FDA Drug Safety Communication for Idhifa

Published: 11/30/2018

  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) is warning that signs and symptoms of the life-threatening side effect, differentiation syndrome, are not being recognized in patients receiving the acute myeloid leukemia medicine Idhifa (enasidenib). The Idhifa prescribing information and patient Medication Guide already contain a warning about differentiation syndrome. However, the FDA has become aware of cases of differentiation syndrome not being recognized and patients not receiving the necessar

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