Fwd: revised, sorry

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dreamjeanie@... wrote: To: miralax (miralax )From: dreamjeanie@...Date: Mon, 25 Feb 2008 13:22:32 +0000Subject: revised, sorry This is my letter to the FDA, I would appreciate any comments or anything else you would like me to include or exclude........ February 25, 2008 Jeanie Ward Re: Petitioning the FDA for the "Safety and Effectiveness of Polyethylene Glycol 3350 for pediatric

use" Dear Sirs, I am re-petitioning the FDA in regards to the safety and effectiveness of Polyethylene Glycol 3350 in pediatric use, there seems to be growing numbers of adverse side affects since they started administering, off label use of this medication to children. I petitioned the FDA in 2001 and the FDA replied that, "The FDA has been unable to reach a decision on my petition because it raises issues that require additional review and analysis by the Agency" We have created a website pertaining to this, titled, miralax There are about 5000 posts, and 450 members, of parents concerned about the negative side affects that their children are experiencing. In 2000, I contacted MedWatch, and requested the (AERS) FOIA a Advers Reaction Reports, there were only 6 adverse reactions to Polyethylene Glycol 3350, since then, the numbers have climbed to over 600,

including death and there are probably many more since then. Without recognition of this issue, the children are receiving no merit as to what has happened to them, regarding the harm that this medication has caused. I am requesting that the FDA launch a thorough investigation. Sincerely, Jeanie Ward