Personal Injury Law

Contaminant Found in Recalled Heparin

By Jane Akre

Over the last year we've seen pet food contaminated with ingredients from China, tainted cold medications and faulty medical devices and now the FDA says that recalled lots of the blood-thinner heparin also contain an unidentified contaminant.

19 people are confirmed dead from allergic reactions associated to heparin use and 785 adverse reports have been linked to heparin since January of last year.

Baxter Healthcare identified the contaminant through sophisticated nuclear magnetic resonance spectroscopy and finds the fake heparin is similar to the blood thinner in its molecular makeup, but not identical.

The company doesn't know if the contamination is accidental or intentional but it has been found in some five to 20 percent of the active pharmaceuticals in some heparin.

It's also not known if the contaminant is what has led to so many injuries but the heparin lots associated with illnesses were all found to have the contaminant. What is also still undetermined is whether the Chinese plant is the source of the contamination.

Wisconsin-based Scientific Protein Laboratories (SPL) has an operation in China that supplies the heparin, made from the lining of a pig's small intestine. The raw material is often obtained from family farms in China to be processed by SPL in Wisconsin or China.

Baxter then purchases the heparin and finishes the manufacturing for market.

As the focus of the contamination investigation now shifts to practices in China, Dr. Jack Trautman, the retired founder of Scientific Protein Labs in Wisconsin tells IB News he decided against opening a Chinese facility 30 years ago. 

When he traveled there in the 1980's to inquire on setting up a similar operation that SPL co-owns today in China, he says "I came away shaking my head. I find it extremely difficult to have quality control half way around the world."

Dr. Trautman says he observed how raw material (pig intestines) was obtained from local what he calls mom and pop operations.

FDA inspectors recently called the workshops that supply pig intestines to SPL "unacceptable".

"That's one of the reasons it's difficult to track down." Dr. Trautman says Chinese workers probably "did something to the raw material before they extracted it."

He believes many things could contaminate heparin, which deteriorates rapidly unless it is stabilized.

"An analogy would be people collecting tree sap in the winter who boil it down but don't make it evaporate. Instead they get a brown reaction and desirable flavors. Carbohydrate molecules are reactive and depend on what's available, if a temperature is too high it starts decomposition."

But Dr. Trautman says he has no idea what contaminated this heparin. He says he's "shocked at what's happened" adding that the Wisconsin facility it "never happened like this". 

Heparin is used in dialysis clinics and emergency rooms and operating rooms across the country to flush IV lines and minimize blood clots. 

Baxter first issued a recall in January after some allergic reactions such as difficulty breathing, sweating, falling blood pressure and deaths were linked to its use. Then last week, the company expanded the recall to include all multi-dose and single dose vials.

Baxter makes half of the heparin used in this country with competitor APP Pharmaceuticals supplying the rest. That company has had no recalls even though some of its raw material is obtained from and processed in China.

Most raw materials for pharmaceutical companies, many medical devices and food originate in China with little scrutiny from the FDA, an agency said to be in crisis and in desperate need of additional funding. A former chief counsel told Congress last month that the agency is "barely hanging on by its fingertips."

The General Accountability Office says it would take 13 years for the FDA to inspect every foreign drug plant exporting to the U.S..

President Bush has suggested an budget increase of three percent next year which reportedly won't keep up with expenses. #

Full post as published by InjuryBoard on March 05, 2008 (boomark / email).