Heparin Contamination Worries Not Over for Baxter
Last week, three patients in a Delaware hospital, each of whom received Heparin, a blood thinner distributed by Baxter International Inc., suffered intra cranial bleeding. Baxter insists that the injuries, while unfortunate, are not related to the quality of its Heparin product.
Heparin, an anticoagulant used to decrease the clotting ability of blood, is used to treat blood clots in the veins, arteries and lungs. It is also used in some surgeries to prevent the formation of blood clots. In January 2008, increased complaints to the FDA of serious allergic reactions to Heparin were traced to contaminated Heparin distributed by Baxter International. The contaminant, known as oversulfated chondroitin sulfate (OSCS), can lead to death and serious injury, including low blood pressure, abdominal symptoms and shortness of breath. On February 28, 2008, Baxter recalled all of its multi-dose and single-dose vials of Heparin and HEP-LOCK flush products.
Also last week, the FDA issued a second Form 483, Notice of Inspectional Observations, to Scientific Protein Laboratories (SPL), citing six violations of Good Manufacturing Practices (GMP), including failure to follow safety procedures regarding the cleaning of equipment used in the manufacture of Heparin and failure to follow up on known reported deficiencies of material suppliers. SPL was the supplier of the component ingredients in the contaminated Heparin distributed by Baxter International.
