Heparin Shortage Looms Following Baxter Heparin RecallFeb 12, 2008 | Parker Waichman LLP
Problems with Baxter heparin have prompted fears of a heparin shortage. Baxter Healthcare Corporation suspended production of multi-dose vials of the blood-thinner heparin following reports of hundreds of patients experiencing severe allergic reactions. Heparin is a vital drug used in surgery, dialysis, and for the bedridden. Other drugs thin blood, but their effects are not as quick or easily reversed. Baxter manufactures about half of all multiple-dose heparin vials sold in the U.S.
The FDA said it received reports of four deaths and about 350 other health problems associated with Baxter's heparin since late 2007; 40 percent were deemed serious. Nearly all adverse reactions were seen in those receiving a "bolus"—or high—doses over short periods. Reactions included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that—in some—led to life-threatening shock. The link to Baxter’s heparin is unclear, according to the FDA, which is investigating if similar problems occurred with heparin made by other manufacturers. Adverse events were not seen in patients receiving lower doses or those who received higher doses over longer periods.
Baxter initially recalled nine heparin lots, but problems continued. Baxter suspended manufacturing the multi-dose vials but continues to make single-dose vials. Baxter 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.
Meanwhile, U.S. regulators 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 said doctors who must use Baxter’s heparin should use the lowest possible dose, infuse it slowly, monitor patients closely, and consider administering steroids or antihistamines before heparin. “There is going to be a shortage problem in the immediate and long-term future with the suspension of Baxter’s manufacturing,” Dr. Jenkins said. “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.