First Signs of a Problem: Background Information

The FDA first became aware of a potential problem with heparin late last year when dozens of blood infections were linked to heparin-filled syringes.  The actual recall of the drug though, was triggered by the discovery and concurrent report filed by one St. Louis doctor.  In early January, Dr. Alexis M. Elward at St. Louis Children's Hospital discovered several children undergoing dialysis had suffered an allergic reaction to the prescription anticoagulant heparin.  She alerted the government who in turn alerted the medical community.  Due to a high number of similar reports, the FDA urged a preventative recall of the drug prompting Baxter to subsequently recall a portion of the heparin lots, pending further investigation.

On January 25, nine lots of heparin sodium injection multi-dose vials, sizes 1000 units/mL in 10 mL vials and 1000 units/mL in 30 mL vials, were voluntarily recalled by Baxter Healthcare Corporation.

By February, hundreds of  reports detailing severe reactions to heparin surfaced worldwide, leading officials to assume the drug tainted, and therefore unsafe. In the U.S., a reported 19 deaths were being attributed to the drug.  This led Baxter to issue the recall of all of its remaining heparin products, including HEP-LOCK heparin flush products, on February 28.

At the time, nearly all reported adverse reactions had occurred in three specific areas of product use B renal dialysis, invasive cardiovascular procedures and apheresis procedures.  Peter J. Arduini, president of Baxter's Medication Delivery business stated, "The safety and quality of our products is always our highest priority, and we will continue to collaborate with the FDA as we work to determine the cause of the increased rate of adverse reactions and resolve this issue."

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