Bristol-Myers Squibb issues warning about skin complications caused by hydroxyurea

March 7, 2006

New York -- Bristol-Myers Squibb is alerting doctors about the risk of serious skin complications, including ulcers and gangrene, associated with its drug hydroxyurea.

New York - Bristol-Myers Squibb is alerting doctors about the risk of serious skin complications, including ulcers and gangrene, associated with its drug hydroxyurea.

Hydroxyurea, which is sold as Hydrea and Droxia, is used in the treatment of precancerous blood conditions called myeloproliferative disorders and may also be used to treat sickle cell disease.

The company said 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 ulcers and gangrene and to switch those patients to other medicines. It will also note that elderly patients may be more sensitive to hydroxyurea’s effects and may need lower doses.

The skin reactions have been reported in patients taking hydroxyurea who are also taking interferon or who have taken interferon in the past, said a Bristol-Myers Squibb letter to doctors. The letter is posted on the Food and Drug Administration’s Web site.