Baxter Heparin may have killed as many as 21 patients, according to the Food & Drug Administration (FDA), and the number of adverse reactions tied to the tainted Heparin has risen to 448. The FDA also said that its inspectors have found “potential deficiencies” at a Chinese plant that supplied much of the active ingredient for Baxter Heparin. Last week, Baxter International, Heparin’s manufacturer, announced it was expanding its Heparin recall to include most Heparin products.
Baxter began recalling Heparin late last month, 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 vials earlier this month and the FDA has advised doctors to prescribe alternatives.
Though Baxter produces much of the heparin used in the US, regulators said the other major supplier would be able to meet the demand, a change from concerns expressed last month over shortages.
The FDA has not identified the root cause of the problem and said it was investigating two Chinese wholesalers — also called consolidators — that supplied crude heparin to Changzhou SPL, as well as those that sold raw ingredients to consolidators. At least one consolidator received supplies from small, unregulated family workshops where conditions are questionable and, in many cases, unsanitary. The FDA admitted this month it had violated its own policy by failing to inspect SPL before it began shipping the Heparin ingredient to Baxter in 2004. China’s drug agency did not inspect the plant.
Last week, the agency sent inspectors to the plant and found a failure to properly follow the steps for identifying impurities and deficiencies related to manufacturing equipment. According to an inspection report released by the agency, the SPL plant appeared to have made at least some heparin with “material from an unacceptable workshop vendor.” Scientific Protein Laboratories (SPL), a Wisconsin company that is the majority owner of the Chinese plant, argued that the FDA’s finding did not represent its final determination as to whether the plant complied with federal regulatory rules. Erin Gardiner, a spokeswoman for Baxter, said the company was reviewing the FDA’s report adding, “We expect SPL to respond to those observations thoroughly and promptly.”
The FDA’ concern about Heparin had focused on Baxter’s multidose vials, which were recalled. Baxter has since recalled single-dose vials and a diluted solution of Heparin used to keep blood clots from forming in intravenous lines. The only Baxter Heparin products available are premixed bags of intravenous solutions, the FDA said. The FDA estimates over one million multidose vials of heparin are sold monthly in the US; about half are manufactured and distributed by Baxter.
The Chinese heparin market has been in turmoil over the last year, as pig disease has swept through the country, depleting stocks, leading some farmers to sell sick pigs into the market; even big companies have turned to small village workshops, which are often unsanitary and not inspected.