TachoSil Adverse Reactions

Clinical Trials Experience: From six controlled trials, 521 patients were treated with TachoSil and 511 patients treated with comparator treatment. The only individual adverse events reported in more than 5% of patients in either treatment group were atrial fibrillation (32 patients [6.1%] in the TachoSil group and 30 patients [5.9%] in the comparator group) and pyrexia (30 patients [5.8%] in the TachoSil group and 25 patients [4.9%] in the comparator group).
A summary of all adverse events reported by at least 1% of patients and a classification of their severity is shown in the table as follows. There are no notable differences in the severity of adverse events between the treatment groups and the majority of adverse events reported were mild or moderate in severity. (See table.)

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Immunogenicity: Antibodies against components of fibrin sealant/hemostatic products may occur rarely.
However in a clinical trial with TachoSil in hepatic surgery 26% of the 96 patients tested and treated with TachoSil developed antibodies to equine collagen. The equine collagen antibodies that developed in some patients after TachoSil use were not reactive with human collagen. One patient developed antibodies to human fibrinogen.
There were no adverse events attributable to the development of human fibrinogen or equine collagen antibodies.
There is very limited clinical data available regarding re-exposure of TachoSil. Two subjects with unknown antibody status to collagen or fibrinogen have been re-exposed in a clinical trial and have not reported any immune-mediated adverse events.
Postmarketing: Following is a list of ADRs which have been observed in postmarketing and are not included previously: Immune system disorders: Anaphylactic shock, hypersensitivity.
Vascular disorders: Thrombosis.
Gastrointestinal disorders: Intestinal obstruction (in abdominal surgeries), ileus (in abdominal surgeries).
General disorders and administration site conditions: Adhesions.