Contaminant Suspected in Heparin Deaths
ROBERT SIEGEL, host:
This is ALL THINGS CONSIDERED from NPR News. I'm Robert Siegel.
MELISSA BLOCK, host:
And I'm Melissa Block.
The FDA is working to identify a contaminant found in batches of the blood-thinner, Heparin. The agency now says 19 deaths may be linked to the drug. The contaminant was found in an ingredient produced from pig intestines - some of which comes from China. Heparin is used in hospitals and dialysis centers to prevent blood clots.
Anna Mathews has been covering this story for The Wall Street Journal. And Anna, first, can you tell us when there were suspicions that something was wrong with this drug?
Ms. ANNA MATHEWS (Staff Reporter, The Wall Street Journal): Well Baxter, which is the company that makes the product, first saw a spike in reports of reactions in late December, they've said. And they started out by recalling a limited number of batches. And then as they continue to see problems, they halted all production.
BLOCK: And what kind of reactions were these patients having?
Ms. MATHEWS: There are a variety of things they've seen. The FDA has described them as allergic-type reactions. They've seen people with dropping blood pressure and they've seen some dizziness and they have seen - well, they believe, a few deaths.
BLOCK: Now, the FDA says that it has identified a contaminant, but they haven't said what that contaminant is. What did they explain about that?
Ms. MATHEWS: They've been very vague and it's really not clear. They've also said they don't know if the contaminant got in there inadvertently or through some kind of deliberate action. All we know so far is that it is a natural substance - Baxter has said that. And the FDA has also described it as a Heparin-like substance that resembled Heparin enough to fool some of the tests that are typically used.
BLOCK: Now, we mentioned earlier that the active ingredient in Heparin sometimes comes from China. And in fact, the Baxter Heparin uses a supplier from China. How does that factor in here?
Ms. MATHEWS: The FDA has been clear that they still don't know at what stage of production this contaminant entered it. But Baxter has said that all of the Heparin that have the contaminant did come from raw material that had its origin in China.
BLOCK: There was also some confusion about the inspection process and the FDA is saying that it never inspected the Chinese plant in question here because there was confusion about its name. What's that about?
Ms. MATHEWS: The FDA is supposed to inspect a plant before its products starts being used and approved U.S. drug. In this case, the FDA has essentially said the Chinese plant slipped through the cracks. What seems to have happened is that the name of the Chinese facility resembled, or looked like at least, the name of a different facility that had previously been inspected. And apparently, the FDA mistook the one for the other and thought it had inspected this facility at some earlier date, but in fact it never had.
BLOCK: How many suppliers in China are there like this, supplying components of U.S. drugs, and how does the FDA keep track of them?
Ms. MATHEWS: The FDA has a challenge there according to congressional investigators who've looked at the issue. At the end of fiscal 2007, there were approximately 714 facilities in China that were making either finished drug or a direct ingredient for the U.S. market. But the FDA, between 2002 and 2007, inspected at most 21 of them in any given year, which would seem to leave quite a few un-inspected.
BLOCK: Now, what does the drug maker - what does Baxter have to say about all this?
Ms. MATHEWS: Baxter's deeply involved in the investigation. And they've said that they are doing everything they can to track this to its origin. But they have also said that they don't believe that the problems originated in Baxter's own plant, which is in Cherry Hill, New Jersey. And they have tied the concerns to parts of the process overseen by Baxter's supplier, Scientific Protein.
BLOCK: Now, in the meantime, Baxter has recalled its Heparin. What happens to the patients who need Heparin now? Where do they get it?
Ms. MATHEWS: Well, when the problems initially emerged, Baxter actually halted production but didn't initially recall all of the product. And that was because Baxter, in fact, supplies half of this country's supply of multi-dose vials of Heparin. And the FDA and Baxter together decided that it could cause a shortage if they abruptly recalled all of the product. However, the other major supplier of Heparin in the U.S. market, APP, has ramped up its production. And once that happened, the FDA and Baxter decided that Baxter should indeed recall the rest of its product, which they've now done.
BLOCK: Anna Mathews, thanks so much.
Ms. MATHEWS: Thank you.
BLOCK: Anna Mathews covers the FDA for The Wall Street Journal. Also today, due to a German recall of Heparin from a different source, the FDA urged all manufacturers of Heparin ingredients to test their products and posted instructions online.
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