FDA finds altered chondroitin sulfate in recalled heparin
ROCKVILLE, Md. The Food and Drug Administration on Wednesday revealed that the blood-thinning heparin that had been recalled after a spate of adverse events was contaminated with an adulterated chondroitin sulfate, the ingredient found in many joint health dietary supplements.
The revelation prompted a call from Congress for greater vigilance and scrutiny of foreign-sourced raw ingredients of both prescription and nonprescription pharmaceuticals. “It is unacceptable that Americans have died and been seriously injured by what appears to be deliberate tampering,” stated Sen. Edward Kennedy, D-Mass., in response to the news. “Whether this contaminant was introduced intentionally or by accident, the full force of the law must be brought to bear to bring those responsible to justice. To guard against future abuses, every drug manufacturer needs to inform FDA of where it sources its ingredients and what it is doing to ensure that these ingredients are pure and potent.”
And while the FDA cautiously declined to speculate whether or not the heparin was adulterated with intent, the implications are certainly there—the hyper-sulfated chondroitin sulfate is potentially more abundant and cheaper to produce than heparin.
“Chondroitin sulfate itself is a biologically derived compound that is commonly available,” noted Janet Woodcock, FDA director of the Center for Drug Evaluation and Research, during a press conference Wednesday. “However, over-sulfated chondroitin sulfate is not ordinarily found in nature. It is most likely that ordinary chondroitin sulfate was chemically modified to create this compound that’s found in the contaminant. Over-sulfated chondroitin sulfate, unlike common chondroitin sulfate mimics heparin’s activities and therefore appears to be heparin when subjected to standard tests,” she said.
“At the moment we don’t know definitively whether the contaminant was introduced intentionally or by accident,” she said. But Woodcock did acknowledge that the “FDA’s unraveling of this mystery comes on the one-year anniversary of our discovery of the contaminant melamine in pet food.”
“It seems likely that [the hyper-sulfated chondroitin sulfate] was added intentionally to protect the sales of heparin,” Sen. Kennedy charged in a letter to FDA commissioner Andrew von Eschenbach. “Pigs are the source of heparin but are in short supply in China because of rampant disease, which may have led to use of the contaminant.”
Under a separate letterhead addressing many of the associations representing the drug industry, including the Pharmaceutical Research Manufacturers Association, the Generic Pharmaceutical Association and the Consumer Healthcare Products Association, Kennedy called for industry cooperation in assisting the FDA on protecting America’s drug supply. “Today I have written the FDA to assess this situation and move to ensure the safety of our nation's drug supply,” Kennedy wrote. “I ask you to urge your members to inform the FDA immediately about the source the ingredients and what they are doing to see that the ingredients are pure and potent. I would appreciate a written report from you by March 28, on how your members plan to respond to this request.”
The FDA is currently working with the United States Pharmacopeia on an expedited basis in developing tests that would confirm that heparin imported into the United States was not adulterated with the hyper-sulfated chondroitin sulfate compound.