Heparin Probe Focuses On One Contaminant

FDA Suspects Allergic Reactions To Blood Thinner Are Linked To A Heparin-Like Ingredient

(CBS/AP)  Some of Baxter International's recalled blood thinner heparin contained large amounts of a contaminant that might explain hundreds of serious side effects. And the government said Wednesday it's investigating whether what appears to be a fake ingredient got there by accident or by fraud.

The Food and Drug Administration said 19 deaths from allergic-type reactions are now associated with the recalled drug, up from four.

Baxter insisted the contaminant further points suspicion at ingredient suppliers in China, which are under increasing scrutiny after a wave of recalls involving food, drug and toy imports.

The FDA stopped short of ruling out a U.S. connection and cautioned that while the contaminant is a prime suspect, officials haven't yet proved it harmed patients.

"We still don't know whether this inadvertently got into the supply or whether it was actually added," said FDA drug chief Dr. Janet Woodcock. "We can't tell you where the contamination originated."

High-tech testing by Baxter and other groups uncovered a heparin-like compound in batches of the problem drug - a substance not found in batches of problem-free heparin.

The contaminant accounted for between 5 percent and 20 percent of some of the samples tested, what FDA's Woodcock called "significant quantities."

At those amounts, batches of heparin should have been flagged as subpotent in Baxter's routine quality tests - but they didn't, because the contaminant is so chemically close to real heparin that standard testing couldn't tell the difference, Woodcock said.

"I don't understand why it takes deaths and serious injuries to a large number of Americans before the FDA wakes up - this is clearly a wake up call," consumer advocate Dr. Sidney Wolfe told CBS News medical correspondent Dr. Emily Senay.

The FDA is so concerned that later this week it will give manufacturers and other regulatory agencies worldwide instructions on how to check other heparin supplies to be sure the contaminant isn't sneaking in.

Remaining U.S. supplies of heparin, made by Baxter competitor APP Pharmaceuticals, do not show contamination, the FDA stressed.

Heparin is derived from pig intestines, and the heparin-like contaminant is related to a complex group of chemicals also in those intestines, FDA officials said. That's part of the difficulty in determining how the contaminant got into bulk ingredients used to make vials of the injected blood thinner, which are used in patients undergoing dialysis and heart surgery.

Senay reported last week that China has been dealing with a year long struggle with pig disease, though it is not clear that this would have specifically affected the production of heparin.

Counterfeit ingredients from China are a perennial headache for the FDA. If the heparin contamination turns out to be deliberate, it would be reminiscent of last year's scandal when a Chinese company was charged with adding the toxic chemical melamine to an ingredient used in U.S. pet food, killing thousands of dogs and cats. The melamine let the ingredient pass chemical inspections for protein content.

But Baxter referred to the heparin-like compound as "naturally derived," and FDA said it would take more specific identification of the contaminant, among other things, to tell if it could have slipped into the bulk ingredient accidentally, during processing of the pig intestines.

Baxter, which had provided about half the nation's supply, halted production last month after its brand was linked to hundreds of reports of allergic-style reactions, including vomiting, nausea and difficulty breathing. Baxter purchases bulk heparin from Wisconsin-based Scientific Protein Laboratories, or SPL, which in turn owns a Chinese factory and buys additional crude heparin from other Chinese suppliers.

Baxter said it found the contaminant in samples of the ingredient from the China plant, Changzhou SPL, and in samples processed at the Wisconsin factory that came from Chinese-made crude heparin.

"These results suggest that the root cause may be associated with the crude heparin, sourced from China, or from the subsequent processing of that product before it reaches Baxter," the company said.

The vast majority of the world's heparin comes from Chinese ingredients, Baxter officials noted.

"It is premature to conclude that the heparin active pharmaceutical ingredient sourced from China and provided by SPL to Baxter is responsible for these adverse events," the Wisconsin-based SPL said in a statement.

FDA inspectors last week found quality-control problems at the Changzhou factory, a facility the agency had never before inspected - in violation of its own rules - because of a mix-up with the company's name. But the FDA isn't yet sure if those problems are linked to the allergic-style reactions.

The FDA now has 785 reports of side effects among patients taking heparin from any manufacturer, but can't yet say how many are the complications of concern. Last week, the agency put that number at 215. FDA also has a total of 46 reports of deaths, but ruled out a link with many of them and concluded that 19 deaths since January 2007 appear related to allergic-type reactions that triggered Baxter's recall.

[lagioiella]

I think this a legitimate gripe to sue for medical malpractice as is a plastic surgeon who is implanting women with two different size implants for future surgeries and of course future revenue for himself and the government. Unfortunately for those women, laywers "think there is not enough money to be made for them in cases like this" and the courts judge women who get breast implants as "getting what they deserved for being vain." It really pays to be a MAN who is rich and famous to be heard. After all, this is a man''s world.

[notopennshut]

It is time to stop using China as the source of almost all products sold in the US. They absolutely have no controls over anything and it only takes action after problem develop. Sure, we want cheap products, but you must realize the high costs paid by us and those low-wage workers and if we resist this, even having to pay slightly higher costs would be the best solution. There will never be control checks in China and many other countries because it is not warranted by the authorities and corruption is also rampant. You pay for what you get, even death for people and pets.

[brianbwb-2009]

"Heparin is derived from pig intestines, and the heparin-like contaminant is related to a complex group of chemicals also in those intestines, FDA officials said."

Chitterling juice? No thanks, I can''t stand "chitlins"

[jeff-fla]

I really don''t understand. What are we going to do? If China can''t control products. We must stop using this stuff. Plan and simple. They have no controls, no FDA, no oversight. We night as well be buying it from someone making this stuff in the bathtub in there basement. At least it would be made by an American.