Re: List of attachments

[Guest guest]

I fixed any typos I found and added after my signature, but had a couple of questions...

parent statements on there 2ce - which is correct place?

is 29. a duplicate?

is 32 spelled right? Should it be Electrolyte?

There is one study with rats in the title that I don't recognize from the petition.

Thanks!

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