Heparin Recall

Celsus Laboratories Heparin Linked to Adverse Events

On Novemebr 6, 2008 the U.S. Food & Drug Administration seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio.

According to the FDA, “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. 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 also notified Japanese, Canadian, Australian, European Union, and other international authorities of shipments of contaminated heparin from Celsus.

What’s the problem?

The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA’s request by U.S. Marshals. 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.

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.

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.

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Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events. Here is an update and recommendations on this continuing issue.

Heparin is an anticoagulant commonly used subcutaneously and intravenously in patients undergoing kidney dialysis, certain types of cardiac surgery and other procedures. It is also used in lock flush solutions to maintain the patency of IV catheters, and as a coating or ingredient in certain medical devices and diagnostic products.

Towards the end of 2007, FDA started receiving an increasing number of reports of adverse events associated with injectable heparin products, especially when the heparin was administered as a bolus dose. Many of these events were consistent with either an anaphylactic-type reaction or acute hypotension. A small number of similar events have also been reported for heparin flush solutions. FDA has identified a contaminant in the heparin, an oversulfated chondroitin sulfate, that may have led to the adverse events.

This contaminant mimics heparin activity so closely that routine testing did not uncover it. Special test methods are needed to detect this contaminant, and the major U.S. heparin manufacturers and suppliers have agreed to perform these tests to screen all heparin active ingredient that they receive.

FDA has also asked medical device companies to identify any product they market that contains heparin or uses heparin in processing. A number of companies have recalled heparin or products containing heparin. They did this based either on reports of adverse events or as a precaution after the special testing revealed that the company had been supplied with contaminated lots of heparin.

FDA is asking healthcare professionals and facilities to take the following steps:

• Report adverse reactions associated with any drug or device that contains heparin. FDA is continuing to actively monitor this situation and it is essential that new events are reported as soon as possible. FDA is focusing on events involving injectable heparin, heparin lock flush solutions or medical devices that contain heparin. That could include certain blood collection tubes, intravascular catheters, vascular stents and grafts, and other devices used during cardiac procedures, such as oxygenators, pumps, filters and blood reservoirs.
• Pay attention to recalls of heparin or heparin-containing products, including those by Baxter Healthcare, American Health Packaging, B. Braun, Covidien, Medtronic and Atrium Medical.
• Check all drug and device storage areas, including emergency kits, crash carts, dialysis units and automated drug storage cabinets, to make sure that all recalled heparin products have been removed and are no longer available for use.

The investigation of contaminated heparin is still underway. The links (see “Additional Information” below) will be updated with the latest information as it becomes available.

Additional Information

FDA. Update to healthcare facilities and healthcare professionals about Heparin and Heparin-containing medical products.
http://www.fda.gov/cder/drug/infopage/heparin/default.htm#healthcare

FDA. Information on Heparin Sodium Injection. April 25, 2008.
http://www.fda.gov/cder/drug/infopage/heparin/default.htm

FDA MedWatch Safety Alert. Heparin Sodium Injection. May 15, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeparinInj2