Guest guest Posted March 17, 2012 Report Share Posted March 17, 2012 Here is the list of attachments that are included in the petition I just added. XV. Attachments 1. Parent Statements 2. Adverse Events 7 adverse reactions November 2000 54 adverse reactions April 2001 89 adverse reactions March 2002 161 adverse reactions October 2003 238 adverse reactions September 2004 447 adverse reactions January 2006 665 adverse reactions April 2007 869 adverse reactions March 2008 1,014 adverse reactions October 2009 1,966 adverse reactions June 2011 3. Jeanie Ward’s original petition from 2001 4. FDA Correspondence letter dated November, 14th, 2001 5. FDA Correspondence letter dated February 20th, 2002 6. Key to adverse reactions 7. Summary of adverse reactions numbers, starting with 7 in 2001 to 2,257 in 2012 (10 pages) 8. Summary of pertinent adverse reactions 9. Golytely Solution for Colonscopy Preparation article 10. Parents Statements 11. Food and Drug Oversight Board Meeting, June 18,2009 12. Fatal Disnatraemia Article Rapid Response Ayus 13. FOIA adverse reactions of Children and Adults / Individual Reports Deaths Rage / Anxiety Suicide Seizures Aspiration Hyponatraemia Kidney Failure Failure to Thrive Tics Accute Tubular Necrosis Stopped Breathing Burning Sensation 14. Label insert, Do not give to children 15. Urinary Excretion of Polyethylene Glycol 3350 article 16. Children’s dose MEDLINE 17. Neurologist’s statement on Miralax 18. Nexgen manufacturer’s letter Not to give to pediatrics 19. Potential Signals of Serious Risks 20. What is PEG Thermo Scientific 21. PEG compounds and their contaminants 22. MSDS 23. Polyethylene Glycols (PEG’s) 24. Department of health and Human Services NDA 20-698 25. Miralax Fact Sheet The Beauty of 4-in-1 Action 26. Comparison of Oral Sodium Phosphate to Polyethylene Glycol-based Solution 27. MiraLAX Drug Facts 28. Fatal dysnatraemia caused by elective colonoscopy BMJ 29. Last of lasting effictiveness of PEG 3350 laxative treatment of constipation 30. Miralax Powder for Oral Solution 31. Center For Drug Evaluation and Research Application # 21.551 32. Acute Renal Failure after Ingestion of Polyethylene Glycol Electrolytel lavage Solution for Bowel Prep 33. Miralax Drug Facts II 34. Polyethylene Glycol Chemistry Daily 35. Disparities: Study Finds Risk in Off-label prescribing 36. Program using Miralax ups constipation cures 37. Drug Lib.com Miralax / Description and Clinical Pharmacology 38. PEGylated proteins: Evaluation of their safety in the adsence of definitive metabolism studies 39. Increased intestinal permeability in patients with Chrohn’s disease and their relatives 40. Increased permeability assessed with polyethylene glycols in children with diarrhea due to rotovirus And common bacterial pathogens in developing community. 41. Polyethylene glycol, unique among laxitives, suppresses aberrant crypt foci, by elimination of cells 42. Lemon juice has protective activity in rat urolithiasis model 43. Metabolic Acidosis 44. Pediatric nephrology, Volume 20, Number 12- SpringerLink 45. Hypnonatremia in emergency medicine treatment & management 46. Miralax (Polyethylene Glycol 3350) – Side effects & Adverse reactions Reported to the FDA 47. Some Pharmaceutical clinical trial results are Buried, study shows 48. The efficiency side effects and the tolerance of polyethylene glycol 3350 as a bowel prep in children 49. The pathophysiology and treatment of hyyponatraemic encephalopathy: an update 50. Polyethylene Glycol 3350 Drug interactions 51. Chemical Encyclopedia 1,4-dioxane Quote Link to comment Share on other sites More sharing options...
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