Abstract Details

Title Potentially Fatal Adverse Allergic Events to Intravenous Thrombolytics: An Analysis from Adverse Event Reporting System

Topic Cerebrovascular Disease and Interventional Neurology

Presentation(s) P04 - (-)

Poster/Presentation
Number 078

Objective

Background BACKGROUND: Adverse Event Reporting System (AERS) is a database of adverse events and medication error reports submitted to FDA, which supports the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products.

Design/Methods DESIGN/METHODS: A systematic review of AERS was performed for allergic adverse events occurring in conjunction with IV thrombolytics, including alteplase, tenecteplase, urokinase and reteplase. Allergic reaction was defined as any non-hemorrhagic sensitivity reaction which occurred as a direct result of administration of IV thrombolytic. We reviewed 924 adverse events which occurred between 2004-2010 associated with thrombolytics and further requested 33 detailed ISR reports of allergic reactions.

Results RESULTS: Of the 33 reports, there were 12 cases (age range 57 to 93 years) of adverse allergic reaction directly attributable to IV thrombolytics. Allergic reactions included angioedema, facial swelling, urticaria, skin rash, cutaneous hypesthesia, hypotension, seizure, anaphylactic shock and death. Of the patients who suffered from allergic adverse events, 11 received IV alteplase, and 1 received IV reteplase. Four of these patients were taking ACE inhibitors at the time of allergic reaction. In the remaining 21 events, IV thrombolytics remained as a possible secondary cause of allergic reaction, but concomitantly administered medications made this difficult to ascertain. Most reactions resolved with withdrawal of medication and treatment with diphenhydramine and steroids +/- epinephrine. There was 1 death directly attributable to allergic reaction in a patient who received IV reteplase for MI.

Conclusions CONCLUSIONS: Although IV alteplase is identical to endogenous tissue plasminogen activator, it appears to be the most common cause of allergic reaction amongst currently used thrombolytics, with or without concomitant administration of ACE inhibitors. A greater awareness among physicians may result in prompt recognition and treatment.

Authors/Disclosures
Asif A. Khan, MD (Neurosurgical Specialists North Florida) PRESENTER	No disclosure on file
	No disclosure on file
	No disclosure on file
Hamza I. Maqsood, MD (Dept of Neurology)	Dr. Qureshi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for AstraZeneca.
	No disclosure on file

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