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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.

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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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The Zambian president (HE Levy P Mwanawasa, SC.) has finally clinched a deal with Malaysian authorities for the establishment of an economic zone in Lusaka East.

The multi-facility center will be fashioned after the famous Kulim Hi-Technology Park (KHTP) found around the Kedah Region, in the north-west Malaysian Peninsular. 

When fully implemented this economic zone will be an integrated science park targeting technology-related industries primarily in the fields of advanced electronics, mechanical electronics, telecommunications, semiconductors, optoelectronics, biotechnology, advanced materials, research and development and emerging technologies. 

It will incorporate functional areas ranging from industrial, research & development facilities, amenities, medical and educational institutions to recreational facilities in possibly 6 dedicated zones covering the Park. We have managed to provide a visual of such a prospect here below … thanks a trillion.

Brainwave R Mumba, Sr. 

CEO & President – Zambian Chronicle 

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Zambian Chronicle is a wholly owned subsidiary of Microplus Holdings International, Inc. 

Copyrights © 2007 Microplus Holdings Int., Inc.

Industrial Zone
Phase 1 covers an area of 250 hectares and comprises 31 industrial lots, which also features Research & Development (R & D), administrative and other supporting facilities. Phase 2 covers an area of 226 hectares and comprises 14 industrial lots.
Amenity/Recreational Zone
The facilities available:
27-hole championship golf course designed by JMP Golf Design group from the US
Club house
3 blocks of apartments
823 units of bungalow lots
The amenities include a Nature Park accounting 25% of the Hi-Tech Park.
 
Residential/Commercial Zone
The development of a RM600 million satellite township spanning 298 hectares is in progress and will consist of:
Different categories of houses
Shop houses
Office lots
Commercial buildings
Shopping centres
 
Research & Development (R&D) and Training Zone
R&D is an integral and very important feature of high-technology park and is carried out by private companies, public R&D organisations as well as universities located within the high-technology park.
In recognition of this, the KHTP has therefore incorporated an R&D component as part of the overall development.
 
Urban Zone
The urban zone comprises the town centre, the sub-centre and the neighbourhood centre. Being the main commercial centre, the town centre is allocated adjacent to the cross-junction leading to the East-West Expressway.
 
Institutional Zone
This zone comprises public facilities and institutional reserves. The fire and rescue department as well as the Kulim Hospital is already operational.