Another Company Recalls Heparin

(WASHINGTON) — A manufacturer of the blood thinner heparin initiated a nationwide recall Friday because some products may contain a potentially dangerous contaminant. Contaminated heparin from a different manufacturer has been associated with 19 deaths and hundreds of allergic reactions.

In the recall announced Friday, B. Braun Medical Inc. said it was recalling 23 lots of heparin as a precautionary measure. No adverse events have been reported in connection with their product, company officials said in a press release.

The company issued the recall after one of its suppliers, Wisconsin-based Scientific Protein Laboratories, disclosed that an ingredient it provided contained oversulfated chondroitin sulfate, a chemical that does not occur naturally. Federal officials are investigating how the contaminant got into the drug.

Heparin is derived from a mucus obtained from pig intestines and other animal tissues, often processed by small, unregistered workshops in China. Scientific Protein Laboratories owns a Chinese factory — Changzhou SPL — and buys additional raw heparin from other Chinese suppliers.

Scientific Protein Laboratories also supplies Baxter International Inc. Baxter recalled nearly all its U.S.-sold heparin injections after some patients experienced extreme allergic reactions. The lots of heparin linked to hundreds of allergic reactions were marketed by Baxter International and produced in China.

There have been similar recalls of Chinese-sourced heparin in Germany and Japan.

China's drug safety agency recently said that raw heparin suppliers have been required to improve their management and tests on their products.

Typical symptoms of the allergic reaction to heparin include low blood pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain.

Customers in the U.S. and Canada that have received heparin from one of the recalled product lots should discontinue use immediately.

FDA officials said that recall would still allow for an adequate supply of heparin. The heparin that Baxter recalled primarily is used in large-dose injections just prior to surgery. While the heparin from B. Braun Medical Inc., is a pre-mix solution given intravenously, officials said.

The first steps to produce crude heparin, the main ingredient in an anti-clotting medicine, often take place in small factories across China -- many of them primitive. At left, bare-handed workers at Yuan Intestine & Casing Factory, in a small farming village in Shandong province, untangle and flush pig intestines that will be used to make the medication. (Gordon Fairclough)

The men wring pulp from pig intestines and heat it in open cement vats. After further processing by more sophisticated plants, the chemical is made into intravenous drugs given to patients around the world having surgery or patients who need kidney dialysis or blood transfusions. (Gordon Fairclough)

The process for getting raw heparin is rather simple. First, the company picks up barrels of pig intestines from slaughterhouses. (Gordon Fairclough)

Workers use a machine to wring the pulp from the inside of the intestines. (Gordon Fairclough)

Since mid-2006, China's pig herds have suffered serious outbreaks of porcine reproductive and respiratory syndrome. In theory, sick animals are supposed to be rejected, but in practice, enforcement can sometimes be lax. (Gordon Fairclough)

Some earler reports a week or two ago claimed the chondroitin sulfate was difficult to distinguish from the heparin.

If so, it was probably added to raise the Heparin assay and hence the price for the product, just as melamine was added to gluten to falsely raise the Nitrogen Assay for protein content.

In short, $$ used as a measurement where life is worth nothing.

Great Idea!!!

Maybe they can save even more money by harvesting heparin from the Tibet demonstrators.

Amazing and disgusting.

Last summer, I spent 2 long, very painful and horrible months in a Seattle hospital for heart surgery (removal of the sack from around my heart and one of the 3 bi-passes I need ), a stroke during the surgery and MRSA infection that flat took over my entire body. I’m told that I get to go back for another surgery.

I received a daily Heparin shot while there.

Having seen this article, I think I “might” decline Heparin treatment in the future, but what would be the alternative? The shot does sting like heck. ;>) Four months of morphine and Oxycodone was nice though, except for the withdraws of course. ;>)

Believe me, when you are full of pain killers, fighting for survival, in and out of consciousness, feeling like you are 2 seconds from death, you don’t think logically or even evaluate what might be put into you body. Heck, thanks to the stroke, I couldn’t communicate even if I had known what to say. During times like these, you are completely at the mercy of the medical community. They must have called the right shots though, I am still on this side of the dirt, for now.

After months of home recovery and a few setbacks, I bought a Chesapeake Bay retriever, a pup, and I named him after my heart surgeon, Dr. Aldea. ;>)

To survive, for me anyway, it takes a strong and unrelenting will live, a reason to live and very competent folks in the medical community. A faith in God helped when those other things started to break down.

Bottom-line, I would prefer that anything put into my body to have been made in the USA, but when the chips are down, I simply have to trust that my doctors will do all that it takes to allow me one more breath, one more look into my beautiful Brides eyes, one more sunset and one for chance to hear the music of those beautiful words, “Papa, I love you”.

I wish all of you a wonderful Easter. I believe that I will enjoy mine, as according to one of my doctors before the surgery, I was supposed to be dead over 3 months ago.

I hope I didn’t bore you folks. ;>)

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