Baxter Heparin Issues Could Boost Sales of Alternative Blood ThinnersFeb 21, 2008 | Parker Waichman LLP
Problems with Baxter Heparin have hospitals and doctors scrambling to find alternatives to the blood thinner. Sales of non-Heparin blood thinners could increase if Baxter's suspension of its multi-dose vials Heparin leads to a significant shortage, as has been feared. Heparin production was halted by Baxter following reports of hundreds of patients experiencing severe allergic reactions. Heparin is used in surgery, dialysis, and for the bedridden. Other drugs thin blood, but their effects are not as quick, easily reversed, and broadly appropriate. 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.
GlaxoSmithKline PLC, Sanofi-Aventis, and the Medicines Company are a few companies manufacturing other blood thinners which could be substituted for Heparin, but only in limited circumstances, according to doctors, drug makers, and the federal government. The U.S. Food and Drug Administration (FDA) cautioned about alternatives to Heparin on its Website saying, "There is no experience with the other anticoagulants to achieve the immediate anticoagulation needed for" dialysis and certain cardiac procedures. The FDA said it's working with APP Pharmaceuticals Inc. and others to increase production of heparin sodium. Hospira Inc. and B. Braun Medical Inc. also supply some heparin sodium for injection.
Still, doctors may have to seek alternatives and one is another form of Heparin known as "low-molecular-weight heparin." A popular version is Lovenox from Sanofi-Aventis and is approved to prevent a type of blood clot known as deep-vein thrombosis in surgeries and to prevent heart attacks in some situations. The drug "could be used interchangeably for the vast majority of patients" with those diagnoses, said Charles Francis, hematologist and professor of medicine at University of Rochester School of Medicine in Rochester, N.Y. "The place where others would have trouble is cardiac bypass surgery," where heparin is used in high doses, Francis said.
Arixtra from the U.K.'s GlaxoSmithKline, is approved to prevent blood clots in some surgeries and treat clots in certain situations. "It has some advantages and would be an alternative for many indications," Francis said. Spokeswoman Mary Anne Rhyne said there is some overlap between approved uses for the drugs, but "Heparin is approved for a wide range of uses." Direct thrombin inhibitors such as Angiomax from Medicines Co., Refludan from Bayer AG, and Argotroban from GlaxoSmithKline could be used in some situations. Angiomax, is approved to help prevent clots when stents are inserted to prop open arteries and can treat a Heparin side effect called thrombocytopenia.
Other factors could limit alternatives. "They're very expensive," said Patrick McCarthy, head of cardiothoracic surgery at Northwestern Memorial Hospital in Chicago. "We try not to use them. I don't honestly even know if they'd be made in the kind of quantities we'd need if there was a shortage of heparin."
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. Reactions included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that—in some—led to life-threatening shock and, in others, led to death.