FDA triples count of deaths linked to tainted heparin

Sixty-two deaths now are 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 still are dying — the latest deaths the FDA knows of occurred in February, the month 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 that 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 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 rare with heparin, the FDA's data shows. Three such deaths were reported in all of 2006, and 13 from January to October 2007.

Then began the spike: Eight such deaths last November, 12 in December, 16 in January and 11 in February. (Two more deaths couldn't be dated.)

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.

On Wednesday, the FDA will urge 82 manufacturers of medical devices that contain or are coated with heparin to test that their supplies are contaminant-free. Most of the recalled heparin so far was in vials, large doses used mostly for patients getting heart surgery or undergoing dialysis. But smaller amounts are used for numerous other purposes, such as coatings on stents and catheters.