New warnings about Hydrea/Droxia (hydroxyurea)

January 30, 2006 - Bristol-Myers Squibb notified healthcare professionals about revisions to the WARNINGS and ADVERSE REACTIONS sections of the prescribing information for Hydrea and Droxia (hydroxyurea capsules) to 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.

This drug is known to be excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal.

To minimize the risk of dermal exposure, always wear impervious gloves when handling bottles containing hydroxyurea capsules. This includes all handling activities in clinical settings, pharmacies, storerooms, and home healthcare settings, including during unpacking and inspection, transport within a facility, and dose preparation and administration.

Questions or concerns regarding this important safety information can be directed to Bristol-Myers Squibb medical department at 1-800-321-1335. As always, pharmacies and members can also contact the RxAmerica customer service desk at 1-800-770-8014 if they have any questions about this new product warning.