's co-founder, Jeanie Ward, has filed two FDA petitions over the last 10 years and has seen an FDA Drug Safety Oversight Board convened to discuss potential dangers to children without issuing warnings to doctors or parents,http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm171059.htm.

> >

> >

> > The number of adverse events related (in any way) to Polyethylene Glycol 3350 filed with the FDA has risen from 7 in 2001 to 2,257 in 2012. Adverse events reported include kidney, digestive, and neurological events, including tics, extreme behaviors, aggression, violence, and death.

> >

> >

> > Jeanie Ward started collecting adverse events and studies on PEG 3350 when she noticed changes in her daughter while taking a best-selling PEG laxative, Miralax. Doctors told her there was no connection. "I started doing my own research and ordering adverse events reports from the FDA, as often as every 6 months – and the numbers started soaring. After hundreds of adverse events, FDA's response was "there is insufficient evidence to require an amendment of the product label at this time."

> >

> >

> > Today the parent support group is host more than 1,600 members, mostly parents looking for information on the laxatives and guidance on natural protocols for treating their children's constipation. Polyethylene Glycol laxatives are not approved by the FDA for use in children, but are being prescribed off-label to children as young as 2 months old.

> >

> >

> > Polyethylene glycol is a petroleum based product and a relative of ethylene glycol, the key ingredient in antifreeze. Although some medical professionals deny a connection, parents are reporting symptoms similar to those seen with ethylene glycol poisoning.

> >

> >

> > For more information on the petition contact Carol Chittenden, Empire State Consumer Project at cachitter@...

> >

> > To reach Jeanie Ward, contact http://health.groups.yahoo.com/group/miralax/.

> >

> >

> >

> >

> >

> >

> >

> >

> >

> >

> >

>

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>

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>

> Carol Chittenden

>

>

> Begin forwarded message:

>

> > From: CAChitter@...

> > Date: May 16, 2012 9:46:11 AM EDT

> > To: miralax

> > Subject: Petition is sent! Please circulate freely

> >

>

> > FOR IMMEDIATE RELEASE:

> >

> > Polyethylene Glycol Laxatives May Prove Harmful to Children

> >

> >

> > Rochester, New York, May 15, 2012 - After an eight month review of research collected by a parent support group,http://health.groups.yahoo.com/group/miralax/, Empire State Consumer Project has submitted an FDA Citizen Petition on behalf of the group asking the FDA to investigate laxatives containing Polyethylene Glycol 3350 (PEG 3350) being prescribed to children.

> >

> > The support group's co-founder, Jeanie Ward, has filed two FDA petitions over the last 10 years and has seen an FDA Drug Safety Oversight Board convened to discuss potential dangers to children without issuing warnings to doctors or parents,http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm171059.htm.

> >

> > The number of adverse events related (in any way) to Polyethylene Glycol 3350 filed with the FDA has risen from 7 in 2001 to 2,257 in 2012. Adverse events reported include kidney, digestive, and neurological events, including tics, extreme behaviors, aggression, violence, and death.

> >

> > Jeanie Ward started collecting adverse events and studies on PEG 3350 when she noticed changes in her daughter while taking a best-selling PEG laxative, Miralax. Doctors told her there was no connection. "I started doing my own research and ordering adverse events reports from the FDA, as often as every 6 months – and the numbers started soaring. After hundreds of adverse events, FDA's response was "there is insufficient evidence to require an amendment of the product label at this time."

> >

> > Today the parent support group is host more than 1,600 members, mostly parents looking for information on the laxatives and guidance on natural protocols for treating their children's constipation. Polyethylene Glycol laxatives are not approved by the FDA for use in children, but are being prescribed off-label to children as young as 2 months old.

> >

> > Polyethylene glycol is a petroleum based product and a relative of ethylene glycol, the key ingredient in antifreeze. Although some medical professionals deny a connection, parents are reporting symptoms similar to those seen with ethylene glycol poisoning.

> >

> > For more information on the petition contact Carol Chittenden, Empire State Consumer Project at cachitter@...

> > To reach Jeanie Ward, contact http://health.groups.yahoo.com/group/miralax/.

> >

> >

> >

> >

> >

> >

> >

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>

[Guest guest]

Thanks LeeAnn, coming from the smartest woman on here, that makes me feel good! To: miralax Sent: Mon, May 21, 2012 6:45:45 PMSubject: Re: Fwd: FDA petition on peg 3350

Awesome work!!!

>

> > FOR IMMEDIATE RELEASE:

> >

> >

> > Polyethylene Glycol Laxatives May Prove Harmful to Children

> >

> >

> >

> > Rochester, New York, May 15, 2012 - After an eight month review of research collected by a parent support group,http://health.groups.yahoo.com/group/miralax/, Empire State Consumer Project has submitted an FDA Citizen Petition on behalf of the group asking the FDA to investigate laxatives containing Polyethylene Glycol 3350 (PEG 3350) being prescribed to children.

> >

> >

> > The support group's co-founder, Jeanie Ward, has filed two FDA petitions over the last 10 years and has seen an FDA Drug Safety Oversight Board convened to discuss potential dangers to children without issuing warnings to doctors or parents,http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm171059.htm.

> >

> >

> > The number of adverse events related (in any way) to Polyethylene Glycol 3350 filed with the FDA has risen from 7 in 2001 to 2,257 in 2012. Adverse events reported include kidney, digestive, and neurological events, including tics, extreme behaviors, aggression, violence, and death.

> >

> >

> > Jeanie Ward started collecting adverse events and studies on PEG 3350 when she noticed changes in her daughter while taking a best-selling PEG laxative, Miralax. Doctors told her there was no connection. "I started doing my own research and ordering adverse events reports from the FDA, as often as every 6 months – and the numbers started soaring. After hundreds of adverse events, FDA's response was "there is insufficient evidence to require an amendment of the product label at this time."

> >

> >

> > Today the parent support group is host more than 1,600 members, mostly parents looking for information on the laxatives and guidance on natural protocols for treating their children's constipation. Polyethylene Glycol laxatives are not approved by the FDA for use in children, but are being prescribed off-label to children as young as 2 months old.

> >

> >

> > Polyethylene glycol is a petroleum based product and a relative of ethylene glycol, the key ingredient in antifreeze. Although some medical professionals deny a connection, parents are reporting symptoms similar to those seen with ethylene glycol poisoning.

> >

> >

> > For more information on the petition contact Carol Chittenden, Empire State Consumer Project at cachitter@...

> >

> > To reach Jeanie Ward, contact http://health.groups.yahoo.com/group/miralax/.

> >

> >

> >

> >

> >

> >

> >

> >

> >

> >

> >

>

>

>

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>

>

> Carol Chittenden

>

>

> Begin forwarded message:

>

> > From: CAChitter@...

> > Date: May 16, 2012 9:46:11 AM EDT

> > To: miralax

> > Subject: Petition is sent! Please circulate freely

> >

>

> > FOR IMMEDIATE RELEASE:

> >

> > Polyethylene Glycol Laxatives May Prove Harmful to Children

> >

> >

> > Rochester, New York, May 15, 2012 - After an eight month review of research collected by a parent support group,http://health.groups.yahoo.com/group/miralax/, Empire State Consumer Project has submitted an FDA Citizen Petition on behalf of the group asking the FDA to investigate laxatives containing Polyethylene Glycol 3350 (PEG 3350) being prescribed to children.

> >

> > The support group's co-founder, Jeanie Ward, has filed two FDA petitions over the last 10 years and has seen an FDA Drug Safety Oversight Board convened to discuss potential dangers to children without issuing warnings to doctors or parents,http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm171059.htm.

> >

> > The number of adverse events related (in any way) to Polyethylene Glycol 3350 filed with the FDA has risen from 7 in 2001 to 2,257 in 2012. Adverse events reported include kidney, digestive, and neurological events, including tics, extreme behaviors, aggression, violence, and death.

> >

> > Jeanie Ward started collecting adverse events and studies on PEG 3350 when she noticed changes in her daughter while taking a best-selling PEG laxative, Miralax. Doctors told her there was no connection. "I started doing my own research and ordering adverse events reports from the FDA, as often as every 6 months – and the numbers started soaring. After hundreds of adverse events, FDA's response was "there is insufficient evidence to require an amendment of the product label at this time."

> >

> > Today the parent support group is host more than 1,600 members, mostly parents looking for information on the laxatives and guidance on natural protocols for treating their children's constipation. Polyethylene Glycol laxatives are not approved by the FDA for use in children, but are being prescribed off-label to children as young as 2 months old.

> >

> > Polyethylene glycol is a petroleum based product and a relative of ethylene glycol, the key ingredient in antifreeze. Although some medical professionals deny a connection, parents are reporting symptoms similar to those seen with ethylene glycol poisoning.

> >

> > For more information on the petition contact Carol Chittenden, Empire State Consumer Project at cachitter@...

> > To reach Jeanie Ward, contact http://health.groups.yahoo.com/group/miralax/.

> >

> >

> >

> >

> >

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