It's a grim trifecta of heparin news today. Regulators say they've now found 21 deaths that may be linked to Baxter's recalled blood thinner. FDA inspectors uncovered quality-control problems at the Chinese plant where crude heparin was processed for Baxter's supplier. And Baxter widened its recall to include, not just its multidose heparin vials, but single-dose packaging and diluted heparin, Hep-Lock.
Now, there are a few caveats. The 21 people who died while taking Baxter's heparin were very ill and may have died from other causes. The FDA hasn't found a smoking gun at the Chinese plant, so the jury's still out on whether impurities and supply-chain problems there caused the whole debacle. And Baxter's widened recall is a precautionary measure, prompted by the news that rival APP Pharmaceuticals can step in to fill demand.
Nevertheless, the whole episode reads like a tale of globalization gone wrong. Whether the Chinese plant eventually is blamed is, at this point, irrelevant. The curtain has been whipped aside to reveal pig intestines, contaminated vats and overlooked inspections. Not to mention supply chains too convoluted and opaque--and inadequately monitored--to be trusted. Let's hope it's a wake-up call for the FDA and drug makers alike.
- see Baxter's press release about the widened recall
- get the FDA's inspection report
- read more on the possibility of additional deaths in The New York Times
- check out the FDA inspection story in the Washington Post
- find more on the FDA's investigation
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