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No proof peg 3350 safe for children, State of Oregon study

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The FDA withdrew tegaserod maleate from the market after reporting that in clinical studies 0.1% (n = 13) of patients treated with tegaserod experienced serious and life-threatening cardiovascular adverse events, compared with 0.01% (n = 1) of patients on placebo. The FDA has agreed to allow access to the medication through a special program when the benefits outweigh the risks of series adverse events or for patients with no other treatment options. The FDA also indicated that it will consider limited re-introduction of the medication at a later date. To: miralax Sent: Tue, May 22, 2012 7:56:42 AMSubject: No proof peg 3350 safe for children, State of Oregon study

This review done in 2008 by the State of Oregon did not find any research using placebo studies not conducted by industry to show peg 3350 to be safe for children...

http://www.oregon.gov/OHA/pharmacy/therapeutics/docs/hrc-2008-12-constipation.pdf?ga=t

Carol

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