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TAINTED HEPARIN LINKED TO DEATHS
by Jane Mundy
Heparin acts as a blood thinner by preventing the formation of clots that can trigger heart attacks or strokes. It is mainly used after surgery and is vital for kidney patients to prevent clotting of blood during the dialysis process. About 450,000 people in the US are on dialysis and Heparin is used by almost all of them. As well, patients with clotting problems have been given heparin.
The drug, which is made from the intestines of pigs and the lungs of cattle, has been sold in the United States for over 70 years. It is also used in the treatment of deep vein thrombosis by keeping existing blood clots from getting bigger or preventing new clots from developing. It is also given to home patients to clear out catheters and intravenous lines.
Late last year, four dialysis patients in Missouri, all children, suffered severe allergic reactions within minutes of receiving Heparin made by Baxter Healthcare Corp. (The company sold about 100,000 vials a day, and supplied about half of the Heparin used in the US.) By November, 2007 more than 50 dialysis patients had serious reactions to the drug, making it the largest national outbreak of treatment-related allergic reactions ever seen in dialysis patients.
Baxter recalled nine lots of its multi-dose vials of Heparin, and a Baxter official said some reactions "may be severe or life threatening". The symptoms included facial swelling, nausea, rapid heart beat and rapidly falling blood pressure, which can lead to life-threatening shock and even death.
Adverse reactions increased after the recall and included Heparin lots that had not been recalled. On Monday, February 11, 2008, after reports of 4 deaths and 350 adverse reactions (of which 40 percent were deemed serious) allegedly caused by Heparin, Baxter announced that it would no longer sell multi-dose vials of Heparin. By February 28, the FDA reported that the number of deaths had risen to 21.
The FDA announced on March 21, 2008 that B. Braun Medical Inc. of Mississauga, Ontario began recalling Heparin solutions as a precautionary measure. However, Health Canada went a step further and announced that the company's heparin products were tainted. Braun has recalled 23 lots (of 25,000 units each) that were distributed to Canada, Australia and the United States.
The contaminant, oversulphated chondroitin sulphate, was first found in heparin manufactured by Baxter. The raw ingredient came from China but possibly due to a shortage of pigs (from a disease that recently swept the country), it was doctored with chondroitin sulfate, a dietary supplement made from animal cartilage and used to treat joint pain. When chondroitin sulphate is altered, or "oversulphated," it mimics the blood-thinning action of heparin. The Wall Street Journal reported that "Wang Xiangyang, a factory director at the Zhaoyang Intestine & Casing Factory in Shandong, says his company has been forced to use sheep innards in addition to pig intestines because of a shortage of pig supplies.
Currently, the FDA is uncertain whether chondroitin sulfate was added deliberately or accidentally, but it does know that the doctored drug did not occur naturally or as a result of the manufacturing process.
Scientific Protein Laboratories (SPL) of Waunakee, Wis supplied both B. Braun and Baxter heparin in its raw form and has been supplying heparin to the US for 30 years. SPL initiated Braun's product recall, disclosing that one lot of Heparin Sodium, USP Active Pharmaceutical Ingredient has a "heparin-like contaminant". It owns Changzhou SPL, a company in China that purchases crude heparin from brokers who buy from family farmers. It is thought that the doctoring of the drug may have been done by brokers.
The plant in Changzhou was approved by the FDA to provide heparin to the US in 2004, even though it had not been FDA inspected. Consequently, the FDA is now under fire for approving Baxter's heparin without inspecting the plant in China that manufactured the heparin's active ingredient. An FDA spokesperson said "It was obviously a glitch" that the FDA didn't bother to inspect the site.
The FDA has now admitted that it violated its own policies by neglecting to inspect SPL's Chinese plant before approving the drug for sale in the US.
In the wake of Baxter's recall, The House Oversight and Investigations Subcommittee has scheduled a hearing for April 15 on the distribution of contaminated heparin. The committee is expected to ask the FDA Commissioner how the agency will address concerns regarding its efforts to inspect foreign drug facilities.
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