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# Caregivers Missing Safety Signals on Celgene’s Idhifa
- URL: https://www.fdaweb.com/caregivers-missing-safety-signals-on-celgenes-idhifa/
- Published: 2018-11-29T12:00:00.000Z
- Updated: 2026-09-15T00:47:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142925

FDA is warning that signs and symptoms of a life-threatening side effect called “differentiation syndrome” are not being identified in patients receiving Celgene’s acute myeloid leukemia drug Idhifa (enasidenib). A [safety alert](https://www.fda.gov/Drugs/DrugSafety/ucm626923.htm?ref=fdaweb.com) notes that the drug’s [prescribing information](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209606&ref=fdaweb.com) and [patient Medication Guide](https://www.accessdata.fda.gov/drugsatfda%5Fdocs/label/2017/209606s000lbl.pdf?ref=fdaweb.com#page=16) already contain a warning about the syndrome. Differentiation syndrome has occurred as early as 10 days and up to five months after starting therapy, the agency says. “If patients experience unexplained respiratory distress or other symptoms, consider a diagnosis of differentiation syndrome and treat promptly with oral or intravenous corticosteroids,” it says.