FDA: symptoms of serious condition not being recognized in Idhifa users

The U.S. Food and Drug Administration announced that it is warning that signs and symptoms of a life-threatening side effect called differentiation syndrome are not being recognized in patients receiving the acute myeloid leukemia medicine Idhifa. “The Idhifa prescribing information and patient Medication Guide already contain a warning about differentiation syndrome. However, we have become aware of cases of differentiation syndrome not being recognized and patients not receiving the necessary treatment. As a result, we are alerting health care professionals and patients about the need for early recognition and aggressive management of differentiation syndrome to lessen the likelihood of serious illness and death. We are continuing to monitor this safety concern,” the FDA stated in a safety announcement posted to its website. Celgene (CELG) and Agios (AGIO) are partners on Idhifa.
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