"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is warning of several treatment-related serious adverse events in association with implantable left ventricular assist devices (LVADs) in heart-failure patients.
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In clinical trials, inadvertent overdosage with AGGRASTAT occurred in doses up to 2 times the recommended dose for initial infusion doses. Inadvertent overdosage occurred in doses up to 9.8 times the 0.15 mcg/kg/min maintenance infusion rate.
The most frequently reported manifestation of overdosage was bleeding, primarily minor mucocutaneous bleeding events and minor bleeding at the sites of cardiac catheterization [see WARNINGS AND PRECAUTIONS].
Overdosage of AGGRASTAT should be treated by assessment of the patient's clinical condition and cessation or adjustment of the drug infusion as appropriate.
AGGRASTAT can be removed by hemodialysis.
AGGRASTAT is contraindicated in patients with:
- Severe hypersensitivity reaction to AGGRASTAT (i.e., anaphylactic reactions) [see ADVERSE REACTIONS].
- A history of thrombocytopenia following prior exposure to AGGRASTAT [see ADVERSE REACTIONS].
- Active internal bleeding or a history of bleeding diathesis, major surgical procedure or severe physical trauma within the previous month [see ADVERSE REACTIONS].
Last reviewed on RxList: 11/6/2013
Additional Aggrastat Information
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