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Saturday, January 07, 2006

Bleeding Disorder Patients Warned

A small number of patients with a bleeding disorder have experienced a potentially life-threatening loss of red blood cells, the FDA and the manufacturer and distributor of a medicine that treats the disorder warned Friday.

Patients with immune thrombocytopenic purpura, or ITP, should immediately alert their doctors if they experience back pain, shaking or chills, fever, discolored urine or decreased urine output, sudden weight gain, fluid retention, swelling or shortness of breath, Baxter Healthcare Corp. and Cangene Corp. said.

The rare but sometime severe or fatal symptoms have been observed in ITP patients, the companies wrote in a letter to doctors last month. Reports of the most severe reactions occurred in patients treated with WinRho SDF, a medicine made and distributed by the two companies. Most reported adverse reactions within four hours of treatment, the companies said. The Food and Drug Administration released the letter Friday.


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