Baxter's Heparin Production Suspended

Armen Hareyan's picture
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Baxter HealthCare Corp. is suspending production of multiple dose heparin - anticoagulant, which is often called blood thinner.

In December 2007 about 350 adverse cases were registered among patients who had heparin injection, but only in January 2008 the first case was reported by Missouri Department of Health and Senior Services. Patients were found to have allergic reaction within few minutes after injection. At least four of these patients died.

In January Baxter recalled some lots of multi dose heparin, but the adverse reactions were still taking place. Among these reaction researchers note "difficulty breathing, nausea or vomiting, excessive sweating, falling blood pressure."

Heparin is a blood thinner made from pig intestines. It is being used mainly in kidney dialysis procedure to prevent clotting. Without heparin, dialysis patients may loose too much blood. The anticoagulant is also being widely used in heart bypass surgery.

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The U.S. Centers for Disease Control and Prevention, Food and Drug Administration Office of New Drugs and Baxter are investigating cases associated with heparin injection, but they still don't know the reason why allergic reactions happened. They only know that death cases were caused by high dose injection.

"FDA is currently collaborating with Baxter, the CDC and other experts to determine the root cause of the serious adverse events," said Dr. John Jenkins, director of the Food and Drug Administration's office of new drugs. "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."

Since Baxter is producing half of heparin being used in United States, the drug recall will cause difficulties to doctors and those patients having dialysis or surgery. This is why Baxter is allowed to produce single dose vials and to keep multiple dose vials in distributution. The next major heparin producer is APP Pharmaceuticals, which is increasing drug production to avoid statewide shortage. AAP's product was also investigated by FDA, but no adverse reaction was found.

"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.

There are several other drugs that can be used as blood thinners, but none of them is that efficient. Therefore, doctors yet don't have any alternative to heparin and still have to use it. FDA advises doctors to be watchful while using this drug. Only small dose injections are allowed, and the doctors must be prepared to react immediately in case of adverse reactions.

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