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Manufacturer Halts Production of Blood Thinner Heparin
Date:2/11/2008

f heparin before undergoing dialysis or heart surgery. The problem was first reported to the U.S. Centers for Disease Control and Prevention in January by the Missouri Department of Health and Senior Services, which had seen several cases in one pediatric hospital starting in November, the FDA said.

The CDC alerted the FDA and Baxter, which started a voluntary recall of the affected lots of heparin Jan. 17. Since that time, however, adverse reactions have been found in other lots of Baxter's multi-dose heparin, which led to Monday's suspension of production.

"FDA is currently collaborating with Baxter, the CDC and other experts to determine the root cause of the serious adverse events," Jenkins said. "Investigators and scientists are conducting inspections of all facilities and processes involved in the manufacture of Baxter's heparin. FDA investigators and scientists are also conducting tests of samples of Baxter's product."

Baxter's suspension of production of multi-dose vials of heparin could lead to a shortage of the drug, Jenkins said. "The FDA is working with other manufacturers of heparin to fill the void that will occur if the Baxter manufacturing suspension continues," he said.

It's not clear how long production will be stopped, so doses of Baxter's multi-dose heparin already in the hands of hospitals and clinics will not be recalled, Jenkins said.

"A recall would result in an immediate and severe shortage of this medically necessary drug. FDA has concluded that it is better for the public health to allow the Baxter multiple dose vials of heparin to remain in distribution," Jenkins said.

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,
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