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Safety Alert: Mycophenolate

Revised pregnancy rating

What does this mean?

This alert involves new information regarding the safety of Mycophenolate.

The FDA has issued a warning today that Mycophenolate may increase the risk of developing fetal malformations or pregnancy loss in the first trimester. This advice was issued after the FDA received reports of pregnancy loss and congenital malformations that may have been linked to Mycophenolate use.

The pregnancy category for this drug has been changed from a C (risk of fetal harm cannot be ruled out) to a D (positive evidence of fetal risk).

For more information, please visit:

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm072438.htm

This alert involves new information regarding the safety of Mycophenolate.

The FDA has issued a warning today that Mycophenolate may increase the risk of developing fetal malformations or pregnancy loss in the first trimester. This advice was issued after the FDA received reports of pregnancy loss and congenital malformations that may have been linked to Mycophenolate use.

The pregnancy category for this drug has been changed from a C (risk of fetal harm cannot be ruled out) to a D (positive evidence of fetal risk).

For more information, please visit:

more information here

Source: FDA
Publication Date: 2007-11-27
Last Updated: 2009-12-06

Visit the medication page for the following drugs:
Mycophenolate medication page