ZymoGenetics Inc. Thursday filed a petition with the U.S. Food and Drug Administration, saying that a rival drug company’s product could cause patients’ deaths and is asking the FDA to remove the drug from the market “in the interest of patient safety.”
The Seattle biotech (NASDAQ: ZGEN) filed a citizen petition, asking the FDA to remove King Pharmaceuticals Inc.’s Thrombin-JMI Thrombin topical (bovine origin) drug from the market because of “recent report of serious or fatal bleeding-related adverse events in surgical patients exposed to bovine (cattle-derived) thrombin.”
“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,” said Dr. George Rodgers, professor of medicine and pathology at the University of Utah, and medical director of the coagulation laboratory at ARUP Laboratories.
A spokesman for King said the Bristol, Tenn. company (NYSE: KG) had “no comment” on ZymoGenetics’ allegations.