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U.S. Department of Health and Human Services

Safety

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Hydrea (hydroxyurea capsules)

Hydrea (hydroxyurea capsules)
Droxia (hydroxyurea capsules)

Audience: Pharmacists and Oncological healthcare professionals
[Posted 01/26/2006] Bristol-Myers Squibb notified healthcare professionals about revisions to the WARNINGS and ADVERSE REACTIONS sections of the prescribing information 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. The PRECAUTIONS and DOSING AND ADMINISTRATION sections have been revised to provide updated information on the safe handling of these products.

The proposed changes are highlighted in the following "Dear Healthcare Provider" letters issued January 2006 by Bristol-Myers Squibb; specific wording of these additions and revisions to the labeling is pending FDA review and approval.

[January 20, 2006 – Hydrea letter – Bristol-Myers Squibb]
[January 20, 2006 – Droxia letter – Bristol-Myers Squibb]