for FDA letter

[Guest guest]

I'd like to add our story: Our son was 3 when he was put on Miralax at 1 capful per day for 10 days after 3 years of chronic constipation. This is the adult dosage. Ten days later, he was crying from pain, his stomach so bloated I wondered if his skin would be permanently stretched. Our GI specialist at Mayo in Rochester, MN, absolutely assured me he was fine and would have a bowel movement soon. Instead of having bowel movements, his stools began leaking out around his solid stool. The same GI diagnosed him with encopresis. He ordered one enema per day until a stool was produced. He was kept on the Miralax. When he was 7, I took him off this drug, cold turkey. In the 4 years in-between, he went from a sweet, happy, energetic little boy to a pale, tired, angry, fearful, paranoid, confused, crying child. We could not console him or comfort him no matter what we did. At 3 and a half, he was diagnosed with high-functioning Aspergers regardless of his normal development until then. When he went to school at 4 and a half, we had to have him on a bathroom plan because his stool was constantly leaking. He would often soil his pants several times per day. Still, his doctor said he had constipation and kept him on Miralax, even though it was obviously not working. For four years, he pooped his pants at school and did not have friends. Teachers asked him to be transferred from their rooms because the stool was soiling and smelling up the carpet in their classrooms. He could not interact socially with his peers and he was terrified of loud noises. It was awful. When he was 7, and the final straw, he became so violent and angry that he descriptively told his father and me how he planned to kill us because we asked him to hang up four shirts in his closet. It was then that I started researching Miralax, asking questions to doctors, homeopaths, nutritionists and naturopaths. He was given a Schedule III anti-psychotic drug to alleviate his violence. I took him off Miralax and the Schedule III drug. Slowly, slowly, we have gotten our son back. Thanks to a variety of more holistic interventions and a foreign medical intervention, our son is now about as "normal" as he's going to be. He is not the same little boy he probably was heading toward before Miralax, but he is back better than we thought we could do. This is only a SMALL part of his life. There's a lot more to our story, but in my opinion, Miralax took my child from me. I sincerely hope no other family has to go through this because of chronic constipation. There are other and better methods than Miralax. Sincerely,Tracie and Carl HappelOnalaska, WI

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