Acute stroke therapy with tissue plasminogen activator (tPA) since it was approved by the US Food and Drug Administration (FDA)

JA Zivin - Annals of Neurology: Official Journal of the American …, 2009 - Wiley Online Library
JA Zivin
Annals of Neurology: Official Journal of the American Neurological …, 2009Wiley Online Library
Tissue plasminogen activator (tPA) for acute ischemic stroke was approved by the US Food
and Drug Administration (FDA) in 1996. Since then it has been severely underutilized. At the
time when most practitioners were first being exposed to the literature concerning tPA, there
were many concerns about safety and the restrictions on use were quite onerous. Since then
a good deal of further work has been done to loosen the restrictions and allay concerns
about the risks. The true risk to benefit ratio is far better than is generally realized. Now it is …
Abstract
Tissue plasminogen activator (tPA) for acute ischemic stroke was approved by the U.S. Food and Drug Administration (FDA) in 1996. Since then it has been severely underutilized. At the time when most practitioners were first being exposed to the literature concerning tPA, there were many concerns about safety and the restrictions on use were quite onerous. Since then a good deal of further work has been done to loosen the restrictions and allay concerns about the risks. The true risk to benefit ratio is far better than is generally realized. Now it is mostly economic problems related to the costs of constantly supplying emergency care that is limiting access. Furthermore, in the current litigious environment, failure to treat is likely to be a more hazardous course of action than legal exposure due to poor outcomes. It must be emphasized that the drug is quite safe and highly effective, and current utilization rates are unacceptably low. Ann Neurol 2009;66:6–10
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