Petitioning the FDA

[Guest guest]

Please remember that less is more upon writing a statement. If you want to write a lengthly letter, that's fine, but I don't want anyone to be overwhelmed with the holiday's just here and the thought of having to write a formal type letter / novel. Everyone I've ever spoke to regarding this issue seems to downplay what this medication has caused if:A) they were on other medicationsB) if they have other health issues like Autism, Tourettes, or any other disability. C) they have all kinds of issues, vaccines, allergies, heavy metals, etc. In my mind, if all the above are experiencing the same symptoms, young, old, & autistic, then we need to look at the one common denominator, the drug they all took as the culprit. Not to mention all the normal children that took this medication that started to exhibit autistic like behaviors. One doesn't need to write a novel. A simple statement, like my normal child took this medication and ______________ happened. People will listen if we work in numbers. Thank you for the internet which I like to refer to as thousand way calling! 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