UPDATE 1-FDA reviewing Roche, Novartis drug risk plans
06 May 2009 - Reuters
* CellCept, Myfortic used in transplant patients
* FDA ordered drugmakers to submit risk plan in 2008
* Pregnancy registry planned to ensure safe use
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WASHINGTON, May 6 (Reuters) - The U.S. Food and Drug Administration said Wednesday it is reviewing risk management plans by Novartis AG NOVN.VX and Roche Holding AG ROG.VX for transplant drugs linked to birth defects.
The drugs are Novartis' Myfortic and Roche's CellCept, both of which are used to help prevent organ rejection in transplant patients.
CellCept was approved in 1995 and is used with patients who receive a new kidney, heart or liver. Myfortic was approved in 2004 and is used in kidney transplant patients.
The FDA said it is reviewing a risk management plan that it ordered last September for both drugs after the agency became aware of new safety data. The plans must ensure that the drug benefits outweigh the risk of birth defects, the FDA said.
The risk management plans will include a pregnancy registry, physician training and certification and other components to ensure safe use of the drugs, the FDA said.
The FDA posted its announcement about the review on the web at: https://www.fda.gov/cder/drug/infopage/mycophenolate/REMS.htm (Reporting by Julie Vorman; Editing by Gerald E. McCormick)