Fw: ok to send this

[Guest guest]

Members, here is a rough outline excluding all the links and material provided. This has to go through many approvals before distributing so if anyone has any pertinent information to add, please do so as we've been working day and night to get this completed. Our estimated deadline is this week..............Thank you!Jeanie ----- Forwarded Message ----To: dreamjeanie@...Sent: Sun, January 1, 2012 6:24:04 PMSubject: ok to send this

Miralax Petition Outline 1. Introduction – History of Miralax Yahoo Group, PEG adverse events (over 2000), FDA Drug Oversight Board Meeting and findings, request for investigation. 2. FDA Drug Safety Oversight Board Meeting, 2009, Public Summary 3. History of Miralax 4. Intended Use – Adults, Occasional Constipation, Short Term Use 5. Off- Label Use – Children, Chronic Constipation, Long Term Use, Adverse Events Not Reported, Bowel Obstruction Not Ruled Out, Sound Medical Evidence Lacking. 6. Risk in Off-Label Prescribing – Study shows doctors don’t know uses 7. Adverse Events – Bowel, Urinary, Kidney, Blood, Skin, Neuropsychiatric, Suicide/Attempted, Death 8. Clinical Trials on Children 9. Children Are Not Small Adults – Risks to Children in Particular 10. Excretion / Permeability 11. Toxics – Ethylene Glycol, DiEthylene Glycol, 1.4 Dioxane, Aluminum, PEG is Plastic 12. Use of Miralax in Bowel Preparations – Off-Label Use for Pre-Colonoscopy and Dangers 13. Parents Need Answers – Protein Absorption, Bacteria in Gut, Aspiration, PEG Heat Absorption, Colon Hydrotherapy as Alternative 14. PEG 3350 Material Safety Data Sheet and warnings 15. Parent Statements 16. Adverse Event Reports