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(CNN) — U.S. health officials said Wednesday they have found a contaminant in a blood-thinning drug produced by Baxter Healthcare Corp. that has been linked to more than a dozen deaths in the United States.

The drug can keep potentially life-threatening blood clots from forming in the veins, arteries, and lungs.

In early February, the Food and Drug Administration launched an investigation and then a recall of some forms of the product.

The scrutiny began after a spike in reports of health problems associated with heparin, a drug made by Baxter from pig intestines at plants in China and Wisconsin.

Though the cause of the problems has not been determined, FDA investigators found “a heparin-like compound — that is not heparin — present in some of the active pharmaceutical ingredients” in both facilities, said Dr. Janet Woodcock, acting director of the FDA’s Center for Drug Evaluation and Research.

The contaminant, which made up 5 percent to 20 percent of each sample tested, “reacts like heparin in some of the conventional tests used for heparin,” which explains why it was not picked up, she told reporters in a conference call.

No causal link between the contaminant and the adverse events has been established yet, Woodcock said.

She added that it was not clear whether the contaminant was added accidentally, as part of the processing or deliberately.

It also was not clear whether the contaminant was introduced in the company’s plant in Wisconsin or the one in China, Woodcock said.

Though she said the exact structure of the contaminant has not been identified, “it is similar to heparin glycans.” Glycans are polysaccharides, a complex class of carbohydrate.

She added it was unclear whether other heparin products used outside the United States might also contain the product.

Later this week, the agency will release recommendations on how manufacturers and regulators can screen for the contaminant, she said.

Last year, pet food made in China was found to be tainted with an ingredient that replaced more expensive protein and that initial tests did not identify as a contaminant. Asked if the heparin contamination could be a similar case, Woodcock said, “It’s possible.”

Doctors have used the blood-thinner for 60 years with “no history of any problems whatsoever,” said the FDA commissioner, Dr. Andrew C. von Eschenbach.

Its intravenous use can keep potentially life-threatening blood clots from forming in the veins, arteries and lungs.

Von Eschenbach said it would be “disingenuous” to expect the agency would be able to inspect “every institution in every case.”

Over the last fiscal year, the agency reported having inspected more than 1,000 foreign plants, a record.

Since the agency issued its report that 19 deaths had been linked to the drug since January 1, 2007, it has received word of another 27 deaths, “but many of those do not fit our definition of this type of event,” Woodcock said.

In all, the FDA has received 785 heparin-linked reports of adverse events — including difficulty breathing, nausea, vomiting, excessive sweating and plummeting blood pressure that can lead to life-threatening shock.

“They’re continuing to come in fairly rapidly because there has been a lot of reporting of this,” she said.

In a written statement, Baxter said its tests have suggested “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.”

Meanwhile, Scientific Protein Laboratories LLC, which supplies the company with the active pharmaceutical ingredients, issued a statement saying it is working with the FDA, Baxter and outside experts to identify the cause of the adverse events.

“Thus far, no conclusions have been reached about the root cause,” it said.

“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.”

It said that its voluntary recall of suspect product was being made as a precaution. 


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I am so speechless –

The report from Pfizer confirms my concerns. This is why I am crying for help. Zambian women have been abused for a long time.

This is not a one person’s mess, it is the world mess. It is not too late to correct our mistakes. The so called melting pot is no longer a melting pot.

There is just evil in every corner of the world. How about the future of Zambian children and the women?

My advice to Zambian people is: 

The last thing you should think of is violent.

You now know about the drug. Learn to say no thank you. Drug companies always blame consumers. What breaks my heart is sending a drug that has problems to a country that has one of the highest rates of HIV/ AIDS.

Please women need a break. One day you will need just one egg from the woman to create your future. What is amazing is, no one takes money to the grave. Wait until God whacks this world. He will start from the lab that created HIV virus.

Each one of us will be judged. Remember Sodom and Gomorrah, Remember Noah’s Ark, go back to history. We all come from one tree, and that is what makes us equal. Can you imagine the earth without women? 

Think about that, the earth with one color. That would have been so boring. The earth looks beautiful with so many colors, and that is why all colors should live. If you can not stand that … pack your bags and go to another planet. 

Do your home work before you wipe out Zambian women? The hint is Zambia is a country of immigrants on a small scale.

Half members of my immediate family are Zambians, Americans, Italians, British, Scottish, Germans, Zimbabweans, and I think Congolese too. That is how my blood is connected to the entire world.

British went were there was money. Northern Rhodesia (Zambia) had the mines. My grand mother was left behind because she was born from a half black woman. Zambian people took in that child, and the child grew up a Zambian without parents. As usual Zambians are wonderful people that respect life, by then, not now.   

My Plea to Pfizer.

For heaven’s sake Zambia should get good drugs.

This country has helped a lot of neighboring countries that are fighting, refugees camps are set up in Zambia. I also rescued some refuges from Congo; they can tell the experiences of being a refugee. 

At least Zambia needs real help, it time Zambia gets real help. Bring HIV and Food supplements, vitamins drugs to save the nation. I refuse to make my mother country a ladder for other people, and when it comes to Zambians seeking help, we are on the bottom of the list, because of the understanding that Zambians are ignorant and dull, as per remarks of the Zambian Health Minister, who I also question his integrity, of putting down his own people, when he as a qualified Minister could not detect other side effects of the drug. If he was that smart, why depend on South Africa. He did not need South Africa to conduct other tests. I did my own  research in two days, After the same Minister went to the media to address the nation about the drug. If I did not read the minister and the consulate article, I would have not known about it. I went on and did my own research, and find out more side effects, on the same drug. Basically I did the Health Minister’s job. He was supposed to do that, before giving the drug to women. The search engine is easy to use. On that note, I need to know why the Zambian Health Minister can not be fired too. If I did not read his article of withdraw of the drug, I would have not known so much about other side effects. Why should the minister go so aggressively to prosecute the technician who did a wrong test, when himself did not alert women about the Black box warning by FDA and the drug company. At least, my sister and friends were not told, at the time it was given to them. So who is to blame here. Drug companies are ruthless, not only did they betray the American government, the drug company has betrayed me as woman. Up to now my sister has severe complications, due to the drug.

There will be no one left. At least spare the youth for the future. By the way I found the example of a pregnancy test with water very mocking and insulting. Zambia’s education system is poor with only two major state universities.

In a middle of the road that goes from Ndola to Kitwe, there is a tree that has been saved for history. Were slaves were sold. Under that tree came our fore fathers that went to build the world. Just like Zambia was a British colony.

America was a British Colony. The first settlers went to America in 1607. And colonized 13 states. Then back and forth to Africa to capture slaves to build all the wealth…

I just get shocked when I see humans behave the way they do towards other humans.

Thanks a trillion,

With a very big disappointment

Belliah K Theise

Chief Operating Officer and Managing Editor

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