FDA issues Myfortic tablets safety alert

The U.S. Food and Drug Administration issued a safety alert for pregnant patients using the kidney transplant drug Myfortic delayed-release tablets.

The FDA said it has been determined the medication is associated with increased risks of pregnancy loss and congenital malformations. Officials said the pregnancy category for Myfortic has been changed to Category D -- positive evidence of fetal risk.

Myfortic is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids.

The FDA said a transplant patient planning a pregnancy shouldn't use Myfortic unless she cannot be successfully treated with other immunosuppressant drugs.

Myfortic is manufactured by Novartis Pharmaceuticals.

Copyright 2007 by United Press International

Citation: FDA issues Myfortic tablets safety alert (2007, November 28) retrieved 28 March 2024 from https://medicalxpress.com/news/2007-11-fda-issues-myfortic-tablets-safety.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.

Explore further

Study confirms safety of new flow-diverting stent in the treatment of brain aneurysms

 shares

Feedback to editors