Baxter, FDA Look to Chinese Supplier in Heparin ScandalMar 5, 2008 | Parker Waichman LLP
It is becoming more likely that responsibility for tainted Baxter Heparin lies with a Chinese facility that produced a key ingredient for the drug. Last week, a Food & Drug Administration (FDA) finished an inspection of the Chinese supplier, and said that it had found deficiencies at the plant. Now, Both the FDA and Baxter International have said that their investigations have found signs of a possible contaminant in the recalled Heparin that most likely came from an ingredient processed at that plant. Still, neither Baxter or the FDA is ready to place blame for the Heparin debacle with the Chinese facility.
Baxter began recalling Heparin after the FDA reported that, since the end of 2007, it received about 350 reports of health problems associated with Baxter’s multiple-dose injectable heparin; 40 percent were deemed serious and four resulted in death. Reactions included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that—in some—was life threatening. Baxter stopped selling multiple-dose Heparin in early February, and the FDA has advised doctors to prescribe alternatives.
Baxter recalled all of its remaining Heparin products on Feb. 29, after the FDA determined that other suppliers could make up for the lack of Baxter Heparin. By that time, Baxter Heparin had been implicated in more than 400 adverse reactions and at least four deaths.
The FDA inspection of Baxter's Chinese supplier uncovered a variety of problems, which the FDA detailed in a letter to the Chinese company. The FDA cited Changzhou SPL Company, Ltd. for a number of violations, including:
- Incomplete manufacturing instructions
- Lack of critical processing steps or annual test results
- Lack of an impurity profile for Heparin
- Incomplete manufacturing instructions for Heparin Sodium USP
- Investigations into failed lots were approved as complete, but no cause was listed
- Inadequate control of material flow in the processing area
Today, the FDA said its investigators found a contaminant in some batches of the active ingredient used in Baxter Heparin. FDA Deputy Commissioner Janet Woodcock told reporters that the agency has not yet determined if the contaminant was responsible for the Heparin reactions.
For its part, Baxter said today that its own investigation is also pointing to contamination in the ingredient made by the Chinese manufacturer. Baxter said it had found chemical differences in the active pharmaceutical ingredient used in lots of Heparin associated with adverse reactions. That ingredient is made by the Chinese facility, as well as a U.S. plant, both owned by Wisconsin-based Scientific Protein Laboratories LLC. The company said its findings "suggest that the root cause may be associated with the crude Heparin, sourced from China, or from the subsequent processing of that product before it reaches Baxter". Baxter also said that it ruled out its Cherry Hill, New Jersey, facility, where Heparin is manufactured in a later step in the process, as a source of the problem.