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09/04/2009 - Correction of Alert issued on 09/03/2009. The manufacturer of Myfortic was misidentified in the earlier notice. MedWatch apologizes for the error and has provided the correct information below.
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Myfortic (mycophenolic acid)
Audience: Renal, cardiac, and hepatic transplantation healthcare professionals
Novartis and FDA notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with Myfortic. The WARNINGS and ADVERSE REACTIONS sections of the Myfortic Prescribing Information have been revised to reflect this new safety information.
PRCA is a type of anemia in which there is a selective reduction of red blood cell precursors on bone marrow examination. Patients with PRCA may present with fatigue, lethargy, and/or abnormal paleness of the skin (pallor). In some cases, PRCA was found to be reversible with dose reduction or cessation of Myfortic therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk.
Read the complete MedWatch Safety summmary (corrected) at:
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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
