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Author Topic: FDA Issues Alert On Wyeth Kidney Transplant Drug  (Read 1285 times)
okarol
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« on: June 15, 2009, 09:23:04 PM »

JUNE 11, 2009, 2:57 P.M. ET

FDA Issues Alert On Wyeth Kidney Transplant Drug

By Jennifer Corbett Dooren

Of DOW JONES NEWSWIRES

 

WASHINGTON (Dow Jones)--The Food and Drug Administration sent health-care professionals an alert Thursday about a Wyeth (WYE) kidney-transplant drug that discussed a possible increased risk of death.

The FDA said Wyeth submitted clinical trial data involving Rapamune "that suggested that there may be increased mortality in patients converted from calcineurin inhibitor therapy to [Rapamune]." The study involved use of the drug in liver-transplant patients.

The drug is only approved for use in kidney-transplant patients. The agency said "the safety and efficacy of this drug in liver or lung transplant patients have not been established."

The FDA said it is determining whether a labeling change is needed. Rapamune already carries the agency's toughest boxed-warning, which includes langauge cautioning against use of the drug in liver patients.

 

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com
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Admin for IHateDialysis 2008 - 2014, retired.
Jenna is our daughter, bad bladder damaged her kidneys.
Was on in-center hemodialysis 2003-2007.
7 yr transplant lost due to rejection.
She did PD Sept. 2013 - July 2017
Found a swap living donor using social media, friends, family.
New kidney in a paired donation swap July 26, 2017.
Her story ---> https://www.facebook.com/WantedKidneyDonor
Please watch her video: http://youtu.be/D9ZuVJ_s80Y
Living Donors Rock! http://www.livingdonorsonline.org -
News video: http://www.youtube.com/watch?v=J-7KvgQDWpU
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