Bad Heparin Seized by FDA from Drug Maker in Ohio

At the request of the FDA, U.S. Marshalls seized 11 lots of contaminated heparin yesterday from Celsus Laboratories, Inc. in Cincinnati, Ohio. The bad heparin contained raw ingredients from China which have been found to be tainted with a fake chemical that has already sickened or killed hundreds of people in the United States this year.

The tainted heparin included 5 lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and 6 lots of Heparin Lithium. They were both found to be contaminated with over-sulfated chondroitin sulfate (OSCS), which is a counterfeit substance that mimics an active ingredient in heparin.

Around November 2007, the FDA started receiving a spike in adverse event reports involving heparin, where users were suffering severe and potentially fatal allergic reactions to the blood thinner. Subsequent investigations found that nearly half of the U.S. supply of heparin in late 2007 and early 2008 contained the counterfeit ingredient, which was causing the heparin problems.

In the first quarter of 2008, the FDA received 779 reports of heparin reactions resulting in serious injury, including 102 deaths. Symptoms of the severe allergic reactions to the bad heparin included nausea, difficulty in breathing, excessive sweating, vomiting and rapidly falling blood pressure.

The contaminated raw heparin ingredients were supplied by Changzhou SPL, which operates a Chinese plant that is partially owned by Wisconsin-based Scientific Protein Laboratories.

There have been at least 13 different heparin recalls throughout the United States this year caused by over-sulfated chondroitin sulfate, including the recall of all lots of the blood thinner sold by Baxter International.

Following the recalls, the FDA has implemented much tighter controls on heparin imports, inspected company facilities and acted to remove contaminated heparin products from the market. The Celsus heparin which was seized this week, entered the United States before these import controls were put in place.

 
In April 2008 and May 2008, the FDA notified Celsus Laboratories about the bad heparin and required the company to inform its customers about the defective product. However, after Celsus failed to effectively recall the heparin, the FDA seized the bad blood thinner and is contacting manufacturers who may have purchased heparin from Celsus to make certain they are not using any of the blood thinner from the seized lots.