LABELING CHANGES ANNOUNCED FOR DROXIA AND HYDREA
Bristol-Myers Squibb (BMS) has notified healthcare professionals about revisions to the prescribing information on two of its oncology drugs: Hydrea (hydroxyurea) and Droxia (hydroxyurea).
The revisions describe cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, in patients with myeloproliferative disorders during therapy with hydroxyurea, most often reported in patients with a history of or currently receiving interferon therapy, BMS said in recent letters to healthcare professionals, which were posted recently on the FDA's MedWatch website.
The following information was added to the warnings section of both Hydrea and Droxia:
"Cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, have occurred in patients with myeloproliferative disorders during therapy with hydroxyurea. These vasculitic toxicities were reported most often in patients with a history of, or currently receiving, interferon therapy. Due to potentially severe clinical outcomes for the cutaneous vasculitic ulcers reported in patients with myeloproliferative disease, hydroxyurea should be discontinued if cutaneous vasculitic ulcerations develop and alternative cytoreductive agents should be initiated as indicated."
Specific wording of the additions and revisions to the labeling is pending FDA review and approval. The letters are available at: http://www.fda.gov/medwatch/safety/2006/HydreaDearDrLtr.pdf (http://www.fda.gov/medwatch/safety/2006/HydreaDearDrLtr.pdf) and http://www.fda.gov/medwatch/safety/2006/DroxiaDearDrLtr.pdf (http://www.fda.gov/medwatch/safety/2006/DroxiaDearDrLtr.pdf).