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.
Specifically:
“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contraindicating antithrombotic drugs has been replaced by the term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contraindication has been replaced by the general statement “Current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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