Federal regulators have seized contaminated heparin from Celsus Laboratories Inc. in Cincinnati, Ohio. According to the Food & Drug Administration (FDA), the heparin was tainted with over-sulfated chondroitin sulfate, a counterfeit ingredient that mimics heparin’s blood thinning properties.
Heparin was the subject of a major product recall after a potentially lethal contaminant was identified and traced to suppliers in China. In the first quarter of 2008, the FDA received 779 reports of serious injury in which heparin was the principal suspect drug, including 102 deaths.
In January, Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In total, the FDA said tainted heparin has been identified in 12 countries. In the US, the FDA initiated 13 recalls of multiple contaminated medical products containing heparin from several companies
In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. Chondroitin sulfate costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.
Since the heparin recalls, the FDA has implemented an inspection and import controls program and has acted to remove contaminated heparin products from the market. sulfate. The seized Celsus heparin – which had entered the United States before the establishment of import controls for the drug – was tested for the presence of chondroitin sulfate as part of this effort.
According to an agency press release, the FDA informed Celsus Laboratories during an April 2008 inspection and again in a May 8, 2008, letter that the company’s actions to notify customers about a contaminant in its heparin were insufficient to assure an effective recall.
At the FDA’s request, U.S. Marshalls seized 11 lots of heparin from Celsus. This included five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium.
An API is a substance or mixture of substances that, when delivered in a finished drug product, directly affects the structure or function of the body. Heparin Sodium USP is an API that may be incorporated into finished drug products. Heparin Lithium is used in certain medical devices including vacutainer blood collection tubes, some in vitro diagnostic assays, and as a coating for capillary tubes. According to the FDA, Celsus has distributed Heparin Sodium USP and Heparin Lithium to manufacturers in both the U.S. and abroad.
The agency is advising manufacturers who may have purchased heparin from Celsus to contact the company to make certain they are not using any heparin from the seized lots because the product does not meet acceptable quality standards.
The FDA said it has also notified Japanese, Canadian, Australian, European Union, and other international authorities of shipments of contaminated heparin from Celsus.
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