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EU: Doctors Told Not To Use Defitelio As A Prophylactic For VOD

 
• By Vibha Sharma

While Defitelio is not authorized in the EU for the prevention of veno-occlusive disease (VOD), the European Medicines Agency wants health professionals to be informed about the results of a recent study in which the drug showed no benefit in this indication.

liver
Defitelio is approved for treating hepatic VOD in patients undergoing stem cell transplant • Source: Shutterstock

Gentium SRL, a Jazz Pharmaceuticals company, will be writing to health care professionals in the EU advising them that its orphan drug Defitelio (defibrotide) should not be used to prevent liver veno-occlusive disease (VOD) in patients undergoing blood stem cell transplantation.

The company’s proposed direct health care professional communication (DHPC) to this effect was reviewed by the European Medicines Agency’s pharmacovigilance...

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