Baxter Announces Wide Scale Heparin Recall

As reported in the New York Times, pharmaceutical company Baxter has issued a wide scale recall of heparin products.

Heparin, an important anti-clotting drug used in a multitude of surgical procedures and given to many hospital patients with cardiovascular diseases, including high blood pressure, has recently been the focus of small scale recalls by manufacturer Baxter after indications that contaminated batches of the drug might be to blame for several deaths.

Initially, suspicions were that nine problematic lots of the drug - a small number compared to overall production and use of the drug - might be to blame for four deaths in several states. After examining the issue, Baxter immediately recalled those nine lots citing concerns over the drug's purity. While no definitive explanations were available, a statement from Baxter indicated it was concerned about certain ingredients that entered the production supply chain from Chinese sources.

During this recall, which began in January, Baxter believed that the problem - whatever the origin - was limited to just those nine lots of drug. Further investigation determined that the problem could be more widespread, but, working in consultation with the Food and Drug Administration (FDA), Baxter decided that while it would temporarily halt the production of heparin, it would not "bulk recall" most existing drug because heparin is so necessary to so many many procedures that to do so would likely endanger more lives than leaving it in circulation.

Now, though, the situation has changed. After consulting with other drug manufacturers to ensure that their production schedules could be ramped up, Baxter has issues a full recall of all heparin products manufactured during a "window period" in which contaminated ingredients are thought to have entered the supply chain (along with a buffer period on either end to ensure safety). The change came after new information revealed that contaminated heparin might have accounted for 21 deaths, not the 4 deaths initially reported.

During this period, it is important to realize that despite the large scale of the recall and the accompanying media attention, the number of problems was actually very limited, and occurred only in very specific circumstances. Almost all of the reported problems occurred in kidney dialysis patients who required sudden, large doses of the drug to stop potentially dangerous blood clotting immediately. Heparin is used in small doses tens of thousands of times per day, and no reports of ill effects have been linked to this usage. Patients affected appear to have had an allergic reaction to something in the suspect batches, and reported shortness of breath, itching, and nausea.

All of the potentially contaminated drug is being removed from healthcare system in the United States, and Baxter, working in cooperation with US government agencies, is conducting an intensive investigation to identify the source of the problem.