Further Expansion of Recall of Contaminated Heparin

Baxter Healthcare Corporation recently notified healthcare providers of an expansion of its recall of various blood thinner products. The February 28, 2008, expansion includes all lots of HEP-LOCK (Heparin Lock Flush Solution) and HEP-LOCK U/P (preservative-free Heparin Lock Flush Solution). These products were included in the expansion of the recall due to concerns about potential contamination since the crude heparin utilized to manufacture the products is supplied by the same Chinese facilities and American wholesaler implicated in the earlier recalls in January and February of 2008.

Baxter’s latest recall notice indicates: “Nearly all reported adverse reactions have occurred in three specific areas of product use – renal dialysis, invasive cardiovascular procedures and apheresis procedures. Reported adverse patient reactions have included: stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, fast heart rate, dizzines, fainting, unresponsiveness, shortness of breath, the feeling of a strong or rapid heartbeat, drug ineffectiveness, burning sensation, redness or paleness of skin, abnormal sensation of the skin, mouth or lips, flushing, increased sweating, decreased skin sensitivity, headache, feeling unwell, restlessness, watery eyes, throat swelling, thirst, bleeding tendencies and difficulty opening the mouth. Some of these reactions, paritcularly profound and refractory hypotension, may be severe or life-threatening.”

Baxter says that adverse reactions have only been noted so far with the heparin multi-dose products, and that the extension of the recall is only being done as a “precaution.” A recent press conference held by officials at the Food & Drug Administration indicated that the February 28, 2008, expansion of the recalled Baxter heparin products was delayed due to concerns about creating a shortage of blood thinners in the United States, but the FDA has now determined that there will be no shortage due to the availability of heparin products from another manufacturer.