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MITOXANTRONE INJECTION

Posted Wednesday 30 July 2008 - 10:02 AM by John Sollazzo ( HIGH significance )

ATC Code

L01DB07

Warning

Check LVEF annually - recommended by FDA

Due to concerns of cardiotoxicity, the FDA has recommended since 2005 that LVEF be evaluated before administration of each dose. However, the agency "has received information from a post-marketing safety study that demonstrated there is poor adherence to these recommendations in clinical practice."

Evidence

Good

Reference

http://www.fda.gov/medwatch/safety/2008/safety0...

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