Medico-Legal Aspects of Using Tissue Plasminogen Activator in Acute Ischemic Stroke

Abstract

Intravenous tissue plasminogen activator (tPA) has been approved by the US Food and Drug Administration (FDA) for the treatment of acute ischemic stroke within 3 h of symptom onset since 1996. Despite multiple randomized controlled trials and statistical evidence supporting its efficacy over placebo, there is still some reluctance to use the drug because of the increased risk of hemorrhage [ 1 , 2 •]. However, these risks have been highly exaggerated in the past and the true benefits have been grossly underestimated [ 2 •]. Given the dissension among trained medical professionals and the variations in data interpretation, it is not surprising that there are current concerns over potential litigation involving the use and non-use of the drug.