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Baxter Says Heparin Not to Blame for Delaware Reactions, Deaths

May 15, 2009 | Parker Waichman Alonso LLP

Baxter International says the quality of its heparin was not to blame for serious complications in three patients at a Delaware medical center last week.  According to Baxter, product testing has cleared its blood thinner.

The incidents - which involved two fatalities - had re-ignited fears about potentially tainted heparin.  In 2008, Baxter recalled prefilled heparin vials after they were linked to serious, and sometimes fatal, allergy-type reactions in some patients.  There were similar recalls by other manufacturers in Denmark, Italy, France, Germany, and Japan.  In total, tainted heparin was identified in 12 countries.

It was eventually determined that a counterfeit ingredient in Chinese-sourced heparin was to blame for the problems.  The Centers for Disease Control (CDC) ultimately identified 152 adverse reactions associated with heparin in 113 patients from November 19, 2007 through January 31, 2008. What’s more, the agency said heparin manufactured by Baxter “was the factor most strongly associated with reactions.”

Baxter hasn't made heparin vials since the 2008 recall.  The patients involved in the incidents at  Delaware's Beebe Medical Center received heparin from pre-mixed IV bags.  According to the Associated Press, unlike the heparin involved in the recall, the active ingredient for the heparin the Beebe patients received was supplied by Pfizer.  The pre-mixed bags were finished at Baxter's plant in Puerto Rico.

The three patients at Beebe suffered intracranial bleeding.  They all had to be airlifted to nearby medical centers, and two died.  The Food & Drug Administration (FDA) and officials from Baxter had been at Beebe investigating the incidents.

Today, Baxter released a statement that said  intracranial bleeding the patients suffered “was related to underlying medical conditions and risk factors.”  The letter said the heparin "performed exactly as intended, and … the events were not related to a quality product issued."

According the Associated Press, the FDA is expected to release a statement on the Beebe heparin investigation soon.