Two New Heparin Deaths Spark Renewed Concerns

Lewes, DEA year after the tainted heparin scare over heparin syringes and heparin contamination reverberated around the globe, two new heparin deaths in Delaware are sparking new fears.

While there are still many unanswered questions, two things are certain.

One is the manufacturer: Baxter International, which was one of the manufacturers of heparin embroiled in the tainted heparin catastrophe from last year.

"Secondly, it is believed the heparin that has been associated (if not the cause) of two recent deaths was made from raw material sourced in the United States, rather than China. To that end, tests of the heparin involved in the Delaware deaths did not yield any traces of oversulfated chondroitin sulfate (OCS), which was at the basis of the contaminated Chinese heparin debacle of a year ago.

However, questions remain. Why did two heparin patients die and a third become ill?

According to a story that appeared yesterday in the Wall Street Journal, the two heparin deaths last weekend were confirmed by a spokesperson for Beebe Medical Center in Lewes, Delaware. A third person became ill.

All three were being treated with heparin supplied by Baxter and made from raw materials sourced in the US. It has been reported that there is no specific evidence linking the heparin to the illnesses, or deaths at this time.

There are other differences isolating these two most recent heparin deaths and those of 80 heparin patients from tainted heparin in 2008.

For one thing the two patients who died—a 71-year-old man and a 64-year-old woman—were being treated with premixed intravenous heparin bags. This differs from the 2008 deaths that are said to have involved bulk supplies, heparin vials, heparin syringes and drug-coated medical devices.

A spokesperson for Baxter also said the Delaware patients did not suffer from severe hypotension (low blood pressure), as was the case with the previous heparin problem. Erin Gardiner said the Delaware patients suffered from intracranial bleeding.

Gardiner was adamant that the lots of heparin associated with the Delaware patients were derived from raw materials sourced in the US, not China. And a Beebe Medical Center spokesperson stressed that the facility was not pointing the finger at Baxter. "We don't know what's going on," says Wallace Hudson, "but heparin is the only commonality that we were able to see ourselves."

The Baxter heparin is currently being tested by the US Food and Drug Administration (FDA), which was immediately alerted after the two Delaware patients died. Baxter's own tests did not reveal any sign of OCS, which might have tied the heparin to China had OCS been found.

"There is one lot of heparin we are focusing on, from a North American source," Ms. Gardiner said. "It was not produced by Chinese manufacturers."

The bulk, or raw material used to manufacture Baxter heparin is sourced from Pfizer Inc. Pfizer, for its part has indicated that it has not received any other adverse reactions connected to heparin, beyond the three originating in Delaware.

However, while all concerned are adamant that the bulk material provided by Pfizer to Baxter for the manufacture of heparin came from US sources, a Pfizer spokesperson did say that the company (Pfizer) gets bulk material from both North America and China, but that "Baxter believes the lot used in Delaware used North American raw materials."

There was no mention of a potential mix-up, or if such an error was even possible.

The investigation continues.