Celgene warns that anticlot drug linked to deaths

[WhiteTara]

http://www.google.com/hostednews/ap/article/ALeqM5gr-v17ESmu21JbL3rsq3mEOF8uOQD95DVR682

TRENTON, N.J. (AP) — Biotech company Celgene Corp. on Wednesday sent a letter to doctors warning that a study of its drug to treat dangerous blood clots suggests it may increase the risk of death in elderly patients.

The letter, posted late Wednesday on the Web site of the Food and Drug Administration, recommends that doctors consider alternatives to Innohep in patients with deep vein thrombosis, life-threatening blood clots in major veins such as in the legs.

The new warning comes after analysis of preliminary data from a study in Europe of patients 70 years old and older — a group often excluded from medical studies — who were diagnosed with deep vein thrombosis and also had failing kidneys.

The study, known by the acronym IRIS, was stopped in February 2008 after 350 of the patients had been followed for three months. By then, 13 percent in the group getting Innohep had died of various causes, versus 5 percent in a comparison group getting heparin, a widely used anticlotting drug.


glad they waited 10 MONTHS before announcing this.