Manufacturer Halts Production of Blood Thinner Heparin

More than one million multiple-dose vials of heparin are sold each month in the United States.

A prepared statement released Monday by Baxter said: "Given the widespread use of this critical anticoagulant (frequently called a blood thinner) and the impact a product shortage would have on operating rooms, dialysis centers and other critical care areas, the removal of Baxter's heparin from the market would create more risk to the population of patients requiring heparin therapy than the increased potential for experiencing an adverse reaction."

Baxter, which is based in Deerfield, Ill., will continue to make its single dose vials of heparin. Adverse events like the ones associated with the multiple dose vials have been reported in a few cases when single dose vials were combined to give a single large dose to a patient, Jenkins said.

The other approved manufacturer of multiple dose vials of heparin, APP Pharmaceuticals of Schaumburg, Ill., is also being checked to see if there has been an increase in the number of adverse reactions with its product, Jenkins said. At this time, APP products have not been associated with these adverse events, he said.

Until the cause of the adverse reactions is known, the FDA is advising doctors to give large doses of heparin through intravenous infusion whenever possible. Doctors should also give the lowest dose at the slowest rate of infusion possible, and patients should be monitored for any sign of an adverse event, Jenkins said.

More information

For more on heparin, visit the U.S. National Library of Medicine.

SOURCES: Baxter HealthCare Corp., Deerfield, Ill., news release; Feb. 11, 2008, teleconference with John Jenkins, M.D., director, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Rockville, Md.