Re: FDA Petition / Press Release [1 Attachment]

[Guest guest]

Ok came thru right. Spacing is messed up on phone copyCarol Chittenden

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 to 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 FDA petition contact Carol Chittenden, Empire State Consumer

Project at cachitter@....

To reach

Jeanie Ward or obtain copies of parent testimonies and adverse event documents,

contact dreamjeanie@....