Hydrea, Droxia Linked to Cutaneous Vasculitic Toxicities

Yael Waknine


January 26, 2006

Jan. 26, 2006 -- The US Food and Drug Administration (FDA) and Bristol-Myers Squibb have notified healthcare professionals via letter regarding revisions to the safety labeling for hydroxyurea capsules ( Hydrea and Droxia), to advise of the risk for cutaneous vasculitic toxicities associated with its use in patients with myeloproliferative disorders.

These toxicities have included vasculitic ulcerations and gangrene, occurring most often in patients receiving or having received interferon therapy, according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program.

Because of the risk for severe outcomes in patients with myeloproliferative disease, hydroxyurea should be discontinued if cutaneous ulcerations develop. Alternative cytoreductive agents may be initiated as indicated.

The FDA also warned that elderly patients are more likely to have decreased kidney function and may therefore be at increased risk for toxicity from the renally excreted drug. Dose reductions may be required, and consideration should be given to monitoring renal function in these patients.

In addition, the FDA advised use of impervious gloves to minimize the risk of dermal exposure when handling bottles of hydroxyurea capsules in clinical settings, pharmacies, storerooms, and home healthcare settings during unpacking/inspection, transport within a facility, and dose preparation/administration.

Patients should be advised to wear disposable gloves when handling hydroxyurea or bottles containing the capsules, and to wash their hands before and after contact with the bottle and capsules. Powder spilled from the capsules should be wiped up immediately with a damp disposable towel and discarded in a closed plastic container such as a plastic bag.

Hydroxyurea 500-mg capsules ( Hydrea) are indicated for use in combination with irradiation therapy for local control of primary squamous cell carcinoma of the head and neck, excluding the lip. Significant tumor response to hydroxyurea has been demonstrated in melanoma, resistant chronic myelocytic leukemia, and recurrent, metastatic, or inoperable cancer of the ovary.

Hydroxyurea 200-, 300-, and 400-mg capsules ( Droxia) are indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult patients with sickle cell anemia and recurrent moderate to severe painful crises (generally at least 3 in the preceding 12 months).

Healthcare professionals are encouraged to report adverse events related to use of hydroxyurea capsules to the company at 1-800-321-1335. Direct contact with a representative is available at this number, in addition to an automated faxback system that can be used to order an adverse event reporting form (document code 2000).

Alternatively, this information may be reported to the FDA's MedWatch reporting system by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch , or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD