Heparin Death toll reaches 62- FDA

At the request of consumers, FDA has announced that according to its latest estimates, 62 deaths have been caused due to heparin infection. Previous agency announcements were limited only to adverse events reported in 2008.

FDA has said that they have received 62 reports of deaths during the last 15 months of patients who were treated with the blood-thinner heparin and suffered allergic reactions or hypotension (low blood pressure.

Heparin is commonly used in dialysis to prevent clotting of the blood when it circulates in a dialysis machine. It makes the blood thinner and thus reduces the loss of the blood during dialysis. Anemic patients can’t afford this blood loss as it could prove fatal for them.

The most common reactions that are developed are difficulty in breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure.

In January, Baxter had voluntarily recalled nine lots of its injectable heparin sodium injection in 1,000-unit vials, after reports of adverse reactions.

Baxter spokeswoman Erin Gardiner however said that the company has identified only four deaths to date where it could recall heparin may have played a role. FDA's numbers include reports from additional sources, including other manufacturers, she clarified.

Another manufacturer, APP Pharmaceuticals spokeswoman Maili Bergman said no deaths have been associated with its product.

FDA had identified the source of the infection to be an ingredient supplied to Baxter by a Chinese manufacturer. They had identified the contaminant present in Baxter’s Heparin to be Hyper-sulphated Chondroitin Sulphate. The compound Chondroitin Sulphate occurs naturally and is used as a dietary supplement to treat joint pain.

China's Health Ministry in its efforts to curb the infection, has urged medical facilities to properly check the medicine they sourced and to keep proper records, so as to trace the source. Doctors must strictly follow relevant regulations when applying heparin products to ensure safety, ministry said.

Baxter supplies about half the heparin used in U.S. Heparin generates about $29 million in annual revenue for Baxter, less than 1 percent of the company's total revenue.

Doctors are already using lesser dosage in order to ensure that there are lesser cases of allergic reactions due to this drug.

Shares of Baxter International Inc. fell 61 cents, or 1 percent, Tuesday to close at $59.83. Shares of APP Pharmaceuticals Inc. rose 6 cents to close at $13.