The U.S. Food and Drug Administration said Tuesday that the
number of reported patients who died following heparin use has tripled since
January to 62 from 19.
Heparin, made from ingredients extracted from pig
intestines, is used to prevent blood clots in millions of people with heart conditions,
kidney disease and in surgery.
Expanded analysis of the FDA on blood thinner heparin led to
the discovery of 62 deaths associated with the drug’s reactions and not 19 as
initially reported. The patients presented allergic reactions or hypotension, a
type of dangerously low blood pressure, symptoms usually caused by heparin.
Baxter International Inc. sells the heparin involved in the
reported deaths. The company initially recalled nine lots of its product in February,
after receiving hundreds of reports of allergic reactions possibly linked to
heparin. Shortly after, the company recalled all remaining heparin products.
An FDA investigation revealed that the heparin was
contaminated with a man-made chemical compound known as over-sulfated
chondroitin which is cheaper than heparin, but mimics it.
Erin Gardiner, representative for Baxter International,
which gets the heparin from
FDA representative Karen Riley said the health agency decided to release the additional numbers on heparin deaths at the request of consumers. Anyone interested in the matter will find information on the agency’s Web site.
Riley also said the agency was sending a letter on Tuesday to 82 medical device manufacturers and distributors asking them to make sure any products that contain, or are coated with, heparin are also free from contamination. Some vascular stents and grafts, as well as devices used in pulmonary bypass and in-vitro diagnostic procedures, are coated with heparin.