The Food and Drug Administration is reviewing proposed label changes for Hydrea and Droxia (hydroxyurea capsules) that warn of cutaneous vasculitic toxicities.
Bristol-Myers Squibb has notified health care professionals about revisions to the Warnings and Adverse Reactions sections of the prescribing information to include information about vasculitic ulcerations and gangrene that have occurred in patients with myeloproliferative disorders during therapy with hydroxyurea. The vasculitic toxicities were reported most often in patients who had received, or were currently receiving, interferon therapy.
Significant tumor response to Hydrea has been demonstrated in melanoma, resistant chronic myelocytic leukemia; and recurrent, metastatic, or inoperable carcinoma of the ovary. Used concomitantly with irradiation therapy, the drug is intended for use in the local control of primary squamous cell (epidermoid) carcinomas of the head and neck, excluding the lip.
Droxia is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult patients with sickle cell anemia with recurrent moderate to severe painful crises. Hydroxyurea should be discontinued in these patients if cutaneous vasculitic ulcerations develop. Changes have also been added to the Precautions section of prescribing information to warn physicians that elderly patients may be more sensitive to the effects of Hydrea.
For more information, or to report serious adverse events suspected to be associated with Hydrea or Droxia, contact the company by calling 800-321-1335 or contact the FDA's MedWatch Reporting System by calling 800-332-1088.