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Misadministration of Topical Bovine Thrombin
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To the Editor: The Center for Biologics Evaluation and Research at the Food and Drug Administration (FDA) has received reports through MEDWATCH of 3 fatalities and 1 serious but nonfatal adverse event following the improper administration of topical thrombin (bovine origin) USP by several inappropriate methods.
Report of Cases
The first report was received in April 1987. A physician injected topical thrombin (Thrombostat, Parke-Davis) directly into the splenic tissue of a 61-year-old patient with a perforated colon. The patient developed immediate anaphylactic-like shock and died 1 hour later. The second serious but nonfatal report was received in October 1996. A surgeon mistakenly administered 3000 U of Thrombin-JMI (GenTrac Inc) into the catheter of a 69-year-old patient with renal failure, who was being prepared for hemodialysis. The patient developed severe hypotension, bradycardia, and respiratory failure—requiring intubation and assisted ventilation. The patient recovered a week later but also developed pulmonary emboli. The patient was released . . . [Full Text of this Article]
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