FDA triples estimate of heparin deaths
WASHINGTON -- Some 62 deaths are now associated with contaminated batches of the blood thinner heparin, triple the previous estimate, the Food and Drug Administration said Tuesday.
That doesn't mean people are still dying -- the latest deaths the FDA knows of occurred in February, the month Deerfield-based Baxter International recalled contaminated batches.
But dozens of deaths weren't reported to the agency when they happened, only later after the tainted blood thinner made headlines.
On Tuesday, the FDA posted a month-by-month mortality count on its Web site, showing a sudden jump in allergic-style fatal reactions actually began last November -- possibly signaling the time when the contamination began.
The FDA's investigation found a compound derived from animal cartilage sneaked into supplies of raw heparin coming from China. Although scientists haven't yet proved the compound triggered the reactions, it is the chief suspect.
Until now, the FDA has linked the contamination to 19 deaths from allergic-style reactions. Patients who receive heparin often are so sick that it's impossible to prove the cause of death, however, and Baxter has put the death toll at four.
Tuesday's report shows the FDA has learned of 103 deaths among heparin patients since January of 2007 -- 62 of them associated with allergic-style symptoms. The report includes deaths among users of all brands of heparin, not just Baxter's.
Allergic reactions are a rare reality with heparin, the FDA's data shows, with three such deaths reported in 2006 and a few in early 2007.
Now the FDA has reports of eight such deaths last November, 12 in December, 16 in January and 11 in February.
Heparin is derived from pig intestines and China is the world's leading supplier. Investigators have not determined where in the supply chain the contaminant was introduced.
Baxter's supplier, Scientific Protein Laboratories Inc., also sold heparin to other companies, prompting recalls by Covidien Ltd. and B. Braun Medical Inc. Recalls or warnings also have been is sued in Australia, Switzerland, Germany, Italy, Denmark and Japan.