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Suspected Heparin Dosing Issue

from SCAI

The Food and Drug Administration (FDA) is interested in learning more about recent reports of dosing issues with unfractionated heparin. Some interventionalists have noted higher than expected doses are occasionally needed to attain targeted activated clotting time (ACT) during percutaneous coronary interventions and other cardiac procedures.

To establish the scope of the issue and identify any patterns, members are strongly encouraged to note and report dosing issues through the FDA’s MedWatch reporting tool.

If you observe any issues with heparin dosing, please record the following information:
  • Product name
  • National Drug Code (NCD) number, lot number, expiration date Photo of the product vial (front view and view with lot number and expiration date)
  • Dosage delivered and patient weight
  • Lab values (particularly ACT numerical value and note of hemoTec, hemochron, etc.)
  • Concomitant antiplatelet or other anticoagulants concurrently administered
  • Clinical sequelae
FDA reviews MedWatch reports and may request additional information, including a sample. If you suspect the quality or potency of a heparin product, you should report the problem to FDA via MedWatch and to the manufacturer directly. If you suspect a drug quality problem with heparin, we encourage members to retain any vials with remaining suspect product. If you have a sample of the suspect product, please email after you have submitted the MedWatch form for this event. If you conduct any testing of heparin finished product within your own hospital or independent laboratory to verify the label claim, including purity or activity of heparin, FDA encourages you to report those results to MedWatch.

The SCAI Quality Improvement Committee is monitoring this issue closely and will share additional information as available. more

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