The Food and Drug Administration announced on Wednesday that it is investigating the blood thinning drug heparin for what appears to be a fake ingredient.
The drug’s distributor, Baxter International, voluntarily recalled nine lots of heparin sodium injection multi-dose vials on January 17, 2008 “as a precautionary measure due to a higher than usual number of reports of adverse patient reactions involving the product and suspended production,” according to a press release.
“The safety and quality of our products is always our highest priority, and we will continue to collaborate with the FDA as we work to determine the cause of the increased rate of adverse reactions and resolve this issue,” said Peter J. Arduini, president of Baxter’s Medication Delivery business.
After 19 deaths related with allergic-type reactions to the drug, the FDA ordered Baxter to recall its remaining heparin products.
“We still don’t know whether this inadvertently got into the supply or whether it was actually added,” said FDA drug chief Dr. Janet Woodcock. “We can’t tell you where the contamination originated.”
The FDA claimed that contaminant was a heparin-like compound that accounted for between 5 percent and 20 percent of some of the samples tested.
Woodcock said that these batches weren’t noticed by Baxter because the contaminant appeared so chemically close to real heparin.
Taken from pig intestines, Heparin is used in patients undergoing dialysis and heart surgery. FDA officials are experiencing difficulties locating the root cause of the contaminated compound which is derived from a group of chemicals also located in pig intestines.
Baxter claimed that the majority of heparin products come from China.
If the contaminated ingredients from China are discovered to be intentional, it would be reminiscent of last year’s scandal when a Chinese company was charged with adding the toxic chemical melamine to an ingredient used in U.S. pet food, killing thousands of dogs and cats, according to Associated Press.
Baxter said it found the contaminant in samples of the ingredient from the China plant, Changzhou SPL, and in samples processed at the Wisconsin factory that came from Chinese-made crude heparin.
“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,” the Wisconsin-based SPL said in a statement.
The Changzhou factory’s first FDA inspection last week produced quality-control issues. The FDA is currently faced with 785 reports of side effects from heparin products.
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