ZymoGenetics Submits Citizen Petition To FDA

Published: 20-Aug-2009

Requesting removal of Bovine Thrombin from market in the interest of patient safety

ZymoGenetics has reported the submission of a Citizen Petition to the FDA, requesting the removal of Thrombin-JMI Thrombin, topical (bovine origin) from the market, in the interest of patient safety.

The Citizen Petition is prompted by recent reports of serious or fatal bleeding-related adverse events in surgical patients, exposed to bovine (cattle-derived) thrombin.

The petition notes that because bovine thrombin is recognized by the body as a foreign protein (and bovine thrombin preparations contain low levels of other coagulation proteins found in cattle plasma ), these products prompt an immune response (formation of antibodies) in a substantial portion of patients exposed to them.

In some patients, these antibodies may interfere with the coagulation process and consequently cause coagulation abnormalities, a condition known as immune-mediated coagulopathy (IMC).

The FDA-approved prescribing information for topical bovine thrombin notes that the risk of antibody formation increases with multiple exposures, and that patients with pre-existing antibodies to bovine thrombin preparations should not be re-exposed to these products.

The petition asserts that the body of evidence from the contemporary medical literature, combined with ongoing spontaneous adverse event reports to FDA, indicate that IMC is a continuing safety risk associated with bovine thrombin, warranting action by FDA.

Reportedly, in the past few years, FDA has approved alternative human thrombin products not derived from cattle plasma, including one made by ZymoGenetics. The petition asserts that the risks associated with use of Thrombin-JMI outweigh the benefits. ZymoGenetics can provide no assurance that the petition will be granted or that Thrombin-JMI will be removed from the market.

George Rodgers, professor of medicine and pathology at the University of Utah, and medical director of the coagulation laboratory at Arup Laboratories, said: “Serious adverse events, including death, linked to bovine thrombin continue to be reported to the FDA. These adverse events are a serious, ongoing safety issue for patients undergoing surgery.”

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