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Heparin Controversies

Contamination recalls

In December 2007, the U.S. Food and Drug Administration (FDA) recalled a shipment of heparin because of a growth of Serratia marcescens in several unopened syringes of this product. The bacteria Serratia marcescens can lead to life-threatening injuries and/or death.

In March 2008, major recalls of heparin were announced by the FDA due to contamination of the raw heparin stock imported from China. According to the FDA, the contaminated heparin killed 81 people in the United States. The contaminant was identified as an "over-sulphated" derivative of chondroitin sulfate, a popular shellfish-derived supplement often used for arthritis.

Use in homicide

In 2006, Petr Zelenka, a nurse in the Czech Republic, deliberately administered large doses to patients, killing 7, and attempting to kill 10 others.

Overdose issues

In 2007, a nurse at Cedars-Sinai Medical Center mistakenly gave actor Dennis Quaid's twelve-day-old twins a dose of heparin which was 1,000 times the recommended dose for infants. The overdose allegedly arose because the labeling and design of the adult and infant versions of the product were similar. The Quaid family subsequently sued the manufacturer, Baxter Healthcare Corp., and settled with the hospital for $750,000. Prior to the Quaid accident, six newborn babies at Methodist Hospital in Indianapolis, Indiana were given an overdose. Three of the babies died after the mistake.

In July 2008, another set of twins born at Christus Spohn Hospital South, a hospital located in Corpus Christi, died after an accidentally administered overdose of the drug. The overdose was due to a mixing error at the hospital pharmacy and was unrelated to the product's packaging or labeling. , whether the deaths were due to the overdose is under investigation.

Further Reading


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