Friday, March 14, 2008

Imported Heparin to be Tested

Today the FDA ordered the detention of all imported supplies of heparin blood-thinner products so they could be tested for possible contamination. Heparin is derived from pig intestines, and used in dialysis and heart procedures, among other surgeries, to avoid blood clots.

Five companies have agreed to test for the contaminant, which is a chemical similar to heparin, FDA officials said. The agency would not name the companies or say where they are located, but said they represented the majority of the U.S. heparin market.

Source and more here.

Heparin chronology:

On January 17, 2008, Baxter International, Inc., initiated a recall of nine lots of its heparin sodium injection. This recall was initiated after Baxter noticed a severe spike in the reporting of adverse events. The initial recall focused only on multi-dose vials in two sizes: 1000 units/mL 10 mL vials and 1000 unit/mL 30 mL vials. The recall noted that Baxter had not observed significant increases in adverse events to its other heparin products.

-On February 11, 2008, Baxter issued an update on its recall of its heparin products. The update noted that since the initial recall, Baxter was notified of reactions related to lots of heparin sodium injection other than the nine lots recalled (same size as nine lots and different sizes). The update announced that Baxter decided (after discussion with the FDA) to not recall further lots of heparin due to market needs for heparin. While Baxter suspended the manufacture of additional vials, Baxter continued to distribute its existing products. Healthcare professionals were advised to balance the need for heparin with the increased possibility of reaction.

-On February 14th and 15th of 2008, the Wall Street Journal reported that the active ingredient in Baxter's heparin was supplied by a company known as Scientific Protein Laboratories (SPL). SPL maintains facilities in Wisconsin and China. The active ingredient in Baxter’s heparin is manufactured at both facilities. The facility in China was not inspected by the FDA prior to the reported increases in adverse events. The articles did not explicitly link the adverse events to problems with the facility in China.

-On February 28, 2008, Baxter expanded its recall of all remaining lots of all sizes of its multi-dose vials of Heparin Sodium injection, as well as single dose vials, and its heparin lock flush products. The recall notes that Baxter expanded the product removal as a precautionary measure after the FDA confirmed adequate market supply of heparin without Baxter’s presence. The recall notes that despite the expanded recall, the vast majority of adverse reactions reported occurred with Baxter’s multi-dose products. Baxter did not recall its heparin IV bag solutions in this recall.

-On March 5th, 2008, the FDA briefed the media on the Baxter heparin situation. The FDA announced that it discovered a "heparin-like molecule" in the active ingredient in heparin manufactured by Scientific Protein Laboratories (SPL), and supplied to Baxter to make its heparin. This molecule appears similar to heparin, but is considered a contaminant of the heparin. The molecule’s presence was confirmed in both samples of crude heparin (active ingredient only) and in end-product heparin. Because of the molecule's similarity to heparin, routine tests did not detect its presence. The details as to how the molecule found its way into SPL's product are currently unknown. FDA scientists have found that the molecule accounts for 5-20% of the mass of samples tested. According to the FDA, there is an association between the molecule and the severe reactions recently experienced by those taking Baxter heparin. However, the FDA has not yet established a direct causal link. The FDA is continuing to study Baxter heparin and the contamination with this heparin-similar molecule.