Warning for Blood Drug Hydroxyurea
Risk of Serious Skin Complications, Including Gangrene, Says Maker
Jan. 27, 2006 -- Drug company Bristol-Myers Squibb is alerting doctors about the risk of serious skin complications, including ulcers and gangrene, with its drug hydroxyurea.
Hydroxyurea is used to treat precancerous blood conditions called myeloproliferative disorders and may also be used to treat sickle cell disease. It's sold as Hydrea and Droxia.
Hydroxyurea's prescribing information will be updated to warn of the risk. The warning will advise doctors to stop using the drug in patients who experience those skin problems, switching those patients to other medicines.
The warning will also note that elderly patients may be more sensitive to hydroxyurea's effects and may need lower doses.
The skin reactions have mainly been reported in patients taking hydroxyurea who are also using the drug interferon or who have taken interferon in the past, states Bristol-Myers Squibb's letter to doctors. The letter is posted on the FDA's web site.
Specific wording of hydroxyurea's new warning is pending FDA review and approval, states an FDA news release.