Monday, May 18, 2015

Revised TPA contraindications in acute ischemic stroke

The labeling changes are summarized here in a post from Emergency Medicine PharmD.

In general the contraindications have eased and there are now vague statements open to wider ranges of interpretation.


“Evidence of intracranial hemorrhage on pretreatment evaluation” has been replaced with “Current intracranial hemorrhage.” The new wording here apparently means the FDA intends a change but it's a mystery to me what the change actually is.

“Suspicion of subarachnoid hemorrhage” has been replaced with “Subarachnoid hemorrhage,” thus ignoring the slight possibility that a patient with a sudden severe headache could have SAH despite a negative CT. Has the FDA decided this is a chance worth taking? After all, no one is going to do an LP before treating with TPA.

Prior stroke (implied in the old labeling to have been within three months) has been eliminated from the contraindications.

“Intracranial neoplasm, arteriovenous malformation, or aneurysm” is replaced with “Presence of intracranial conditions that may increase the risk of bleeding (e.g., some neoplasms, arteriovenous malformations, or aneurysms),” implying that there may be other intracranial contraindicating conditions and some neoplasms that are not contraindications.

A list of specific coagulopathies and contraindicating antithrombotic drugs has been replaced by the term “Bleeding diathesis.”

The specific blood pressure contraindication has been replaced by the general statement “Current severe uncontrolled hypertension.”

Seizure at presentation and history of intracranial hemorrhage have been eliminated from the contraindications.

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