Thrombin-JMI regulatory update

ZymoGenetics Inc. (NASDAQ:ZGEN, Seattle Wash.) submitted a Citizen's Petition to FDA requesting the agency remove King's bovine-derived Thrombin-JMI from the market due to safety concerns. In the petition, ZymoGenetics said that antibodies formed in some patients in response to proteins contained in bovine thrombin preparations may interfere with the coagulation process and cause immune-mediated coagulopathy (IMC), a potentially fatal condition. The company noted that more than 25 cases of IMC in patients exposed to bovine thrombin preparations have been published since 2000. The label for Thrombin-JMI, which is approved to control bleeding during surgery, already contains a boxed warning regarding the risk of IMC. King declined to comment. ...