Chinese Drug Maker Responsible for Tainted Baxter Heparin Never Inspected by FDAFeb 14, 2008 | Parker Waichman LLP
The Baxter heparin plant in China that produced the tainted drug was never inspected by U.S. regulators. Earlier this week, Baxter halted sales of some versions of the heparin drug following the deaths of four patients and reports of hundreds more falling ill from severe allergic reactions to Baxter’s heparin. That same day, the Food & Drug Administration (FDA) warned doctors to avoid using the defective Baxter heparin. The FDA heparin warning and Baxter’s decision to cease production of the drug came just weeks after the company had recalled several heparin lots following reports of serious allergic reactions.
The FDA did not say why the Chinese plant that makes the Baxter heparin was not inspected, but plans to correct the oversight. "Preparations are being made to perform an inspection as soon as possible," according to FDA spokeswoman Karen Riley. Meanwhile, Baxter claims it inspected the facility within the last six months and plans another inspection in the near future.
Heparin is a blood thinner that is administered in surgery and other critical care areas to prevent blood clots. Heparin is crucial in dialysis and heart surgery, and is used for the bedridden. Other drugs thin blood, but their effects are not considered to be as quick or as easily reversed. Heparin, which has been manufactured since 1930, is administered to millions of patients yearly and Baxter manufactures about half of all multiple-dose heparin vials sold in the U.S.
On Tuesday, 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. Reactions included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that—in some—led to life-threatening shock.
Baxter initially recalled nine heparin lots, but problems continued and Baxter was forced to suspend manufacturing the multi-dose vials. Baxter continues to make heparin single-dose vials and says it is not recalling additional lots because to do so might cause a shortage and create more of a risk to patients requiring heparin therapy than the increased potential for an adverse reaction.
U.S. regulators have advised doctors to consider alternatives to Baxter’s heparin as shortages are expected. While alternatives exist, doctors warned there could be serious consequences if heparin becomes scarce. “Inadequate heparin would cause a health care crisis in this country,” said Dr. Daniel Coyne, a professor of medicine at Washington University in St. Louis. Dr. John Jenkins, director of the FDA’s office of new drugs, said the FDA allowed Baxter to continue distributing the multi-dose vials it had made because a full recall “would result in an immediate and severe shortage of this medically necessary drug.” Jenkins added, “There is going to be a shortage problem in the immediate and long-term future with the suspension of Baxter’s manufacturing. Facilities and physicians will have to decide immediately what they do with the heparin on hand, and they’ll have to start looking for heparin for the long term.”
Doctors said they would face difficult choices if heparin supplies ran low. “It’s an essential part of dialysis treatment,” said Dr. Jay Wish, professor of medicine at Case Western Reserve. Without heparin, many more patients would likely experience significant blood loss, worsening their chronic anemia, Wish warned. “Trying to operate without heparin would be a scary proposition for the dialysis industry,” Wish said.