All Heparin Imports Detained, FDA SaysMar 17, 2008 | Parker Waichman LLP
Heparin imports are being halted at the border for inspection and testing, the Food & Drug Administration (FDA) has announced. The FDA made the decision to detain all Heparin imports following reports of adverse reactions and deaths linked to Baxter Heparin.
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. To date, the FDA has received more than 785 reports of Heparin reactions including 19 deaths in patients treated with some brand of Heparin. Baxter said only four fatalities might be related to its Heparin and there was not yet enough data to say the drug was the cause.
In early March, the FDA said its investigators found a contaminant in some batches of the active ingredient used in Baxter Heparin. That ingredient is made by a Chinese facility, as well as a U.S. plant, both owned by Wisconsin-based Scientific Protein Laboratories LLC.
Last week Germany reported that here had been similar reactions to Heparin among dialysis patients in that country. The Heparin involved in the German reactions was made by the German company Rotexmedica. Germany later issued its own Heparin recall. Because of the events in Germany, the FDA cautioned all Heparin manufacturers of the need to conduct specialized nuclear magnetic resonance spectroscopy tests to ensure a safe supply of the blood thinner, derived from an enzyme found in the mucous lining of pig intestines.
On Friday, the FDA announced that it was detaining all Heparin imports and testing them at their points of entry. Five companies have agreed to test for the contaminant, 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. Baxter and APP Pharmaceuticals Inc have been the two major U.S. Heparin suppliers, but other smaller companies manufacture and sell the drug. Both Baxter and APP said they have agreed to the additional testing.