Heparin Havoc Continues

Bryan A. Liang, MD, PhD, JD


It looks as though the problems from China-sourced heparin are far from over.  An unknown substance, similar in chemical makeup to heparin, has been found in batches of the blood thinner produced by U.S.-based Baxter International and Germany-based Rotexmedica. 


In some cases, this mystery component comprised as much as 20 percent of the contaminated heparin. Unfortunately, we don’t whether this was introduced into the product, whether it was a natural reaction resulting in a byproduct, or if there is some other explanation for the dozens of adverse reactions and at least 19 deaths associated with the product. In any event, it’s worrying for patients and providers who rely on this common drug.

Beyond US and German recalls, three Japanese firms have also announced earlier this week a precautionary heparin recall linked to Scientific Protein Laboratories, which processed the raw materials from China used to make active ingredient in Baxter’s heparin.

At this time, we don’t know the source of the heparin problem. But we do know that in the past, there have been dangerous substitutions made when supply shortages for the raw product have occurred. Unscrupulous suppliers don’t hesitate to use foreign, possibly toxic, materials into a drug’s raw materials if it will save them money. And as I said back in November, it’s easier than ever for counterfeiters to use materials of questionable quality to penetrate the U.S. market since pharmaceutical supply chains are becoming increasingly global-and vulnerable.

If contaminants can penetrate and cause injury in heparin’s legitimate supply chain, just imagine the possibility of them being used in contraband drugs from rogue online sellers.

If you order medicines online, make sure the Web site is part of the Verified Internet Pharmacy Practice Sites (VIPPS) program. The VIPPS identifies online pharmacy sites that are appropriately licensed, are legitimately operating via the Internet, and that have successfully completed a rigorous criteria review and inspection.

It is important to use all the tools and information at our disposal to protect ourselves. Remember, counterfeit drugs are unsafe at any cost.