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Manufacture of Heparin Halted Due to Serious Allergic Reactions in Patients

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The U.S. Food and Drug Administration has announced that Baxter Healthcare Corporation has temporarily stopped manufacturing the injectable blood-thinner drug heparin due to reports of serious allergic reactions and low blood pressure in patients who receive high doses of the drug.

According to an FDA spokesperson, confusion over two Chinese factories with similar names led to a failure to inspect a plant that makes an ingredient linked to life-threatening side effects with the blood-thinning drug.

Reportedly, FDA regulators mistakenly referred to inspection records for a plant from a different company and cleared the heparin facility without necessary inspections.

Serious reactions to the drug have included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that can lead to life-threatening shock. Four people have died after receiving heparin.

About 350 adverse events associated with the Baxter product have been reported since the end of last year compared to less than 100 reports in 2007, according to the Agency.

The FDA recommends that physicians, dialysis center staff and health care providers use an alternate source of heparin or another blood-thinning drug when possible.

If you were harmed after being administered heparin, please complete the form below and a representative of our firm will contact you as soon as possible.

see also:

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