Alerts
Immunosuppressant Drugs – Labeling Changes Warning of Increased Risk of Opportunistic Infections
July 15, 2009
The FDA is requiring manufacturers to update the labeling of several immunosuppressant medications used to prevent organ transplant rejection to reflect the increased risk for opportunistic infections. This labeling change follows an Adverse Event Reporting System analysis showing an association between immunosuppressant drugs and BK virus-associated nephropathy, which is primarily seen in renal transplant patients. Products requiring updated labeling include cyclosporine (Neoral®, Sandiummune® and generics), mycophenolic acid (Myfotic®) mycophenolate mofetil (Cellcept® and generics) and sirolimus (Rapamune).
Similar findings were previously reported for tacrolimus (Prograf®). The prescribing information of tacrolimus has already been updated to reflect these findings. Activation of this normally latent virus can lead to renal allograft loss. Careful monitoring and early intervention is critical to prevent graft loss in patients at risk.
- MedWatch Alert
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171828.htm - Information for Healthcare Providers
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm171654.htm
July 15, 2009; University of Utah, Drug Information Service.
Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
