Surgeons have been warned not to use the sealant product Quixil for unlicensed indications. This follows reports of toxicity.
Quixil is a fibrin sealant licensed for use for facilitating haemostasis and reducing bleeding during liver surgery. It contains human clottable protein and thrombin, and a number of excipients, including glycine, arginine and tranexamic acid. In a letter sent recently to doctors, the chairman of the Committee on Safety of Medicines (Professor Alasdair Breckenridge) says that, since licensing in September, there have been two reports of fatal reactions associated with its use in neurosurgical procedures. The cases involved a severe neurotoxic reaction. Professor Breckenridge "strongly advised" doctors not to use the product other than for liver surgery.
Omrix Biopharmaceuticals, the Belgian manufacturer of Quixil, said on November 15 that it had initiated studies on the toxicological effects of the product. It added that, on the evidence currently available, it did not consider that the events reported were related to use of Quixil.