What has FDA announced about heparin since Baxter’s recalls?
(answer revised 7/3/2008) After launching a disciplined, methodical examination, FDA scientists have identified a previously unknown contaminant in heparin active pharmaceutical ingredient (API) from China. The contaminant is oversulfated chondroitin sulfate. The contaminant activates enzymes that can generate inflammatory mediators (N Engl J Med 358;23 June 5, 2008 p2457). These mediators (chemicals that are released by immune cells) can lead to many of the observed symptoms such as low blood pressure, abdominal symptoms and shortness of breath. This provides additional support to the association of the adverse events with oversulfated chondroitin sulfate. The agency has made available information on two tests that FDA scientists have conducted to detect the contaminant in heparin and recommend their use to manufacturers and suppliers for screening the heparin API. 9. What is an Active Pharmaceutical Ingredient or API? (new question and answer added 6/18/2008) An API or active pharmac
