Heparin Deaths Bring Blood Thinner to Spotlight Again

Lewes, DEPatients still reeling from the news of last year's heparin contamination are likely worrying and wondering if there is even more bad news about heparin, following the deaths of 2 people in the last 2 weeks. Although the mode of delivery for heparin in these 2 cases was different from that used in the contamination scare—no heparin injection via heparin syringes in the most recent cases—the deaths have put heparin in the news yet again.

In the most recent cases, the patients were given premixed bags of heparin. Three patients were involved in separate incidents that resulted in the deaths of 2 people. According to Baxter International Inc., all 3 patients suffered bleeding in the brain, known as a cerebral hemorrhage, but were "isolated" and "institution-specific" cases.

The main ingredient in Baxter's Heparin is reportedly supplied by Pfizer Inc. Both Baxter and the US Food and Drug Administration (FDA) said they were reviewing the incidents but had found no evidence that the premixed heparin bags were unsafe. An FDA spokeswoman said that there would likely be additional testing, "but we do not think drug quality is an issue here."

A statement from Baxter said, "the intracranial bleeding was related to underlying medical conditions and risk factors that increase the relative risks involved in using a particular drug." Furthermore, "The supply chain, including raw materials, was examined and found to meet all requirements. All tests on samples obtained from the hospital, retained samples from the same lot, and samples produced before and after the lot in question confirmed that the product's formulation was within specifications and met all requirements."

This is a vastly different outcome than what was experienced a year ago, when it was determined that contaminated heparin was responsible for hundreds of adverse reactions and approximately 80 patient deaths. The contamination affected heparin from multiple companies, not just Baxter. Furthermore, they involved bulk supplies of heparin, heparin vials and drug coated medical devices. Finally, the contaminated heparin was made in China, whereas the premixed bags of heparin were made in North America, with North American ingredients.

In April, the FDA issued a warning letter to Dr. Mao Jian Yi, general manager of the Shanghai No. 1 Biochemical & Pharmaceutical Company, Ltd., in China, regarding the manufacture of heparin. The warning letter cited "significant deviations from U.S. current good manufacturing practices (CGMP) requirements in the manufacture of drugs," and "untrue statements to FDA relating to the manufacture of Heparin Sodium USP."

According to the warning letter, an August, 2008, inspection of the facility found that the heparin sodium was actually produced at 2 other facilities, not at the one listed. Furthermore, inspectors found that the firm did not have adequate testing records for the heparin sodium to prove that batches sent to the US met specifications and the firm did not investigate discrepancies in the heparin sodium lots, specifically the contamination of over-sulfated chondroitin sulfate.

Over-sulfated chondroitin sulfate actually mimics the active ingredient in heparin, making it difficult for quality-control testers to identify. It was reportedly used after because heparin's active ingredient, which comes from pigs, became expensive to use, so over-sulfated chondroitin sulfate was used in its place. Unfortunately, patients suffered severe reactions to the ingredient, resulting in serious injuries and, in some cases, death.

Some patients exposed to the contaminated heparin are now exploring their legal options to determine if they are eligible to join a lawsuit against the makers of heparin.