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Myfortic may cause anemia, FDA and Novartis say

9/8/2009

ROCKVILLE, Md. Patients taking a drug for organ transplants have reported experiencing a type of anemia, the Food and Drug Administration and the drug’s manufacturer have announced.

The FDA and Novartis announced last week that some patients taking Myfortic (mycophenolic acid) had reported cases of pure red cell aplasia. PRCA causes selective reduction of red blood cell precursors in the bone marrow, where the cells are formed. Symptoms include fatigue, lethargy and abnormal paleness of the skin, though some cases can be reversed by reducing dosage of the drug.

PRCA has also been reported in patients taking Roche’s CellCept (mycophenolate mofetil). The sections of both drugs’ labeling listing warnings and possible adverse side effects have been updated, the FDA said.

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