FDA Advisory - Temporary
Suspension of Multiple-dose Vial Heparin
The U. S. Food and Drug Administration (FDA) announced yesterday that
Baxter Healthcare Corporation (Baxter) has temporarily stopped
manufacturing
multiple-dose vials of the injectable blood-thinning drug Heparin due
to reports of
serious allergic reactions and hypotension in adult and pediatric
patients who receive
high doses of the drug. The first reports of severe reactions
took place in
pediatric dialysis patients.
The FDA is investigating these adverse events and is working closely
with Baxter to inspect manufacturing sites. They are also working
with other
manufacturers to prevent any inventory shortfall.
For your information, we have provided a link to the official FDA
Advisory which clearly summarizes the issue and outlines recommended
actions for
physicians, dialysis center staff and health care providers.
