November 10, 2008
Ten months after recalling large amounts of the Chinese blood-thinning
drug heparin because of contamination, the U.S. Food and Drug
Administration has discovered some of it is still on the market.
In response, U.S. Marshals seized five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium from Celsus Laboratories Inc. in Cincinnati.
These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity.
"This action will help prevent this contaminated heparin from finding its way into the marketplace," said Mike Chappell, acting associate commissioner for regulatory affairs, FDA.
Doctors outraged
WTOL-TV in Toledo interviewed a number of Ohio doctors who expressed shock and outrage at the revelations.
"It's really horrible for two reasons: one, that a company that knows that their product is not a good product that should be distributed and they've been told so," said Dr. Lynne Wagoner, a Christ Hospital Heart Specialist. "This contaminate called chondrotin sulfate, when combined with heparin, has a super additive effect, so that's leading to strokes."
Heparin is a blood-thinning drug. 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. Celsus has distributed Heparin Sodium USP and Heparin Lithium to manufacturers in both the United States and abroad.
Multiple problems
OSCS contaminant in injectable drug products containing heparin has been linked to multiple adverse events and deaths initially reported to the FDA in January 2008.
Since then, the FDA has put in place a comprehensive inspection and import controls program and has acted to remove from the market heparin materials and products contaminated with OSCS. 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 OSCS as part of this FDA effort.
To date, the agency has initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.
The FDA said it 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.
The agency advises 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 has notified Japanese, Canadian, Australian, European Union, and other international authorities of shipments of contaminated heparin from Celsus.
