- The blood-thinner heparin has been found to be contaminated with a synthetic chemical known as oversulfated chondroitin sulfate, which has resulted in numerous allergic reactions and possibly 19 fatalities in the United States.
- Oversulfated chondroitin sulfate is a synthetic version of chondroitin sulfate, which imitates the mechanisms of heparin, and was found in heparin samples manufactured in China for Baxter Healthcare Corp.
- The FDA is investigating whether the introduction of the contaminant to the drug was deliberate or accidental, due to the fact that oversulfated chondroitin sulfate is a cheaper alternative to the active pharmaceutical ingredient in heparin.
- Heparin is widely used in heart surgeries and dialysis, with its primary ingredient sourced from pig intestines, primarily from unregulated farms in China.
- The FDA has stringent safety measures in place for imported heparin, and it assures that the current stock in the market is safe, having undergone extensive testing.
US health authorities have pin-pointed the contaminant that has surfaced in the blood-thinner heparin. A synthetic chemical known as oversulfated chondroitin sulfate has been discovered. This substance has been related to numerous allergic reactions and could possibly be linked to around 19 fatalities in the United States.
What is this Contaminant?
Though the oversulfated chondroitin sulfate was identified in the heparin, officials from the US Food and Drug Administration (FDA) have not clarified its source in the drug. Moreover, it remains uncertain if this alien molecule is directly responsible for the allergic reactions and deaths.
Dr. Janet Woodcock, the chairperson of the FDA’s Center for Drug Evaluation and Research, pointed out that the oversulfated chondroitin sulfate was the solitary contaminant observed in samples of the blood-thinning drug. These samples were manufactured in China for Baxter Healthcare Corp, located in Deerfield, Ill.
Oversulfated Chondroitin Sulfate: A Synthetic Intruder
Understanding Oversulfated Chondroitin Sulfate
Though a variant of chondroitin sulfate, oversulfated chondroitin sulfate, is an artificial entity and does not occur naturally. Chondroitin sulfate itself is a substance derived from animal cartilage and is commonly utilized in supplements to alleviate joint arthritic conditions.
Dr. Woodcock shared via a teleconference, “It is highly possible that chondroitin sulfate was chemically altered to conceive this compound. Unlike chondroitin sulfate, oversulfated chondroitin sulfate imitates heparin’s mechanisms, thus seeming to be heparin during regular tests.”
Where was the Contaminant Found?
This contaminant was discovered in the heparin samples that were tested by the FDA at the Scientific Protein’s Changzhou SPL factory in China, which provided the active ingredient in heparin to Baxter. It was also found in the US in Baxter’s heparin products.
The Uncertainty of the Contaminant’s Origin
There is ambiguity regarding whether this contaminant was deliberately or mistakenly incorporated into the heparin. It is also noted by the FDA that oversulfated chondroitin sulfate is more cost-effective than heparin’s active pharmaceutical ingredient.
“We need to ascertain whether the oversulfated chondroitin sulfate, when mixed with heparin can trigger severe allergic reactions as reported to Baxter and FDA,” said Dr. Woodcock.
Heparin is frequently administered to patients undergoing heart surgery or dialysis. The raw materials for this drug are sourced from the mucosal lining of pig intestines. Most of these pigs are raised on rural farms in China, and the intestines go through a process in unregulated small-scale workshops before additional processing at Scientific Protein’s plant in Changzhou.
Symptoms of Adverse Reactions
Adverse reactions reported include difficulty in breathing, excessive sweating, nausea or vomiting, and a drop in blood pressure, which could potentially progress towards a life-threatening shock.
Understanding the Data
From the end of December, there have been 785 reports of allergic reactions linked to Baxter’s heparin, compared to under 100 reports of harmful reactions for the entirety of 2007. There have also been 46 deaths amongst individuals using heparin, with 19 potentially ascribable to the drug, and a confirmed four, as per the FDA.
Nevertheless, since the recall of Baxter’s heparin batches on February 28, no new deaths have been reported, added Dr. Woodcock.
Safety Measures and Future Direction
Since March 14, the FDA has been examining imported heparin entering the US. According to Dr. Woodcock, “Doctors and patients can now rest assured that the product in the market has undergone testing and is deemed safe.”
Following Dr. Woodcock’s teleconference, Scientific Protein released a statement quoting Robert Rhoades, an independent consultant who has worked with the company’s Changzhou SPL plant in China. He stated that “The contamination identified by the FDA likely happened earlier in the supply chain.”
Get more information
Check out more details about heparin, visit the [U.S. National Library of Medicine].