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Additional CommentaryAdditional Commentary:How common is the occurrence of hydroxyurea-related leg ulcers?
I don’t know the exact rate, but hydroxyurea-related leg ulcers are not common. I suspect the rate is less than 10%. I’ve had patients with ulcers, including mouth ulcers. The issue usually is a matter of correct dosing. Generally, I would only restart treatment with hydroxyurea if I felt that I didn’t have any other treatment options. If they had ulcers, then I really would try to find another agent, such as busulfan or pegylated interferon.
Hydroxyurea can cause leg ulcers. Usually it’s a contraindication to pursue hydroxyurea further. Therefore I try to not continue administering it.
I have found that leg ulcers occur more commonly in people who have other predispositions to peripheral vascular disease. I see it occur most in people who were smokers, have vascular disease or are older. I don’t tend to see them occur in a younger person who has been started on hydroxyurea. It's conceivable that they could develop, but I see leg ulcers occur usually in the setting of other risks factors of peripheral vascular disease being present. If leg ulcers do occur in a patient while they are on hydroxyurea therapy, the patient should probably not be rechallenged.
These leg ulcers are uncommon, but they do happen and are clearly associated with the drug. It’s a less than 5% rate of complication, but it does not get better. You can perform a skin graft. You can do hyperbaric oxygen. However, until you stop the hydroxyurea, it’s not going to get better. Also, the ulcers recur if you try to restart the hydroxyurea. The underlying mechanism is not well understood, but in my mind, leg ulcers are a clear indication for stopping the hydroxyurea if they develop.
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